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

NCT ID: NCT02150837

Last Updated: 2019-09-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.

The study hypothesis is that the 5 \& 2 \& 2 Meal Replacement Plan and the 4 \& 2 \& 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

5 & 2 & 2 Plan

MWCC members who used the Medifast 5 \& 2 \& 2 Meal Replacement Plan for weight loss.

5 & 2 & 2 Plan

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult males and females, 18 years of age or older at the start of the weight loss program.
* Subject has a BMI ≥ 25 kg/m2.
* Subject started a weight management program at the MWCC location on or after January 1, 2012.
* Subject followed the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.
* Subject signed the Personal Health Information Consent Form.

Exclusion Criteria

* Subject was concurrently following another weight loss program other than the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan while on that respective plan.
* Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 \& 2 \& 2 Plan or the 4 \& 2 \& 1 Plan.
* Subject completed initial consultation but did not participate in any follow-up visits.
* Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)
* Written request by subject to revoke consent to use health information is present in subject chart.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medifast, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Linda M Aterburn, PhD

Role: PRINCIPAL_INVESTIGATOR

Medifast, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medifast, Inc.

Owings Mills, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Coleman CD, Kiel JR, Mitola AH, Langford JS, Davis KN, Arterburn LM. Effectiveness of a Medifast meal replacement program on weight, body composition and cardiometabolic risk factors in overweight and obese adults: a multicenter systematic retrospective chart review study. Nutr J. 2015 Aug 6;14:77. doi: 10.1186/s12937-015-0062-8.

Reference Type DERIVED
PMID: 26245279 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MED 017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Variations in Ketone Metabolism
NCT05924295 RECRUITING NA