NCT07255274

Overweight and Obesity in Adolescents - Sleep Behavioral Intervention

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: University of Beira Interior · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Sleep plays a crucial role in energy balance, alongside diet and physical activity. Research has linked poor sleep quality and short sleep duration to obesity and cardiometabolic risk, such as insulin resistance and hypertension. The nature of this association is complex, and several mechanims have been suggested. Scientific evidence suggests that sleep interventions may provide additional benefits in optimizing the effectiveness of overweight/obesity treatment in pediatric populations. Although some studies have explored this hypothesis, methodological heterogeneity hampers clear interpretation of the results. The main goal of this clinical trial is is to evaluate the efficacy of a sleep behavioral intervention, combined with standard obesity treatment, in reducing adiposity (measured by BMI z-score, fat mass percentage, or fat-free mass index) in adolescents with overweight or obesity. This randomized controlled trial will compare a control group receiving treatment as usual (or standard obesity treatment) with an intervention group receiving treatment as usual plus a sleep behavioral intervention. Participants will be randomized into two groups: intervention and control. Throughout the study period, all medical consultations will include standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle factors. The sleep-focused intervention will be delivered by psychologists. Participants will attend clinic visits every two months during the 6-month intervention period, and every three months during the subsequent 6-month follow-up period.

Detailed description

A randomized controlled trial (open-label, behavioral intervention) will be conducted at ULS Cova da Beira and Hospital CUF Porto, enrolling 126 adolescents (ages 13-17) diagnosed with overweight or obesity and poor sleep quality. Participants will be randomized into two groups: the intervention group (sleep behavioral intervention plus treatment as usual) and the control group (treatment as usual). In addition to the primary aim, the researchers will evaluate several secondary outcomes, including the efficacy of the intervention in relation to: cardiometabolic risk, sleep patterns, eating patterns, physical activity level, emotional well-being/self-compassion, quality of life, leptin and ghrelin levels, and tryptophan and melatonin metabolism. Throughout the study period, all medical consultations will include standard multicomponent behavioral intervention. The sleep behavioral intervention will be conducted by psychologists. The intervention consists of seven cognitive-behavioral therapy (CBT) sessions over six months, focusing on sleep hygiene, self-monitoring, stimulus control, cognitive therapy, and relaxation techniques. Data collection and analysis will include objective sleep assessment using actigraphy and a level 3 ambulatory sleep study. Blood samples will be collected at baseline, six months, and twelve months to analyze metabolic markers. From the samples collected at months 0 and 6, a portion will be appropriately stored for additional analysis at an external facility to quantify leptin, ghrelin, and tryptophan pathway metabolites. Anthropometric and clinical assessments will include measurements of body mass index (BMI), waist circumference, body composition, and blood pressure. Validated questionnaires will be used to evaluate sleep patterns, eating behaviors, physical activity, quality of life, emotional well-being, and self-compassion. It is anticipated that the sleep behavioral intervention combined with standard treatment will be more effective than standard treatment alone not only in reducing adiposity, but also in improving cardiometabolic risk, sleep patterns, eating patterns, physical activity, emotional well-being, self-compassion, and in regulating hormonal and metabolic pathways including ghrelin, leptin, and the tryptophan-melatonin axis, as outlined in the study hypotheses The study also aims to clarify the role of ghrelin and leptin levels, as well as the tryptophan pathway, in the interaction between sleep and obesity and in the effects of the intervention Emotional well-being and self-compassion are expected to mediate the response to obesity intervention and the sleep-obesity relationship, potentially influencing or influenced by the tryptophan metabolic pathway, particularly serotonin levels. By deepening the knowledge about the relationship between sleep and obesity, this research may contribute to optimize interventions for pediatric obesity, which would have an unequivocal positive impact.

Conditions

• Obesity and Overweight
• Sleep Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Behavioral Intervention	Our research team, composed by pediatricians with experience in Obesity and Adolescent Medicine, and clinical psychologists with experience in Sleep, Obesity, and Cognitive Behavioral Therapy (CBT), developed a specific manual for this project: "Behavioral Sleep Intervention - SLEEP-OB - Therapist Support Manual." The manual was adapted based on CBT models for adults and adolescents with insomnia and on CBT for adolescents with other sleep disorders and comorbidities, namely obesity. The behavioral intervention aims to promote sustainable changes in sleep. It includes behavioral strategies (such as sleep restriction, stimulus control), cognitive strategies (cognitive reappraisal/restructuring, cognitive control, paradoxical intention), mixed strategies (sleep education/hygiene, relaxation), self-monitoring, and problem identification and resolution. The intervention will take place over six months, with a total of seven sessions (in-person and by video call).
OTHER	Standard Obesity Treatment	Standard obesity treatment for pediatric obesity according to international guidelines. It comprises pediatric appointments, and usually also nutrition and nursing appointments, every 2 to 3 months. These appointments include an anthropometric evaluation, physical examination and personalized multicomponent behavioral intervention with focus on nutrition, physical activity/sedentary behavior and other lifestyle recommendations. This standard intervention is common for both groups/arms.

Timeline

• Start date: 2025-06-03
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

2 sites across 1 country: Portugal