Trial Outcomes & Findings for Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans (NCT NCT02150837)

Results Overview

The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 \& 2 \& 2 Plan and 17.35 weeks for the 4 \& 2 \& 1 Plan.).

Recruitment status

COMPLETED

Target enrollment

372 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-09-13

Participant Flow

This is a retrospective chart review of Medifast Weight Control Center (MWCC) clients from 21 centers that used either the Medifast 5 \& 2 \& 2 Plan or 4 \& 2 \& 1 Plan for weight loss between 1/2012 and 3/2014 - it is retropsective and observational in nature, so there was no recruitment involved. The plans were evaluated separately and not compared.

Participant milestones

Participant milestones
Measure	5 & 2 & 2 Plan MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Overall Study STARTED	62	310
Overall Study COMPLETED	37	185
Overall Study NOT COMPLETED	25	125

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5 & 2 & 2 Plan n=62 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=310 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.	Total n=372 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants	222 Participants n=7 Participants	277 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	88 Participants n=7 Participants	95 Participants n=5 Participants
Age, Continuous	46.8 years STANDARD_DEVIATION 13.7 • n=5 Participants	53.5 years STANDARD_DEVIATION 14.7 • n=7 Participants	52.4 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	177 Participants n=7 Participants	204 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	133 Participants n=7 Participants	168 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	310 participants n=7 Participants	372 participants n=5 Participants
Weight	327.11 Pounds STANDARD_DEVIATION 64.33 • n=5 Participants	240.00 Pounds STANDARD_DEVIATION 47.83 • n=7 Participants	254.02 Pounds STANDARD_DEVIATION 60.25 • n=5 Participants
BMI	48.7 kg/m2 STANDARD_DEVIATION 9.9 • n=5 Participants	37.7 kg/m2 STANDARD_DEVIATION 6.8 • n=7 Participants	39.5 kg/m2 STANDARD_DEVIATION 8.5 • n=5 Participants
Lean Body Mass	168.52 Pounds STANDARD_DEVIATION 31.46 • n=5 Participants	135.96 Pounds STANDARD_DEVIATION 31.24 • n=7 Participants	140.33 Pounds STANDARD_DEVIATION 33.09 • n=5 Participants
Body Fat Mass	152.46 Pounds STANDARD_DEVIATION 41.36 • n=5 Participants	103.40 Pounds STANDARD_DEVIATION 30.58 • n=7 Participants	110.04 Pounds STANDARD_DEVIATION 36.41 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 \& 2 \& 2 Plan and 17.35 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=37 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=185 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-28.35 Pounds Standard Deviation 15.60	-23.95 Pounds Standard Deviation 12.28

SECONDARY outcome

Timeframe: 12 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=37 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=185 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight	75.7 percentage of subjects	85.4 percentage of subjects

SECONDARY outcome

Timeframe: 12 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=37 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=185 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	40.5 percentage of subjects	50.8 percentage of subjects

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects remaining at 12 weeks had body composition testing performed.

Lean mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=12 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=86 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Lean Mass	-5.47 Pounds Standard Deviation 6.41	-5.31 Pounds Standard Deviation 4.89

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects remaining at 12 weeks had body composition testing performed.

Fat mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=12 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=86 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Fat Mass	-21.09 Pounds Standard Deviation 8.09	-21.25 Pounds Standard Deviation 10.90

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects remaining at 12 weeks had measurement performed.

Abdominal circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=10 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=73 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Abdominal Circumference	-3.70 Inches Standard Deviation 1.30	-4.47 Inches Standard Deviation 2.59

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects remaining at 12 weeks had measurement performed.

Waist circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=10 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=73 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Waist Circumference	-3.55 Inches Standard Deviation 1.83	-3.87 Inches Standard Deviation 2.34

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects remaining at 12 weeks had measurement performed.

Hip circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=10 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=73 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Hip Circumference	-4.18 Inches Standard Deviation 2.96	-3.41 Inches Standard Deviation 2.22

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects were remaining at 12 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=13 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=114 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-17.69 mmHg Standard Deviation 17.61	-11.27 mmHg Standard Deviation 16.65
Blood Pressure Diastolic	-8.38 mmHg Standard Deviation 8.01	-6.60 mmHg Standard Deviation 12.62

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects were remaining at 12 weeks and not all had measurement performed.

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=13 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=111 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-3.62 Beats per minute Standard Deviation 10.04	-2.95 Beats per minute Standard Deviation 10.48

SECONDARY outcome

Timeframe: 12 weeks

Population: Not all subjects were remaining at 12 weeks and not all had measurement performed.

Blood pressure expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) with the percent of participants that improved (e.g. from hypertensive to pre-hypertensive or normal) their blood pressure category from baseline to 12 weeks.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=13 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=114 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Categorical	53.8 Percent of participants	49.1 Percent of participants

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Population: Number of participants with paired data at baseline and final weight loss visit was too small for meaningful analysis.

Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=1 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=6 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Resting Metabolic Rate	10 calories Standard Deviation 0	-216.67 calories Standard Deviation 279.48

SECONDARY outcome

Timeframe: 12 weeks

Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit. (Meal replacement adherence=average number of self-reported daily meal replacements through 12 weeks/nuber of prescribed meal replacements; Attendance adherence=number of visits/number of weeks on plan

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=62 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=310 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence Meal replacement compliance	83.85 Percent Compliant Standard Deviation 16.67	88.79 Percent Compliant Standard Deviation 18.64
Adherence Attendance compliance	83.65 Percent Compliant Standard Deviation 19.09	85.71 Percent Compliant Standard Deviation 17.94

SECONDARY outcome

Timeframe: 1 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=54 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=283 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	1.6 Percent of subjects	3.2 Percent of subjects

SECONDARY outcome

Timeframe: 2 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=56 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=280 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	8.9 Percent of subjects	16.1 Percent of subjects

SECONDARY outcome

Timeframe: 4 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=57 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=289 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	33.3 Percent of subjects	50.2 Percent of subjects

SECONDARY outcome

Timeframe: 8 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=48 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=239 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	72.9 Percent of subjects	76.2 Percent of subjects

SECONDARY outcome

Timeframe: 16 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=151 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	95.8 Percent of subjects	92.7 Percent of subjects

SECONDARY outcome

Timeframe: 20 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=23 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=112 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	95.7 Percent of subjects	94.6 Percent of subjects

SECONDARY outcome

Timeframe: 24 weeks

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=17 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=81 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	88.2 Percent of subjects	96.3 Percent of subjects

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=62 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=306 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight	62.9 Percent of subjects	69.6 Percent of subjects

SECONDARY outcome

Timeframe: 1 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=54 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=283 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	0.0 Percent of subjects	0.0 Percent of subjects

SECONDARY outcome

Timeframe: 2 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=56 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=280 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	0.0 Percent of subjects	0.0 Percent of subjects

SECONDARY outcome

Timeframe: 4 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=57 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=289 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	0.0 Percent of subjects	1.0 Percent of subjects

SECONDARY outcome

Timeframe: 8 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=48 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=239 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	16.7 Percent of subjects	23.0 Percent of subjects

SECONDARY outcome

Timeframe: 16 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=151 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	50.0 Percent of subjects	64.9 Percent of subjects

SECONDARY outcome

Timeframe: 20 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=23 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=112 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	56.5 Percent of subjects	69.6 Percent of subjects

SECONDARY outcome

Timeframe: 24 weeks

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=17 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=81 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	58.8 Percent of subjects	75.3 Percent of subjects

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 \& 2 \& 2 and 4 \& 2 \& 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=62 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=306 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight	29.0 Percent of subjects	39.9 Percent of subjects

SECONDARY outcome

Timeframe: 4 weeks

Lean mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=26 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=177 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Lean Mass	-5.19 Pounds Standard Deviation 5.42	-4.50 Pounds Standard Deviation 4.66

SECONDARY outcome

Timeframe: 8 weeks

Lean mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=11 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=96 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Lean Mass	-8.36 Pounds Standard Deviation 5.67	-4.49 Pounds Standard Deviation 5.36

SECONDARY outcome

Timeframe: 16 weeks

Lean mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=8 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=55 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Lean Mass	-11.15 Pounds Standard Deviation 4.62	-4.29 Pounds Standard Deviation 6.45

SECONDARY outcome

Timeframe: 20 weeks

Lean mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=6 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=44 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Lean Mass	-13.83 Pounds Standard Deviation 5.33	-5.08 Pounds Standard Deviation 6.96

SECONDARY outcome

Timeframe: 24 weeks

Population: Not all subjects were remaining at 24 weeks and not all had measurement performed.

Lean mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=3 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=55 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Lean Mass	-14.35 Pounds Standard Deviation 9.14	-6.79 Pounds Standard Deviation 6.45

SECONDARY outcome

Timeframe: 4 weeks

Fat mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=26 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=177 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Fat Mass	-11.46 Pounds Standard Deviation 6.92	-9.09 Pounds Standard Deviation 7.71

SECONDARY outcome

Timeframe: 8 weeks

Fat mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=11 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=106 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Fat Mass	-17.35 Pounds Standard Deviation 5.80	-16.27 Pounds Standard Deviation 8.16

SECONDARY outcome

Timeframe: 16 weeks

Fat mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=8 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=70 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Fat Mass	-26.38 Pounds Standard Deviation 9.11	-26.34 Pounds Standard Deviation 12.16

SECONDARY outcome

Timeframe: 20 weeks

Fat mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=6 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=53 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Fat Mass	-34.03 Pounds Standard Deviation 11.64	-29.03 Pounds Standard Deviation 17.00

SECONDARY outcome

Timeframe: 4 weeks

Abdominal circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=27 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=158 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Abdominal Circumference	-2.81 Inches Standard Deviation 2.08	-1.86 Inches Standard Deviation 1.71

SECONDARY outcome

Timeframe: 8 weeks

Abdominal circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=16 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=86 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Abdominal Circumference	-4.42 Inches Standard Deviation 3.04	-3.28 Inches Standard Deviation 1.99

SECONDARY outcome

Timeframe: 16 weeks

Abdominal circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=6 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=63 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Abdominal Circumference	-5.71 Inches Standard Deviation 1.19	-4.46 Inches Standard Deviation 2.73

SECONDARY outcome

Timeframe: 20 weeks

Abdominal circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=7 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=41 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Abdominal Circumference	-6.25 Inches Standard Deviation 1.89	-5.78 Inches Standard Deviation 3.06

SECONDARY outcome

Timeframe: 24 weeks

Abdominal circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=3 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=24 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Abdominal Circumference	-4.83 Inches Standard Deviation 5.16	-5.98 Inches Standard Deviation 2.74

SECONDARY outcome

Timeframe: 4 weeks

Waist circumference expressed as an absolute from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=27 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=158 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Waist Circumference	-2.21 Inches Standard Deviation 1.49	-1.97 Inches Standard Deviation 1.37

SECONDARY outcome

Timeframe: 8 weeks

Waist circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=16 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=86 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Waist Circumference	-3.60 Inches Standard Deviation 2.42	-3.24 Inches Standard Deviation 1.72

SECONDARY outcome

Timeframe: 16 weeks

Waist circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=6 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=63 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Waist Circumference	-4.38 Inches Standard Deviation 2.06	-4.75 Inches Standard Deviation 2.22

SECONDARY outcome

Timeframe: 20 weeks

Waist circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=7 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=41 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Waist Circumference	-6.93 Inches Standard Deviation 2.49	-5.32 Inches Standard Deviation 2.70

SECONDARY outcome

Timeframe: 24 weeks

Waist circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=3 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=24 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Waist Circumference	-3.92 Inches Standard Deviation 3.89	-5.35 Inches Standard Deviation 2.88

SECONDARY outcome

Timeframe: 4 weeks

Hip circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=27 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=158 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Hip Circumference	-2.40 Inches Standard Deviation 1.88	-1.56 Inches Standard Deviation 1.36

SECONDARY outcome

Timeframe: 8 weeks

Hip circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=14 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=86 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Hip Circumference	-3.34 Inches Standard Deviation 1.99	-2.68 Inches Standard Deviation 1.64

SECONDARY outcome

Timeframe: 16 weeks

Hip circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=6 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=63 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Hip Circumference	-4.42 Inches Standard Deviation 3.02	-3.97 Inches Standard Deviation 2.15

SECONDARY outcome

Timeframe: 20 weeks

Hip circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=6 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=41 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Hip Circumference	-5.38 Inches Standard Deviation 1.90	-5.38 Inches Standard Deviation 3.96

SECONDARY outcome

Timeframe: 24 weeks

Hip circumference expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=3 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=24 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Hip Circumference	-5.17 Inches Standard Deviation 3.33	-4.92 Inches Standard Deviation 2.68

SECONDARY outcome

Timeframe: 1 weeks

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=165 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-4.63 mmHg Standard Deviation 17.17	-5.80 mmHg Standard Deviation 14.05
Blood Pressure Diastolic	-2.63 mmHg Standard Deviation 10.49	-3.59 mmHg Standard Deviation 9.98

SECONDARY outcome

Timeframe: 2 weeks

Population: Not all subjects were remaining at 2 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=22 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=174 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-6.41 mmHg Standard Deviation 15.63	-8.53 mmHg Standard Deviation 13.97
Blood Pressure Diastolic	-2.91 mmHg Standard Deviation 9.89	-5.37 mmHg Standard Deviation 10.84

SECONDARY outcome

Timeframe: 4 weeks

Population: Not all subjects were remaining at 4 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=26 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=175 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-7.81 mmHg Standard Deviation 19.76	-9.87 mmHg Standard Deviation 16.93
Blood Pressure Diastolic	-7.31 mmHg Standard Deviation 9.00	-5.90 mmHg Standard Deviation 12.13

SECONDARY outcome

Timeframe: 8 weeks

Population: Not all subjects were remaining at 8 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=144 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-14.21 mmHg Standard Deviation 26.06	-7.51 mmHg Standard Deviation 14.68
Blood Pressure Diastolic	-9.25 mmHg Standard Deviation 11.30	-6.11 mmHg Standard Deviation 11.09

SECONDARY outcome

Timeframe: 16 weeks

Population: Not all subjects were remaining at 16 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=11 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=95 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-19.27 mmHg Standard Deviation 25.09	-10.59 mmHg Standard Deviation 17.03
Blood Pressure Diastolic	-8.55 mmHg Standard Deviation 11.60	-6.84 mmHg Standard Deviation 9.94

SECONDARY outcome

Timeframe: 20 weeks

Population: Not all subjects were remaining at 20 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=11 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=70 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-21.55 mmHg Standard Deviation 20.62	-9.34 mmHg Standard Deviation 17.49
Blood Pressure Diastolic	-8.55 mmHg Standard Deviation 11.12	-6.26 mmHg Standard Deviation 13.05

SECONDARY outcome

Timeframe: 24 weeks

Population: Not all subjects were remaining at 24 weeks and not all had measurement performed.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=9 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=52 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-14.33 mmHg Standard Deviation 16.19	-7.79 mmHg Standard Deviation 19.40
Blood Pressure Diastolic	-5.44 mmHg Standard Deviation 8.41	-3.92 mmHg Standard Deviation 14.18

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Population: Not all subjects had measurement performed at their final visit.

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=163 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Blood Pressure Systolic	-16.96 mmHg Standard Deviation 21.79	-9.52 mmHg Standard Deviation 15.62
Blood Pressure Diastolic	-7.08 mmHg Standard Deviation 10.68	-5.64 mmHg Standard Deviation 11.58

SECONDARY outcome

Timeframe: 1 weeks

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=162 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-0.46 Beats per minute Standard Deviation 12.86	1.07 Beats per minute Standard Deviation 9.42

SECONDARY outcome

Timeframe: 2 weeks

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=22 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=173 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-3.27 mmHg Standard Deviation 10.27	-1.21 mmHg Standard Deviation 9.94

SECONDARY outcome

Timeframe: 4 weeks

Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=26 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=175 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-1.62 Beats per minute Standard Deviation 12.52	-2.88 Beats per minute Standard Deviation 10.11

SECONDARY outcome

Timeframe: 8 weeks

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=142 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-1.17 Beats per minute Standard Deviation 17.84	-2.65 Beats per minute Standard Deviation 10.71

SECONDARY outcome

Timeframe: 16 weeks

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=11 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=95 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-3.27 Beats per minute Standard Deviation 11.29	-3.73 Beats per minute Standard Deviation 11.89

SECONDARY outcome

Timeframe: 20 weeks

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=11 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=71 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	0.27 Beats per minute Standard Deviation 13.27	-2.31 Beats per minute Standard Deviation 11.78

SECONDARY outcome

Timeframe: 24 weeks

Pulse expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=9 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=51 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	0.00 Beats per minute Standard Deviation 4.66	-3.67 Beats per minute Standard Deviation 9.34

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=161 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Pulse	-2.29 Beats per minute Standard Deviation 10.75	-2.29 Beats per minute Standard Deviation 11.63

SECONDARY outcome

Timeframe: 4 weeks

Adherence will be assessed through documented use of meal replacements at each visit.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=53 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=276 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence	94.53 Percent compliance meal replacements Standard Deviation 13.09	96.29 Percent compliance meal replacements Standard Deviation 14.45

SECONDARY outcome

Timeframe: 8 weeks

Adherence will be assessed through documented use of meal replacements at each visit.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=47 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=225 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence	88.3 Percent compliance meal replacements Standard Deviation 20.99	95.17 Percent compliance meal replacements Standard Deviation 14.97

SECONDARY outcome

Timeframe: 16 weeks

Adherence will be assessed through documented use of meal replacements at each visit.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=21 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=145 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence	79.52 Percent compliance meal replacements Standard Deviation 26.55	94.29 Percent compliance meal replacements Standard Deviation 17.19

SECONDARY outcome

Timeframe: 20 weeks

Adherence will be assessed through documented use of meal replacements at each visit.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=20 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=107 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence	89.00 Percent compliance meal replacements Standard Deviation 18.04	89.25 Percent compliance meal replacements Standard Deviation 26.79

SECONDARY outcome

Timeframe: 24 weeks

Adherence will be assessed through documented use of meal replacements at each visit.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=15 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=74 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence	90.67 Percent compliance meal replacements Standard Deviation 14.86	91.22 Percent compliance meal replacements Standard Deviation 23.47

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Adherence will be assessed through documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.).

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=58 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=273 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Adherence	82.41 Percent compliance meal replacements Standard Deviation 27.49	85.26 Percent compliance meal replacements Standard Deviation 29.43

SECONDARY outcome

Timeframe: 1 week

Change in body weight from baseline reported as absolute change.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=54 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=283 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-7.64 Pounds Standard Deviation 4.86	-5.95 Pounds Standard Deviation 3.33

SECONDARY outcome

Timeframe: 2 weeks

Change in body weight from baseline reported as absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=56 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=280 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-9.71 Pounds Standard Deviation 4.95	-8.24 Pounds Standard Deviation 4.27

SECONDARY outcome

Timeframe: 4 weeks

Change in body weight from baseline reported absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=57 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=289 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-14.26 Pounds Standard Deviation 6.88	-12.25 Pounds Standard Deviation 6.01

SECONDARY outcome

Timeframe: 8 weeks

Change in body weight from baseline reported as absolute change.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=48 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=239 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-22.81 Pound Standard Deviation 11.21	-18.32 Pound Standard Deviation 9.21

SECONDARY outcome

Timeframe: 16 weeks

Change in body weight from baseline reported as absolute change.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=24 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=151 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-36.89 Pounds Standard Deviation 16.45	-28.84 Pounds Standard Deviation 14.48

SECONDARY outcome

Timeframe: 20 weeks

Change in body weight from baseline reported as absolute change.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=23 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=112 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-40.51 Pounds Standard Deviation 19.08	-32.42 Pounds Standard Deviation 16.22

SECONDARY outcome

Timeframe: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Change in body weight from baseline to final weight loss visit reported as absolute change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 \& 2 \& 2 Plan and 17 weeks for the 4 \& 2 \& 1 Plan.)

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=62 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=306 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Body Weight	-29.25 Pounds Standard Deviation 27.65	-23.34 Pounds Standard Deviation 18.65

SECONDARY outcome

Timeframe: 24 weeks

Population: Not all subjects remaining at 24 weeks had body composition testing performed.

Fat mass expressed as an absolute change from baseline.

Outcome measures

Outcome measures
Measure	5 & 2 & 2 Plan n=4 Participants MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=35 Participants MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Fat Mass	-56.88 Pounds Standard Deviation 18.52	-32.00 Pounds Standard Deviation 15.76

Adverse Events

5 & 2 & 2 Plan

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

4 & 2 & 1 Plan

Serious events: 9 serious events

Other events: 219 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5 & 2 & 2 Plan n=62 participants at risk MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=310 participants at risk MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Vascular disorders Stroke	0.00% 0/62 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.32% 1/310 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Cardiac disorders Heart attack	0.00% 0/62 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.32% 1/310 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Surgical and medical procedures cholecystectomy	1.6% 1/62 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.65% 2/310 • Number of events 2 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Vascular disorders Bloot clot	0.00% 0/62 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.32% 1/310 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Infections and infestations Fever	0.00% 0/62 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.32% 1/310 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Surgical and medical procedures Ruptured hemorrhoid	0.00% 0/62 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.32% 1/310 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Vascular disorders Mini-stroke	1.6% 1/62 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.00% 0/310 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders Hospitalization	0.00% 0/62 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	0.65% 2/310 • Number of events 2 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.

Other adverse events

Other adverse events
Measure	5 & 2 & 2 Plan n=62 participants at risk MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss. 5 \& 2 \& 2 Plan: Medifast has developed the 5 \& 2 \& 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 \& 2 \& 2 Plan consists of 5 Medifast meal replacements, 2 Lean \& Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, \>72g protein, \>100g of carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	4 & 2 & 1 Plan n=310 participants at risk MWCC members who used the Medifast 4 \& 2 \& 1 Meal Replacement Plan for weight loss. 4 \& 2 \& 1 Plan: Medifast has developed the 4 \& 2 \& 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (\>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 \& 2 \& 1 Plan consists of 4 Medifast meal replacements, 2 Lean \& Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, \>72g protein, \>100g carbohydrate, and \<30% of calories from fat. The Lean \& Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Gastrointestinal disorders constipation	14.5% 9/62 • Number of events 9 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	10.6% 33/310 • Number of events 33 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Gastrointestinal disorders gas/bloating	1.6% 1/62 • Number of events 1 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	7.1% 22/310 • Number of events 22 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders hunger	19.4% 12/62 • Number of events 12 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	18.1% 56/310 • Number of events 56 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders fatigue	4.8% 3/62 • Number of events 3 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	11.0% 34/310 • Number of events 34 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders stress/anxiety	8.1% 5/62 • Number of events 5 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	5.2% 16/310 • Number of events 16 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders Sick Not Otherwise Specified	21.0% 13/62 • Number of events 13 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	22.3% 69/310 • Number of events 69 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders cravings	8.1% 5/62 • Number of events 5 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	4.5% 14/310 • Number of events 14 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
General disorders Headache	9.7% 6/62 • Number of events 6 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.	3.9% 12/310 • Number of events 12 • Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months). This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.

Additional Information

Chris Coleman

Medifast

Phone: 410-504-8161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place