NCT05125822Recruiting
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 8 Nov 2021
- Start date
- 26 Aug 2023
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Diseases
- Obesity
- NCT number
- NCT05125822
What you commit to
- Study type: Interventional
- Planned participants: 260
- From 26 Aug 2023 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Treatment with growth hormones
Other illness
- Polycystic ovary syndrome (diagnosed by a physician)
- Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder
- Type 1 or 2 diabetes
- Thyroid disease/problem
- Has had cancer in the last 10 years
Other
- Tanner stage 1 and 5
- Monogenic and hypothalamic obesity
- Pregnancy or planned pregnancy
- Current use of supplemental hormones
Who the study is looking for
- 11 to less than 16 years old
- BMI \> 30 kg/m\^2 or 95th BMI percentile
- Tanner stage 2, 3, or 4
Age in the registry: 11 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.