Actively Recruiting

Phase Not Applicable
Age: 11Years - 15Years
All Genders
NCT05125822

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-08-22

260

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Who Can Participate

Age: 11Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 11 and less than 16 years
  • Body mass index (BMI) over 30 kg/m² or at the 95th percentile or higher
  • Tanner stage 2, 3, or 4
Not Eligible

You will not qualify if you...

  • Tanner stage 1 or 5
  • Previous bariatric surgery
  • Use of anti-obesity medications like orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, or combination naltrexone/bupropion within 3 months before enrollment
  • Monogenic or hypothalamic obesity
  • Diagnosed polycystic ovary syndrome
  • Pregnancy or planning to become pregnant
  • Current use of supplemental hormones
  • Diagnosed eating disorders including anorexia nervosa, bulimia, or binge eating disorder
  • Type 1 or type 2 diabetes
  • Treatment with growth hormones
  • Thyroid disease or problems
  • Cancer diagnosis within the past 10 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

J

Justin Ryder, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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