Home › Obesity in Children › NCT05125822

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Who can join

Ages 11 to 15 · All sexes

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

About the study

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.

What is being tested

• Meal replacement and lifestyle modification (other)

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Participants: 260 · Started: Aug 26, 2023

Contact the study team

• Justin Ryder, PhD · Phone: 3148826838

Official record on ClinicalTrials.gov — NCT05125822

Locations in the U.S.

Conditions

• Obesity in Children

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.