Weight Loss With Meal-Replacement Therapy in Teens

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity

Conditions
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Obesity, Severe, Pediatric Obesity

Intervention / Treatment
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* Dietary Supplement: Meal-replacement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2 13-17 years old 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal-Replacements<br>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). | Dietary Supplement: Meal-replacement Therapy<br>* We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.<br>|
| Experimental: Meal-Replacements Plus<br>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. | Dietary Supplement: Meal-replacement Therapy<br>* We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (from baseline to 1-year) | % change in BMI (kg/m2) | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Fatness (%) | Change in BF% (from baseline to 1-year) | 52 Weeks | 
| Carotid- and radial artery augmentation index | Change in measure of arterial stiffness (from baseline to 1-year) | 52 weeks | 
| Carotid-radial pulse wave velocity (m/s) | Change in measure of arterial stiffness (from baseline to 1-year) | 52 weeks | 
| Impact of Weight-related on Quality of Life | Change in Weight-related QOL (from baseline to 1-year) | 52 weeks | 
| Lipids (HDL-c, LDL-c, TC, TG) | Change in lipids (from baseline to 1-year) | 52 weeks | 
| Blood Pressure | Change in blood pressure (from baseline to 1-year) | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Cardiometabolic, Meal-replacement therapy