Study on How Weight Changes in Youth With Obesity Using Meal Replacement and Lifestyle Therapy

What this Trial Is About

Researchers are studying weight regain in youth with obesity to understand why people often regain weight after losing it and whether hormones play a role. This study focuses on children aged 11 to 15 years old with a BMI above 30 or in the 95th percentile. The research includes two parts an 8-week meal replacement period and a follow-up period to assess changes in fat mass and hormone levels. Participants will follow a meal replacement therapy for 8 weeks, consuming shakes for breakfast and lunch and a calorie-controlled frozen meal for dinner along with two servings of fruit and three servings of vegetables daily. The study provides the shakes and frozen meals, while participants supply the fruits and vegetables. Behavioral and lifestyle counseling is given every two weeks throughout the study, delivered at in-person visits and remotely when needed. The study lasts up to 35 weeks and includes 10 in-person visits and 13 remote visits via phone or Zoom. Participants will keep dietary logs to track meal compliance. Researchers will measure fat mass regain, changes in ghrelin, and gastric inhibitory polypeptide after 17 weeks. The study also monitors adherence to the diet and behavior changes during the entire participation period.

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity