Weight Loss With Meal-Replacement Therapy in Teens

NCT03137433 | Completed Results DMC

• 1 other identifier: PEDS-2017-25609
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Severe; Pediatric Obesity

Keywords

Weight loss; Cardiometabolic; Meal-replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Total Fat Mass (kg)

  52 Weeks

• Carotid-radial Pulse Wave Velocity (m/s)

  52 weeks

• Impact of Weight-related on Quality of Life

  52 weeks

• Systolic Blood Pressure

  52 weeks

• Diastolic Blood Pressure

  52 weeks

Study Arms (2)

Meal-Replacements

EXPERIMENTAL

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

Meal-Replacements Plus

EXPERIMENTAL

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

Interventions

Meal-replacement Therapy DIETARY_SUPPLEMENT

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

Meal-Replacements; Meal-Replacements Plus

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Gross AC, Freese RL, Bensignor MO, Bomberg EM, Dengel DR, Fox CK, Rudser KD, Ryder JR, Bramante CT, Raatz S, Lim F, Hur C, Kelly AS. Financial Incentives and Treatment Outcomes in Adolescents With Severe Obesity: A Randomized Clinical Trial. JAMA Pediatr. 2024 Aug 1;178(8):753-762. doi: 10.1001/jamapediatrics.2024.1701.

  PMID: 38884967 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Pediatric Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Aaron Kelly, PhD
• Organization: University of Minnesota

kelly105@umn.edu

612-626-3492

Study Officials

• Aaron Kelly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 2, 2017
• Study Start: January 2, 2018
• Primary Completion: September 30, 2022
• Study Completion: April 30, 2023
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)