Overweight and Obesity in Adolescents - Sleep Behavioral Intervention
NCT ID: NCT07255274
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2025-06-03
2026-12-31
Brief Summary
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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.
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Detailed Description
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In addition to the primary aim, the researchers will evaluate several secondary outcomes, including the efficacy of the intervention in relation to: cardiometabolic risk, sleep patterns, eating patterns, physical activity level, emotional well-being/self-compassion, quality of life, leptin and ghrelin levels, and tryptophan and melatonin metabolism.
Throughout the study period, all medical consultations will include standard multicomponent behavioral intervention. The sleep behavioral intervention will be conducted by psychologists.
The intervention consists of seven cognitive-behavioral therapy (CBT) sessions over six months, focusing on sleep hygiene, self-monitoring, stimulus control, cognitive therapy, and relaxation techniques.
Data collection and analysis will include objective sleep assessment using actigraphy and a level 3 ambulatory sleep study. Blood samples will be collected at baseline, six months, and twelve months to analyze metabolic markers. From the samples collected at months 0 and 6, a portion will be appropriately stored for additional analysis at an external facility to quantify leptin, ghrelin, and tryptophan pathway metabolites.
Anthropometric and clinical assessments will include measurements of body mass index (BMI), waist circumference, body composition, and blood pressure. Validated questionnaires will be used to evaluate sleep patterns, eating behaviors, physical activity, quality of life, emotional well-being, and self-compassion.
It is anticipated that the sleep behavioral intervention combined with standard treatment will be more effective than standard treatment alone not only in reducing adiposity, but also in improving cardiometabolic risk, sleep patterns, eating patterns, physical activity, emotional well-being, self-compassion, and in regulating hormonal and metabolic pathways including ghrelin, leptin, and the tryptophan-melatonin axis, as outlined in the study hypotheses
The study also aims to clarify the role of ghrelin and leptin levels, as well as the tryptophan pathway, in the interaction between sleep and obesity and in the effects of the intervention
Emotional well-being and self-compassion are expected to mediate the response to obesity intervention and the sleep-obesity relationship, potentially influencing or influenced by the tryptophan metabolic pathway, particularly serotonin levels.
By deepening the knowledge about the relationship between sleep and obesity, this research may contribute to optimize interventions for pediatric obesity, which would have an unequivocal positive impact.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects.
Standard Obesity Treatment
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.
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.
Sleep Behavioral Intervention
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).
Standard Obesity Treatment
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.
Interventions
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Sleep Behavioral Intervention
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).
Standard Obesity Treatment
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
17 Years
ALL
No
Sponsors
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University of Beira Interior
OTHER
Responsible Party
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ana sofia rodrigues ferreira
PhD student
Locations
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Unidade Local de Saúde Cova da Beira
Covilha, , Portugal
Hospital CUF Porto
Porto, , Portugal
Countries
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Facility Contacts
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Other Identifiers
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TID 101794088
Identifier Type: -
Identifier Source: org_study_id
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