Overweight and Obesity in Adolescents - Sleep Behavioral Intervention

ConditionsObesity and Overweight Sleep Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-17

SponsorUniversity of Beira Interior

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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).
Standard Obesity Treatment
Other intervention
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.

Treatment groups

126 Participants

are divided into 2 treatment groups

Group A: Control groupActive comparator 1 intervention

Group B: Intervention groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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®.

Time frame

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).

Time frame

6 months

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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®.

Time frame

12 months

Other outcomes

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).

Time frame

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).

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Beira Interior

Lead sponsor

Source ClinicalTrials.gov

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