Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-15
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

11 to less than 16 years old

BMI > 30 kg/m² or 95th BMI percentile

Tanner stage 2, 3, or 4

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Meal replacement and lifestyle modification

    Other intervention

    Meal replacement and lifestyle modification

Treatment groups

260 Participants
are divided into 1 treatment group
Group A: Meal Replacement and Lifestyle TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)

We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.

Time frame
17 weeks.
2

Change in ghrelin

We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.

Time frame
17 weeks.
3

Change in gastric inhibitory polypeptide

We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.

Time frame
17 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.