Understanding weight regain in youth with obesity
Official title: Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
Run by Ann & Robert H Lurie Children's Hospital of Chicago · NCT05125822 · Data updated 2026-11-12
This study is testing how meal replacement therapy and counseling can help young people who have lost weight understand and prevent regaining it by looking at the role of hormones.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 11 Years to 15 Years |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | August 26, 2023 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT05125822 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are youth aged 11 to less than 16 years with a BMI over 30 kg/m² or at the 95th percentile.
✕Probably not a fit
Patients with certain medical conditions, such as diagnosed eating disorders or those who have had prior bariatric surgery, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the reasons behind weight regain in youth who have lost weight, focusing on the role of hormones. Participants will undergo an 8-week meal replacement therapy, consuming shakes and frozen meals while adhering to a calorie-controlled diet. They will also receive bi-weekly lifestyle and behavioral modification counseling to support their weight loss efforts. The study will track compliance through dietary logs and assess the effectiveness of the interventions over a 35-week period.
Why it matters
Potential benefit: If successful, this study could provide insights into effective weight management strategies for youth with obesity.
How similar studies have gone: Other studies have shown success in using meal replacement and behavioral modification for weight management, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Justin Ryder, PhD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Justin Ryder, PhD
- Email: jryder@luriechildrens.org
- Phone: 3148826838
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.