Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB

What this Trial Is About

Researchers are investigating how a sleep behavioral intervention combined with standard obesity treatment affects adolescents aged 13 to 17 who have overweight or obesity with poor sleep quality. The study aims to better understand how improving sleep may help reduce body fat and improve related health risks like insulin resistance and hypertension. This trial compares usual obesity treatment alone to usual treatment plus a sleep-focused behavioral therapy delivered by psychologists. Participants will be randomly assigned to either the control group receiving standard obesity care or the intervention group receiving standard care plus seven cognitive-behavioral therapy sessions over six months. These sessions focus on improving sleep hygiene, self-monitoring, stimulus control, cognitive therapy, and relaxation techniques. Medical visits occur every two months during the six-month intervention and every three months during a six-month follow-up period. During the study, participants will undergo assessments including body measurements BMI, waist circumference, fat mass, sleep evaluations using actigraphy and ambulatory sleep studies, blood tests for metabolic markers, and questionnaires on sleep, eating habits, physical activity, emotional well-being, and quality of life. The primary outcome is changes in BMI z-score and body composition at six months. Secondary outcomes include cardiometabolic risk factors, hormonal levels, and emotional measures, with safety and progress monitored throughout the 12-month study period.

Overweight and Obesity in Adolescents - Sleep Behavioral Intervention