Actively Recruiting
Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
Led by University of Beira Interior · Updated on 2025-12-01
126
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 2) or obesity (BMI z-score > 2), according to WHO criteria
- Sleep deprivation or poor sleep quality, based on the initial screening questionnaire
You will not qualify if you...
- Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes)
- Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep
- Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Unidade Local de Saúde Cova da Beira
Covilha, Portugal
Actively Recruiting
2
Hospital CUF Porto
Porto, Portugal
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here