Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Unidade Local de Saúde Cova da Beira
RECRUITING
Covilha
Hospital CUF Porto
NOT_YET_RECRUITING
Porto
Time Frame
Start Date: 2025-06-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 126
Treatments
Active_comparator: Control group
Standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects.
Experimental: Intervention group
Standard intervention plus sleep-focused intervention. The sleep intervention will be conducted by psychologists. These monthly sessions, delivered in person or via video call, will be scheduled on the same day as the medical consultation whenever possible. The session planning and objectives are outlined in the study protocol.
Sponsors
Leads: University of Beira Interior

This content was sourced from clinicaltrials.gov