Actively Recruiting
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2026-06-02
260
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying weight regain in youth with obesity to understand why people often regain weight after losing it and whether hormones play a role. This study focuses on children aged 11 to 15 years old with a BMI above 30 or in the 95th percentile. The research includes two parts: an 8-week meal replacement period and a follow-up period to assess changes in fat mass and hormone levels. Participants will follow a meal replacement therapy for 8 weeks, consuming shakes for breakfast and lunch and a calorie-controlled frozen meal for dinner along with two servings of fruit and three servings of vegetables daily. The study provides the shakes and frozen meals, while participants supply the fruits and vegetables. Behavioral and lifestyle counseling is given every two weeks throughout the study, delivered at in-person visits and remotely when needed. The study lasts up to 35 weeks and includes 10 in-person visits and 13 remote visits via phone or Zoom. Participants will keep dietary logs to track meal compliance. Researchers will measure fat mass regain, changes in ghrelin, and gastric inhibitory polypeptide after 17 weeks. The study also monitors adherence to the diet and behavior changes during the entire participation period.
CONDITIONS
Brief Title
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 11 to less than 16 years old
- BMI greater than 30 kg/m² or at the 95th BMI percentile
- Tanner stage 2, 3, or 4
You will not qualify if you...
- Tanner stage 1 or 5
- Prior bariatric surgery
- Use of certain anti-obesity medications within 3 months before enrollment
- Diagnosis of monogenic or hypothalamic obesity
- Polycystic ovary syndrome diagnosed by a physician
- Pregnancy or planned pregnancy
- Current use of supplemental hormones
- Diagnosed eating disorder such as anorexia nervosa, bulimia, or binge eating disorder
- Type 1 or 2 diabetes
- Treatment with growth hormones
- Thyroid disease or problem
- Cancer diagnosis within the last 10 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants follow an 8-week meal replacement therapy to reduce BMI by more than 5%, including prescribed shakes and meals for breakfast, lunch, and dinner. They also receive lifestyle and behavioral modification counseling every 2 weeks throughout the entire study via in-person and virtual visits.
In-person and virtual visits every 2 weeks
Duration - Up to 9 weeks after treatment (total 17 weeks from start)
Participants continue lifestyle and behavioral modification counseling every 2 weeks while being observed for changes in fat mass regain and hormone levels up to 17 weeks after initial treatment.
In-person and virtual visits every 2 weeks
Trial Site Locations
Total: 1 location
1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
J
Justin Ryder, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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