Overweight and Obesity in Adolescents - Sleep Behavioral Intervention

NCT07255274 | Recruiting

• 1 other identifier: TID 101794088
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity and Overweight; Sleep Disorder

Keywords

Obesity; Sleep; Behavioral intervention; Adolescents

Outcome Measures

Primary Outcomes (4)

• BMI z-score at 6 months

  Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2. Then, BMI z-score will be calculated by WHO Anthroplus software 3.2.2.

  6 months

• BMI at 6 months

  Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2.

  6 months

• Fat mass percentage at 6 months

  Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). Fat mass percentage (%FM) assessed using bioelectrical impedance analysis with InBody 270®.

  6 months

• Fat-free mass index at 6 months

  Variation between Visit 1 (baseline) and Visit 4 (end of the intervention). FFMI (kg/ m2) calculated using FFM (in kilograms) and height (in meters).

  6 months

Secondary Outcomes (29)

• Participants achieving a BMI reduction ≥5%

  6 months and 12 months

• Participants achieving a BMI reduction ≥10%

  6 months and 12 months

• Change in Waist circumference centile

  6 months and 12 months

• Fat mass percentage at 12 months

  12 months

• Fat-free mass index at 12 months

  12 months

Other Outcomes (2)

• Tryptophan pathway metabolites measurement

  6 months

• Leptin and ghrelin levels

  6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects.

Other: Standard Obesity Treatment

Intervention group

EXPERIMENTAL

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.

Behavioral: Sleep Behavioral Intervention; Other: Standard Obesity Treatment

Interventions

Sleep Behavioral Intervention BEHAVIORAL

Our research team, composed by pediatricians with experience in Obesity and Adolescent Medicine, and clinical psychologists with experience in Sleep, Obesity, and Cognitive Behavioral Therapy (CBT), developed a specific manual for this project: "Behavioral Sleep Intervention - SLEEP-OB - Therapist Support Manual." The manual was adapted based on CBT models for adults and adolescents with insomnia and on CBT for adolescents with other sleep disorders and comorbidities, namely obesity. The behavioral intervention aims to promote sustainable changes in sleep. It includes behavioral strategies (such as sleep restriction, stimulus control), cognitive strategies (cognitive reappraisal/restructuring, cognitive control, paradoxical intention), mixed strategies (sleep education/hygiene, relaxation), self-monitoring, and problem identification and resolution. The intervention will take place over six months, with a total of seven sessions (in-person and by video call).

Also known as: Sleep intervention, Cognitive Behavioral Therapy for sleep disorders

Intervention group

Standard Obesity Treatment OTHER

Standard obesity treatment for pediatric obesity according to international guidelines. It comprises pediatric appointments, and usually also nutrition and nursing appointments, every 2 to 3 months. These appointments include an anthropometric evaluation, physical examination and personalized multicomponent behavioral intervention with focus on nutrition, physical activity/sedentary behavior and other lifestyle recommendations. This standard intervention is common for both groups/arms.

Also known as: treatment as usual

Control group; Intervention group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Beira Interior: lead

Study Sites (2)

Unidade Local de Saúde Cova da Beira

Covilha, Portugal

RECRUITING

Hospital CUF Porto

Porto, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Sleep Wake Disorders

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization is performed by a researcher not involved in data management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Open-Label Randomized Clinical Study with a Behavioral Intervention

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: December 1, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: June 2026 to June 2027
• Access Criteria: The data supporting the findings of this study will be available upon request from the corresponding author. Each request will be reviewed by the research team and the Ethics Committees that approved the study to ensure compliance with ethical standards.

Locations

PT (2)