NCT07255274 Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
| NCT ID | NCT07255274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Beira Interior |
| Condition | Obesity and Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2025-06-03 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07255274 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Obesity and Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07255274 currently recruiting?
Yes, NCT07255274 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Beira Interior to inquire about joining.
Where is the NCT07255274 trial being conducted?
This trial is being conducted at Covilha, Portugal, Porto, Portugal.
Who is sponsoring the NCT07255274 clinical trial?
NCT07255274 is sponsored by University of Beira Interior. The trial plans to enroll 126 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.