Ann & Robert H Lurie Children's Hospital of Chicago
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.
Individuals who are found to be eligible to participate will have two study interventions: An 8-week meal replacement therapy period in which they are asked to reduce their BMI by \>5%. Participants will be asked to strictly follow the individually-prescribed eating regimen which will include meal replacement shakes and/or frozen meals to be used for breakfast and lunch. For dinner, the study will provide pre-packaged frozen entrée meals to be consumed with two servings of fruit and three servings of vegetables per day. Meal replacement compliance will be assessed by requiring participants to…
Inclusion Criteria: * 11 to less than 16 years old * BMI \> 30 kg/m\^2 or 95th BMI percentile * Tanner stage 2, 3, or 4 Exclusion Criteria: * 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 * Polycystic ovary syndrome (diagnosed by a physician) * Pregnancy or pl…
Meal replacement and lifestyle modification
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