Sleep behavioral program for adolescents with overweight or obesity
Official title: Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
Run by University of Beira Interior · NCT07255274 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 13 Years to 17 Years |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | University of Beira Interior Academic / other |
| Locations | 2 sites (Covilha and 1 other locations) |
| Status | Recruiting |
| Started | June 3, 2025 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT07255274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Unidade Local de Saúde Cova da Beira
Covilha, Portugal Recruiting -
Hospital CUF Porto
Porto, Portugal Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.