Weight Loss With Meal-Replacement Therapy in Teens

Not Applicable

Completed

Brief Summary: This study seeks to examine whether meal-replacement therapy is able to enhance weight loss among teens with severe obesity. In addition, we are also interested in examining the degree of weight loss needed to improve important cardiometabolic risk factors among adolescents.

Detailed Description: This study will involve 130 adolescents (ages 13-17 years old) participating in meal replacement therapy and will last one year (12 months).

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). Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.

We will measure the changes in resting metabolic rate, traditional clinical risk markers (TG, HDL-c, LDL-c, TC, glucose, insulin), vascular function, weight-related quality of life, and physical activity.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Type 1 or 2 diabetes mellitus
Previous (within 6 months) or current use of meal replacements
Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
Previous bariatric surgery
If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months
History of treatment with growth hormone
Neurodevelopmental disorder severe enough to impair ability to comply with study protocol
Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse
Females: currently pregnant or planning to become pregnant
Tobacco use
Bulimia nervosa
Endorsement of vomiting, laxative use, and/or diuretic use for weight control (EDE-Q)
Binge eating disorder
Neurological disorder
Hypothalamic obesity
Obesity associated with genetic disorder (monogenetic obesity)
Hyperthyroidism or uncontrolled hypothyroidism
History of cholelithiasis

Arm && Interventions

Group	Intervention	Description
Meal-Replacements Plus	Meal-replacement Therapy	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.
Meal-Replacements	Meal-replacement Therapy	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).

Primary Outcome Measures

Name	Time	Method
Body Mass Index (From Baseline to 1-year)	52 weeks	Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)

Secondary Outcome Measures

Name	Time	Method
Total Fat Mass (kg)	52 Weeks	Change in fat mass from randomization to week 52
Carotid-radial Pulse Wave Velocity (m/s)	52 weeks	Change in measure of arterial stiffness (from baseline to 1-year)
Systolic Blood Pressure	52 weeks	Change in systolic blood pressure (from baseline to 1-year)
HDL	52 Weeks	High Density Lipoprotein (mg/dL)
Insulin	52 Weeks	Insulin (mU/dL)
Diastolic Blood Pressure	52 weeks	Change in diastolic blood pressure (from baseline to 1-year)
Total Glucose	52 Weeks	Total Glucose (mg/dL)
Total Cholesterol	52 Weeks	Total cholesterol (mg/dL)
LDL	52 Weeks	Low Density Lipoprotein (mg/dL)
Impact of Weight-related on Quality of Life	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.
Triglyceride/HDL Cholesterol Ratio	52 weeks	Triglyceride/HDL cholesterol ratio (from baseline to 1-year)

Locations (1): University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States