Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
NCT07255274

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

Age: 13Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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