Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

This study aims to understand why young people who lose weight often regain it when they return to a regular diet, and if hormones play a role. Participants aged 11 to 15 with a BMI over 30 (obesity) will take part. You cannot join if you've had bariatric surgery or recently used anti-obesity medications. The study involves an 8-week period of meal replacement therapy (shakes and frozen meals) and lifestyle counseling, followed by a longer observation period. Researchers will measure changes in fat regain and hormones like ghrelin and gastric inhibitory polypeptide after 17 weeks to see if the intervention is successful. The study plans to enroll 260 participants, but its current status is unclear.

Study design
This is an interventional study with 260 planned participants. It involves a meal replacement and lifestyle modification intervention.
What's involved
You would participate for up to 35 weeks, including an 8-week meal replacement period and bi-weekly lifestyle counseling sessions.
Compensation
Not stated in the trial record.
Follow-up
Changes in fat mass regain and hormones are measured at 17 weeks after initial weight loss.

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NCT05125822

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Recruiting
NAAges 11–15InterventionalBasic science
Ann & Robert H Lurie Children's Hospital of Chicago
~260 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Meal replacement and lifestyle modification

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)
Measured over 17 weeks.
+2 more outcomes measured
Childhood Obesity
1 sites across 1 states
Illinois1
  • Justin Ryder, PhD · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago

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Eligibility criteria

Inclusion

11 to less than 16 years old
BMI \> 30 kg/m\^2 or 95th BMI percentile
Tanner stage 2, 3, or 4

Exclusion

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
  • Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)17 weeks.

    We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.

  • Change in ghrelin17 weeks.

    We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.

  • Change in gastric inhibitory polypeptide17 weeks

    We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.