NCT07255274Recruiting
Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 14 Jun 2025
- Start date
- 3 Jun 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Beira Interior
- Diseases
- Obesity
- NCT number
- NCT07255274
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 3 Jun 2025 to the primary completion date, 30 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep.
Other illness
- Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep;
Other
- Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes);
Who the study is looking for
- Informed consent from legal guardians and assent/consent from the adolescent;
- Age between 13 and 17 years at the time of consent;
- Diagnosis of overweight (BMI z-score \> 1 and ≤ 2) or obesity (BMI z-score \> 2), according to WHO criteria;
- Sleep deprivation or poor sleep quality, based on the initial screening questionnaire.
Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unidade Local de Saúde Cova da Beira Coordinator of this site? Confirm its status | Covilha | Portugal | Recruiting |
| Hospital CUF Porto Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.