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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Meal replacement and lifestyle modification
Other interventionMeal replacement and lifestyle modification
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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