No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
11 – 15
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
260 (estimated)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Other
Who this trial is looking for
This trial is looking for young people aged 11 to 15 who are struggling with obesity. Participants will follow a special meal plan that includes drinking shakes and eating controlled meals for around 35 weeks and will have regular check-ins with the study team.
Are You a Good Fit for This Trial?
Must not be takingOrlistatMetforminPhentermineTopiramateLiraglutideNaltrexone
Rules you outMonogenic obesityHypothalamic obesityThyroid diseaseCancer in the last 10 years
You may be able to join if
I am between 11 and 15 years old.
I have a BMI over 30 or am in the 95th BMI percentile.
I am at Tanner stage 2, 3, or 4.
You may not be able to join if
I am at Tanner stage 1 or 5.
I have had weight loss surgery before.
I have used anti-obesity medications in the last 3 months.
I have polycystic ovary syndrome.
I am pregnant or planning to be pregnant.
I currently use supplemental hormones.
I have a diagnosed eating disorder.
I have type 1 or 2 diabetes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ea…
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.
Trial Locations
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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,…
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
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