Trial Outcomes & Findings for Weight Loss With Meal-Replacement Therapy in Teens (NCT NCT03137433)

NCT ID: NCT03137433

Last Updated: 2024-03-22

Results Overview

Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 126 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2024-03-22

Participant Flow

Participant milestones

Measure	Meal-Replacements Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Overall Study STARTED	63	63
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	19	18

Reasons for withdrawal

Measure	Meal-Replacements Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements; this group of individuals received financial incentives as part of their weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Overall Study Withdrawal by Subject	11	11
Overall Study Lost to Follow-up	5	6
Overall Study Physician Decision	2	0
Overall Study Moved out of study area	1	0
Overall Study Too far out of window due to COVID	0	1

Baseline Characteristics

Weight Loss With Meal-Replacement Therapy in Teens

Baseline characteristics by cohort

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group was provided additional information to go along with meal-replacements which was that they would be paid for their weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Total n=126 Participants Total of all reporting groups
Age, Categorical <=18 years	63 Participants n=5 Participants	63 Participants n=7 Participants	126 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	55 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Body Mass Index (From Baseline to 1-year)	-0.9 Percent change in BMI Standard Deviation 1.3	-6.6 Percent change in BMI Standard Deviation 1.6

SECONDARY outcome

Timeframe: 52 Weeks

Change in fat mass from randomization to week 52

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Total Fat Mass (kg)	-1.3 Kg Standard Deviation 1.5	-6.1 Kg Standard Deviation 1.5

SECONDARY outcome

Timeframe: 52 weeks

Change in measure of arterial stiffness (from baseline to 1-year)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Carotid-radial Pulse Wave Velocity (m/s)	-0.1 m/s Standard Deviation 0.1	0.1 m/s Standard Deviation 0.2

SECONDARY outcome

Timeframe: 52 weeks

Impact of Weight-related on Quality of Life Total Transformed Score (from physical comfort transformed score, body self esteem transformed score, social life transformed score, and family relations transformed score). Scores range from 0 to 100 with 100 representing the best quality of life.

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Impact of Weight-related on Quality of Life	3.2 score on a scale Standard Deviation 2.5	5.2 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 52 weeks

Change in systolic blood pressure (from baseline to 1-year)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Systolic Blood Pressure	-3.1 mm Hg Standard Deviation 1.7	-2.1 mm Hg Standard Deviation 1.7

SECONDARY outcome

Timeframe: 52 weeks

Change in diastolic blood pressure (from baseline to 1-year)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Diastolic Blood Pressure	-0.3 mm Hg Standard Deviation 1.4	0.1 mm Hg Standard Deviation 1.5

SECONDARY outcome

Timeframe: 52 Weeks

Total cholesterol (mg/dL)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Total Cholesterol	153.9 mg/dL Standard Deviation 30	158.6 mg/dL Standard Deviation 32

SECONDARY outcome

Timeframe: 52 Weeks

High Density Lipoprotein (mg/dL)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
HDL	43.6 mg/dL Standard Deviation 9	44.0 mg/dL Standard Deviation 10

SECONDARY outcome

Timeframe: 52 Weeks

Low Density Lipoprotein (mg/dL)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
LDL	89.1 mg/dL Standard Deviation 29	89.3 mg/dL Standard Deviation 30

SECONDARY outcome

Timeframe: 52 weeks

Triglyceride/HDL cholesterol ratio (from baseline to 1-year)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Triglyceride/HDL Cholesterol Ratio	-0.2 TG/HDL cholesterol ratio Standard Deviation 0.3	-0.5 TG/HDL cholesterol ratio Standard Deviation 0.3

SECONDARY outcome

Timeframe: 52 Weeks

Total Glucose (mg/dL)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Total Glucose	87.3 mg/dL Standard Deviation 9	87.4 mg/dL Standard Deviation 6

SECONDARY outcome

Timeframe: 52 Weeks

Insulin (mU/dL)

Outcome measures

Measure	Meal-Replacements n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 Participants Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Insulin	28.3 mU/dL Standard Deviation 16	34.2 mU/dL Standard Deviation 25

Adverse Events

Meal-Replacements

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Meal-Replacements Plus

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Meal-Replacements n=63 participants at risk Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 participants at risk Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Respiratory, thoracic and mediastinal disorders Exacerbation of Asthma	0.00% 0/63 • 52 weeks	1.6% 1/63 • 52 weeks
Psychiatric disorders Suicide attempt	1.6% 1/63 • Number of events 1 • 52 weeks	0.00% 0/63 • 52 weeks
Psychiatric disorders Overdose	1.6% 1/63 • Number of events 1 • 52 weeks	0.00% 0/63 • 52 weeks
Respiratory, thoracic and mediastinal disorders Acquired pneumonia and E-cigarette associated lung injury (EVALI)	1.6% 1/63 • Number of events 1 • 52 weeks	0.00% 0/63 • 52 weeks

Other adverse events

Measure	Meal-Replacements n=63 participants at risk Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.	Meal-Replacements Plus n=63 participants at risk Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Psychiatric disorders Self report of taking laxatives	11.1% 7/63 • Number of events 7 • 52 weeks	9.5% 6/63 • Number of events 9 • 52 weeks
Psychiatric disorders Self induced vomiting	14.3% 9/63 • Number of events 10 • 52 weeks	9.5% 6/63 • Number of events 10 • 52 weeks

Additional Information

Aaron Kelly, PhD

University of Minnesota

Phone: 612-626-3492

Email: kelly105@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place