Adding a sleep program to obesity treatment in teenagers with overweight
Tests a sleep behavioral program alongside usual care in teenagers with overweight or obesity.
Plain-language title generated from the registry record
Registry title: Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
Key facts
- Where
- Covilha and Porto, PortugalSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 13 and 17 years old?
Source: NCT07255274, who can take part
Where in Portugal
- Unidade Local de Saúde Cova da BeiraCovilha, PortugalTaking people
- Hospital CUF PortoPorto, PortugalNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Beira Interior
- Trial code
- NCT07255274
- Record updated
- 1 December 2025
- Original description
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.Read full original descriptionShow less
Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
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.
Inclusion: 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.
Exclusion: Current treatment with selective serotonin reuptake inhibitors (SSRIs) or other medications affecting sleep; Comorbid psychiatric or neurological disorders (e.g., epilepsy, autism spectrum disorder) that affect sleep; Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes).