Recruiting

Observational Study

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT05125822

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 11 - 15

Healthy Volunteers: Not accepted

Interventions

Meal replacement and lifestyle modification

Study Details

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

Study ID

NCT05125822

Start date

Aug 26, 2023

Status verified date

May, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Tanner stage 1 and 5
  • Prior bariatric surgery
  • Current or recent (< 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
  • 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

Study Design

Enrollment

260 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Meal Replacement and Lifestyle Therapy

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.

Interventions

Meal replacement and lifestyle modification

Meal replacement and lifestyle modification

Primary outcome measure

  • Change in fat mass regain after initial weight loss with meal replacement therapy (MRT) [ Time Frame: 17 weeks. ]
  • Change in ghrelin [ Time Frame: 17 weeks. ]
  • Change in gastric inhibitory polypeptide [ Time Frame: 17 weeks ]

Central Contacts and Locations

Central contacts

Justin Ryder, PhD

3148826838jryder@luriechildrens.org

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Justin R Ryder

3148826838jryder@luriechildrens.org

Principal Investigator:

Justin Ryder, PhD

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-06-02.