Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

NCT05125822 | Recruiting DMC

• 2 other identifiers: PEDS-2021-30024STUDY00014425
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables. Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (3)

• Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)

  We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.

  17 weeks.

• Change in ghrelin

  We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.

  17 weeks.

• Change in gastric inhibitory polypeptide

  We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.

  17 weeks

Study Arms (1)

Meal Replacement and Lifestyle Therapy

EXPERIMENTAL

Participants in this study will have an 8-week meal replacement therapy period in which they are asked to reduce their BMI by 5% by following a prescribed eating regimen consisting of meal replacement shakes and/or frozen meals for breakfast and lunch. For dinner they will consume a pre-packaged frozen entree to be consumed with two servings of fruit and three servings of vegetables per day. Participants will also have lifestyle/behavioral modification counseling every 2 weeks throughout the entire study.

Other: Meal replacement and lifestyle modification

Interventions

Meal replacement and lifestyle modification OTHER

Meal replacement and lifestyle modification

Meal Replacement and Lifestyle Therapy

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to less than 16 years old
• BMI \> 30 kg/m\^2 or 95th BMI percentile
• Tanner stage 2, 3, or 4

You may not qualify if:

• Tanner stage 1 and 5
• Prior bariatric surgery
• Monogenic and hypothalamic obesity
• Polycystic ovary syndrome (diagnosed by a physician)
• Pregnancy or planned pregnancy
• Current use of supplemental hormones
• Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder
• Type 1 or 2 diabetes
• Treatment with growth hormones
• Thyroid disease/problem
• Has had cancer in the last 10 years

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Justin Ryder, PhD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Ryder, PhD

CONTACT

3148826838; jryder@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group study that will consist of two interventions: an 8-week meal replacement therapy period in which participants are asked to reduce their body mass index (BMI) by \>/= 5% by following a prescribed eating regimen and standardized lifestyle/behavior modification counseling which will occur every 2 weeks throughout the study.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: August 26, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (1)