NCT05125822 Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
| NCT ID | NCT05125822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Childhood Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2023-08-26 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2023-08-26 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Justin Ryder, PhD
PRINCIPAL INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Frequently Asked Questions
Who can join the NCT05125822 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 15 Years, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05125822 currently recruiting?
Yes, NCT05125822 is actively recruiting participants. Contact the research team at jryder@luriechildrens.org for enrollment information.
Where is the NCT05125822 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05125822 clinical trial?
NCT05125822 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Justin Ryder, PhD at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 260 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.