Treatment of Overweight and Obesity in Adolescents - Impact of a Sleep Behavioral Intervention - SLEEP-OB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- BMI z-score at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization is performed by a researcher not involved in data management.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
Standard interventions focused on nutrition, physical activity/sedentary behavior, and other lifestyle aspects.
干预措施: Standard Obesity Treatment (Other)
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.
干预措施: Sleep Behavioral Intervention (Behavioral)
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.
干预措施: Standard Obesity Treatment (Other)
结局指标
主要结局
BMI z-score at 6 months
时间窗: 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.
BMI at 6 months
时间窗: 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.
Fat mass percentage at 6 months
时间窗: 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®.
Fat-free mass index at 6 months
时间窗: 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).
次要结局
- Change in sleep quality - actigrafy(6 months)
- Fat mass percentage at 12 months(12 months)
- 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-free mass index at 12 months(12 months)
- BMI z-score at 12 months(12 months)
- BMI at 12 months(12 months)
- Change in Waist-to-height Ratio(6 months and 12 months)
- Change in C-reactive protein(6 months and 12 months)
- Change in Fasting Lipid: Total Cholesterol(6 months and 12 months)
- Change in Fasting Lipid: LDL-cholesterol(6 months and 12 months)
- Change in Fasting Lipid: HDL-cholesterol(6 months and 12 months)
- Change in Fasting Lipid: Triglycerides(6 months and 12 months)
- Change in centiles of Systolic and Diastolic Blood Pressure(6 months and 12 months)
- Change in HbA1c(6 months and 12 months)
- Change in Glycaemic Category(6 months and 12 months)
- Change in HOMA-B(6 months and 12 months)
- Change in HOMA-IR(6 months and 12 months)
- Change in Continuous metabolic syndrome score(6 months and 12 months)
- Change in Sleep quality(6 months and 12 months)
- Change in Respiratory Sleep disorder(6 months)
- Change in Diet Quality(6 months)
- Change in Eating behavior(6 months)
- Change in emotional well-being(6 months)
- Change in Quality of life(6 months)
- Change in self-compassion(6 months)
- Change in Physical activity(6 months)
- Change in Physical activity - actigraphy(6 months)
研究者
ana sofia rodrigues ferreira
PhD student
University of Beira Interior