Sleep behavioral program for adolescents with overweight or obesity
Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
This trial will test whether adding a sleep-focused behavioral program to usual weight treatment helps teens (13–17) with overweight or obesity who have poor sleep improve body composition and health markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | University of Beira Interior Academic / other |
| Locations | 2 sites (Covilha and 1 other locations) |
| Trial ID | NCT07255274 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label behavioral trial at two Portuguese sites that will enroll 126 adolescents (ages 13–17) with overweight or obesity and poor sleep quality. Participants are randomly assigned to receive seven CBT-based sleep sessions over six months plus standard multicomponent obesity treatment, or standard treatment alone. Primary outcomes focus on adiposity (BMI z-score, fat mass percentage, fat-free mass index), with secondary outcomes including cardiometabolic risk, objective sleep measures (actigraphy and level 3 ambulatory study), eating patterns, physical activity, emotional well-being, quality of life, and metabolic hormones. Blood samples will be collected at baseline, 6 months, and 12 months, and some samples will be stored for additional analyses.
Who should consider this trial
Good fit: Adolescents aged 13–17 with overweight or obesity by WHO BMI z-score criteria who report poor sleep quality and whose guardians provide consent are the intended participants.
Not a fit: Those with secondary causes of obesity, major psychiatric or neurological disorders affecting sleep, or who are taking SSRIs or other medications that affect sleep are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, adding a sleep behavioral program could improve body composition and reduce cardiometabolic risk in adolescents with overweight or obesity.
How similar studies have performed: Some prior small studies have suggested sleep interventions may help weight-related outcomes in youth, but results are mixed and methodological differences limit definitive conclusions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed consent from legal guardians and assent/consent from the adolescent; 2. Age between 13 and 17 years at the time of consent; 3. Diagnosis of overweight (BMI z-score \> 1 and ≤ 2) or obesity (BMI z-score \> 2), according to WHO criteria; 4. Sleep deprivation or poor sleep quality, based on the initial screening questionnaire. Exclusion Criteria: 1. Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes); 2. Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep; 3. Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep.
Where this trial is running
Covilha and 1 other locations
- Unidade Local de Saúde Cova da Beira — Covilha, Portugal (Recruiting)
- Hospital CUF Porto — Porto, Portugal (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.