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Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
11 Years to 15 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 13 visits
  • Time periods mentioned: 35 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at why young people regain weight after weight loss and whether hormones play a role. It is for youth ages 11 to 15 with obesity who are going through puberty. Participants follow a meal replacement plan, then have follow-up visits, for up to 35 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 11 to 15.
  • Have a BMI over 30 or at the 95th percentile for age. BMI is a measure of weight compared with height.
  • Be in stages 2, 3, or 4 of puberty, when the body changes toward adulthood.

Who can't join

  • Have not started puberty or have finished puberty.
  • Have had weight-loss surgery.
  • Use or have used these weight-loss medicines within 3 months before joining: orlistat, metformin, phentermine, topiramate, phentermine/topiramate, liraglutide, or naltrexone/bupropion. Naltrexone or bupropion used alone does not rule you out.
  • Have obesity caused by a change in one gene or by a problem in the hypothalamus, a part of the brain.
  • Have doctor-diagnosed polycystic ovary syndrome, a hormone condition; are pregnant; or plan to become pregnant.
  • Have type 1 or type 2 diabetes or a thyroid problem, or currently take extra hormones or receive growth hormone treatment.
  • Have a diagnosed eating disorder: anorexia nervosa, bulimia, or binge eating disorder.
  • Have had cancer in the past 10 years.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

IL