Overweight and Obesity in Adolescents - Sleep Behavioral Intervention (SLEEP-OB)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Obesity and Overweight
• Intervention / Treatment: Other: Standard Obesity Treatment; Behavioral: Sleep Behavioral Intervention

Detailed Description

A randomized controlled trial (open-label, behavioral intervention) will be conducted at ULS Cova da Beira and Hospital CUF Porto, enrolling 126 adolescents (ages 13-17) diagnosed with overweight or obesity and poor sleep quality. Participants will be randomized into two groups: the intervention group (sleep behavioral intervention plus treatment as usual) and the control group (treatment as usual).

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Covilha, Portugal
    • Recruiting
    • Unidade Local de Saúde Cova da Beira
    • Contact: Sofia Ferreira, MD; Phone Number: +351275330000; Email: ana.sofia.ferreira@ubi.pt
    • Contact: Arminda Jorge, PhD in Medicine; Email: ajorge@fcsaude.ubi.pt
    • Principal Investigator: Sofia Ferreira, Medical Doctor
    • Sub-Investigator: Marta Rodrigues, Medical Doctor, Master degree
    • Sub-Investigator: Nuno Lourenço, Medical Doctor, Master degree
    • Sub-Investigator: Arminda Jorge, PhD in Medicine
    • Sub-Investigator: Ana Serra, Master in Psychology
  • Porto, Portugal
    • Not yet recruiting
    • Hospital CUF Porto
    • Contact: Carla Rêgo, PhD in Medicine; Email: carlambssrego@gmail.com
    • Principal Investigator: Carla Rêgo, PhD in Medicine
    • Sub-Investigator: Carla Laranjeira, Medical Doctor
    • Sub-Investigator: Sofia Ramalho, PhD in Psychology
    • Sub-Investigator: Margarida Gouveia, Master student in Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed consent from legal guardians and assent/consent from the adolescent;
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:

1. Secondary obesity (e.g., hypothalamic, genetic, or endocrine causes);
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects.	Other: 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 Names: treatment as usual
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.	Other: 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 Names: treatment as usual; Behavioral: 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).; Other Names: Sleep intervention; Cognitive Behavioral Therapy for sleep disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants achieving a BMI reduction ≥5%	Percentage of participants achieving a BMI reduction ≥5% between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Participants achieving a BMI reduction ≥10%	Percentage of participants achieving a BMI reduction ≥10% between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in Waist circumference centile	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6. waist circumference in centimeters, and centiles according to Sharma AK, et al. Pediatr Res. 2015.	6 months and 12 months
Fat mass percentage at 12 months	Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). Fat mass percentage (%FM) assessed using bioelectrical impedance analysis with InBody 270®.	12 months
Fat-free mass index at 12 months	Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). FFMI (kg/ m2) calculated using FFM (in kilograms) and height (in meters).	12 months
BMI z-score at 12 months	Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). 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.	12 months
BMI at 12 months	Variation between Visit 1 (baseline) and Visit 6 (end of the follow-up). Weight (in kilograms) and height (in meters) will be used to calculate BMI in kg/m2.	12 months
Change in Waist-to-height Ratio	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in C-reactive protein	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in Fasting Lipid: Total Cholesterol	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in Fasting Lipid: LDL-cholesterol	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in Fasting Lipid: HDL-cholesterol	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in Fasting Lipid: Triglycerides	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in centiles of Systolic and Diastolic Blood Pressure	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6. Blood pressure measured and centiles according to the American Academy of Pediatrics.	6 months and 12 months
Change in HbA1c	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.	6 months and 12 months
Change in Glycaemic Category	Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6. Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" 2 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: fasting plasma glucose (FPG) <100 mg/dL and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes (T2DM): FPG ≥126 mg/dL and/or HbA1c ≥6.5%	6 months and 12 months
Change in HOMA-B	Variation between Visit 1 and Visit 4 and between Visit and Visit 6. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).	6 months and 12 months
Change in HOMA-IR	Variation between Visit 1 and Visit 4 and between Visit and Visit 6. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. R	6 months and 12 months
Change in Continuous metabolic syndrome score	Variation between Visit 1 and Visit 4 and between Visit and Visit 6. Calculation according to Vukovic R, et al. PLoS One. 2017 Dec 6;12(12):e0189232.	6 months and 12 months
Change in Sleep quality	Sleep quality assessed by the Pittsburgh Sleep Quality Index, at Visit 1and Visit 4, and at Visit 6.	6 months and 12 months
Change in sleep quality - actigrafy	Sleep quality assessed by actigraphy and sleep diary, at Visit 1and Visit 4.	6 months
Change in Respiratory Sleep disorder	Respiratory sleep disorder assessed by the Pediatric sleep questionnaire at Visit 1and Visit 4.	6 months
Change in Diet Quality	Mediterranean Diet Quality assessed with KIDMED questionnaire, at Visit 1 and Visit 4.	6 months
Change in Eating behavior	MEating behavior assessed with Eating Attitudes Test questionnaire, at Visit 1 and Visit 4.	6 months
Change in emotional well-being	At Visit 1 and Visit 4: Emotional well-being assessed through the WHO-5.	6 months
Change in Quality of life	At Visit 1 and Visit 4: Quality of life evaluated with the KIDSCREEN 52 questionnaire.	6 months
Change in self-compassion	At Visit 1 and Visit 4: Self-compassion evaluated with the Self-Compassion Scale for adolescents.	6 months
Change in Physical activity	Physical activity assessed with International Physical Activity Questionnaire for Adolescents, at Visit 1 and Visit 4.	6 months
Change in Physical activity - actigraphy	Physical activity assessed by actigraphy, at Visit 1 and Visit 4.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tryptophan pathway metabolites measurement	Levels of tryptophan, kynurenine, serotonin, and melatonin in plasma samples, by metabolomic analysis/ liquid chromatography, at baseline (Visit 1) and after the Intervention (Visit 4).	6 months
Leptin and ghrelin levels	Levels of leptin and ghrelin will be measured in plasma samples using enzyme-linked immunosorbent assay (ELISA) at baseline (Visit 1) and after the intervention (Visit 4).	6 months

Collaborators and Investigators

• Sponsor: University of Beira Interior

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 14, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Obesity; Sleep; Behavioral intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Sleep Wake Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Therapeutics
• Other Study ID Numbers: TID 101794088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data may be shared upon request, provided that all identifying information is removed to safeguard participant anonymity. This process upholds the confidentiality and privacy of participants, fully complying with ethical and legal standards for data protection.
• IPD Sharing Time Frame: June 2026 to June 2027
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No