Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Childhood Obesity

🗓️ Study Start (Actual) 26 August 2023

🗓️ Primary Completion (Estimated) 1 May 2026

✅ Study Completion (Estimated) 1 January 2028

👥 Enrollment (Estimated) 260

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 11 Years to 15 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 8 November 2021
First Submitted that Met QC Criteria 8 November 2021
First Posted 18 November 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 30 August 2023
Last Update Posted 31 August 2023
Last Verified January 2023