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Overweight and Obesity in Adolescents - Sleep Behavioral Intervention

RecruitingNAAges 13 Years - 17 YearsAllUniversity of Beira Interior
NCT07255274 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 obesit

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sleep Behavioral Intervention
  • Standard Obesity Treatment
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Where

2 sites
Unidade Local de Saúde Cova da Beira
Covilha, Portugal
Hospital CUF Porto
Porto, Portugal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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