Weight Loss With Meal-Replacement Therapy in Teens

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Obesity, Severe
• Intervention / Treatment: Dietary supplement: Meal-replacement Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Dietary supplement: Meal-replacement Therapy; We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Experimental: 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.	Dietary supplement: Meal-replacement Therapy; We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Fat Mass (kg)	Change in fat mass from randomization to week 52	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	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.	52 weeks
Systolic Blood Pressure	Change in systolic blood pressure (from baseline to 1-year)	52 weeks
Diastolic Blood Pressure	Change in diastolic blood pressure (from baseline to 1-year)	52 weeks
Total Cholesterol	Total cholesterol (mg/dL)	52 Weeks
HDL	High Density Lipoprotein (mg/dL)	52 Weeks
LDL	Low Density Lipoprotein (mg/dL)	52 Weeks
Triglyceride/HDL Cholesterol Ratio	Triglyceride/HDL cholesterol ratio (from baseline to 1-year)	52 weeks
Total Glucose	Total Glucose (mg/dL)	52 Weeks
Insulin	Insulin (mU/dL)	52 Weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Aaron Kelly, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Weight loss; Cardiometabolic; Meal-replacement therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Pediatric Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: PEDS-2017-25609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No