Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 15
Healthy Volunteers: f
View:

• 11 to less than 16 years old

• BMI \> 30 kg/m\^2 or 95th BMI percentile

• Tanner stage 2, 3, or 4

Locations
United States
Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Contact Information
Primary
Justin Ryder, PhD
jryder@luriechildrens.org
3148826838
Time Frame
Start Date: 2023-08-26
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 260
Treatments
Experimental: Meal Replacement and Lifestyle Therapy
Participants in this study will have an 8-week meal replacement therapy period in which they are asked to reduce their BMI by 5% by following a prescribed eating regimen consisting of meal replacement shakes and/or frozen meals for breakfast and lunch. For dinner they will consume a pre-packaged frozen entree to be consumed with two servings of fruit and three servings of vegetables per day. Participants will also have lifestyle/behavioral modification counseling every 2 weeks throughout the entire study.
Related Therapeutic Areas
Sponsors
Leads: Ann & Robert H Lurie Children's Hospital of Chicago

This content was sourced from clinicaltrials.gov