Weight Loss With Meal-Replacement Therapy in Teens

University of Minnesota126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Obesity, Severe Pediatric Obesity

Interventions

Meal-replacement TherapyDIETARY_SUPPLEMENT

We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Body Mass Index (From Baseline to 1-year)

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

Time frame: 52 weeks

Secondary Outcomes

Total Fat Mass (kg)

Change in fat mass from randomization to week 52

Time frame: 52 Weeks

Carotid-radial Pulse Wave Velocity (m/s)

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

Time frame: 52 weeks

Impact of Weight-related on Quality of Life

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.

Time frame: 52 weeks

Systolic Blood Pressure

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

Time frame: 52 weeks

Diastolic Blood Pressure

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

Time frame: 52 weeks

Total Cholesterol

Total cholesterol (mg/dL)

Time frame: 52 Weeks

HDL

High Density Lipoprotein (mg/dL)

Time frame: 52 Weeks

Data from ClinicalTrials.gov

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