A Pilot Study to Assess the Feasibility and Adherence of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Body weight (kg)
研究概览
简要总结
The primary objective of the proposed study is to develop, deliver and assess the feasibility and adherence to a targeted behavioral sleep intervention for sleep impaired obese patients.
Secondary objectives are to demonstrate that a targeted behavioral sleep intervention can improve treatment outcomes in obese adult outpatients enrolled to a lifestyle and dietary modification program; and to demonstrate that a targeted behavioral sleep intervention enhances the long-term maintenance of treatment gains in obese adults enrolled in a lifestyle and dietary modification program.
Those with sleep impairment (sleep duration of ≤6.5hours per 24-hours; and/or poor sleep quality [<85% efficiency]; and/or misaligned nocturnal sleep timing [>03:00 on weekdays]) who are also obese (Body Mass Index [BMI] ≥27.5 kg/m2) will be recruited and randomized to a 12-week weight loss intervention with/without sleep improvement. Volunteers will be followed for a further six months to assess multiple outcome measures.
It is hypothesised that inclusion of a targeted behavioral sleep improvement intervention will be feasible and acceptable and will enhance immediate and long-term treatment outcomes of obese adults enrolled to a lifestyle and dietary modification program. The results of the study will be used to better inform the design and development of a future Randomized Controlled Trial (RCT).
Sleep improvement may be incorporated into weight management treatments as a cost-effective alternative/addition.
详细描述
The primary objective of the proposed study is to develop, deliver and assess the feasibility and adherence to a targeted behavioral sleep intervention for sleep impaired obese patients.
Secondary objectives are to demonstrate that a targeted behavioral sleep intervention can improve treatment outcomes in obese adult outpatients enrolled to a lifestyle and dietary modification program; and to demonstrate that a targeted behavioral sleep intervention enhances the long-term maintenance of treatment gains in obese adults enrolled in a lifestyle and dietary modification program.
Those with sleep impairment (sleep duration of ≤6.5hours per 24-hours; and/or poor sleep quality [<85% efficiency]; and/or misaligned nocturnal sleep timing [>03:00 on weekdays]) who are also obese (Body Mass Index [BMI] ≥27.5 kg/m2) will be recruited and randomized to a 12-week weight loss intervention (based on a previously developed specialist lifestyle management program) with/without sleep improvement (based on a cognitive behaviour treatment developed to treatment sleep problems in US military). Volunteers will be followed for a further six months to assess multiple outcome measures. Other secondary measures to be assessed are mood (Hospital Anxiety Depression Scale [HADS], food intake (24-hour food recall), quality of life (IWQOL-LITE & EQ-5D), and sleep (PSQI & RU_SATED), all of which will be assessed using validated questionnaires that have been previously assessed for reliability.
It is hypothesised that inclusion of a targeted behavioral sleep improvement intervention will be feasible and acceptable and will enhance immediate and long-term treatment outcomes of obese adults enrolled to a lifestyle and dietary modification program. The results of the study will be used to better inform the design and development of a future Randomized Controlled Trial (RCT).
Sleep improvement may be incorporated into weight management treatments as a cost-effective alternative/addition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sleep impaired individuals defined as meeting one or more of the following objectively estimated sleep feature: 1) ≤6.5hours per 24-hours; 2) poor sleep quality (<85% efficiency); 3) misaligned nocturnal sleep timing (>03:00 on weekdays);
- •Obese (BMI ≥27.5 kg/m2 for Asians/Arabs or BMI ≥30.0 kg/m2 for Europeans/Caucasians);
- •Men/women;
- •Age 18-50 years (upper age limit chosen due to specific alterations in sleep duration and quality commonly observed after this age);
- •Good English language comprehension/communication skills;
- •Able to provide informed consent and willing to participate in the study.
排除标准
- •Currently taking medication(s) that may interfere with weight loss (e.g. corticosteroids);
- •Contraindications to use of the Cambridge Weight Plan (heart attack or stroke three months preceding study participation; lactose intolerance; gallstones; porphyria; active gout);
- •Medications that may interfere with sleep;
- •Clinically diagnosed sleep disorder(s) or those at high risk of undiagnosed OSA based on three questionnaires (Berlin, ESS, STOP-BANG);
- •Chronic illness (asthma, COPD, diabetes, arthritis, fibromyalgia, heart condition, kidney or liver disease);
- •Uncontrolled hypertension;
- •Polycystic ovary syndrome;
- •Endocrine disorder(s), except for stable treated hypothyroidism;
- •Psychiatric disorder(s), except for stable treated depression;
- •Currently taking monoamine oxidase inhibitor medication;
- •Previous/planned bariatric surgery;
- •Diagnosed eating disorders;
- •Night-shift workers;
- •Substance use;
- •Excessive alcohol consumption;
- •Known pregnancy or planned pregnancy during the study/breastfeeding or given birth in last 3 months;
- •Family circumstances e.g. infants, young children, pets that will make study adherence difficult.
结局指标
主要结局
Body weight (kg)
时间窗: 3 months
Amount of group weight loss by group will be calculated and compared at the end of the 12-week intervention period
次要结局
- Hospital Anxiety & Depression Scale (HADS)(6 months)
- Impact of Weight on Quality of Life (IWQOL-LITE)(6 months)
- Body weight (kg) loss maintenance(6 months)