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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
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 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.
Unidade Local de Saúde Cova da Beira
Covilha, Portugal
RECRUITINGHospital CUF Porto
Porto, Portugal
NOT_YET_RECRUITINGBMI 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
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Change in Waist-to-height Ratio
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Time frame: 6 months and 12 months
Change in C-reactive protein
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months and 12 months
Change in Fasting Lipid: Triglycerides
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Time frame: 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.
Time frame: 6 months and 12 months
Change in HbA1c
Variation between Visit 1 and Visit 4, and between Visit 1 and Visit 6.
Time frame: 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%
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 months and 12 months
Change in sleep quality - actigrafy
Sleep quality assessed by actigraphy and sleep diary, at Visit 1and Visit 4.
Time frame: 6 months
Change in Respiratory Sleep disorder
Respiratory sleep disorder assessed by the Pediatric sleep questionnaire at Visit 1and Visit 4.
Time frame: 6 months
Change in Diet Quality
Mediterranean Diet Quality assessed with KIDMED questionnaire, at Visit 1 and Visit 4.
Time frame: 6 months
Change in Eating behavior
MEating behavior assessed with Eating Attitudes Test questionnaire, at Visit 1 and Visit 4.
Time frame: 6 months
Change in emotional well-being
At Visit 1 and Visit 4: Emotional well-being assessed through the WHO-5.
Time frame: 6 months
Change in Quality of life
At Visit 1 and Visit 4: Quality of life evaluated with the KIDSCREEN 52 questionnaire.
Time frame: 6 months
Change in self-compassion
At Visit 1 and Visit 4: Self-compassion evaluated with the Self-Compassion Scale for adolescents.
Time frame: 6 months
Change in Physical activity
Physical activity assessed with International Physical Activity Questionnaire for Adolescents, at Visit 1 and Visit 4.
Time frame: 6 months
Change in Physical activity - actigraphy
Physical activity assessed by actigraphy, at Visit 1 and Visit 4.
Time frame: 6 months
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