Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT05125822
Status
Recruiting
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Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
11 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Meal replacement and lifestyle modification — OTHER
    Meal replacement and lifestyle modification

Study Details

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.

Key Dates

Start date
Aug 26, 2023
Status verified
May 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Change in fat mass regain after initial weight loss with meal replacement therapy (MRT) [ Time Frame: 17 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H Lurie Children's Hospital of ChicagoChicagoIllinois60611
Justin R Ryder
[email protected]
3148826838
Justin Ryder, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Ann & Robert H Lurie Children's Hospital of Chicago· Chicago, IL

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