Effects of a Lifestyle and Sleep Intervention Program on Quality of Life and Physical Activity Levels in Non-exercising Adults, SPIRAL+ Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Steps per day
研究概览
简要总结
Background. Cardiovascular diseases (CVDs) are the leading cause of premature mortality and disability accounting for one third of all deaths worldwide with considerable impacts on economics and on quality of life. Recent studies suggest that a lifestyle intervention might have a role in the reduction of CDV risk. Lifestyle intervention programs typically combine physical activity, diet and behavior modification components. Poor sleep health is highly prevalent in the general population and contributes to increased risk of several noncommunicable diseases. However, sleep is rarely addressed in lifestyle intervention programs in primary prevention. Given the high prevalence of poor sleep health in people without a diagnosed sleep disorder, and the associated health consequences, there is a clear need for broad-reaching, effective interventions to improve sleep quality in subclinical populations.
Aims. The main objective of this study is to compare a lifestyle intervention program including a sleep intervention compared to a lifestyle intervention program alone on the health-related quality of life (measured by the EQ-5D-5L) and physical activity levels of non-exercising adults.
Methods. Non-exercising adults (n=201) will be recruited in the community via advertisement or their primary care doctor and then randomized to one of the following 3 groups : lifestyle intervention, lifestyle and sleep intervention or standard care. The lifestyle intervention includes a physical activity component (physical activity initiation visit and 6 months of supervised physical activity, once weekly), a diet component (consultation with a dietician and 3 group sessions). The sleep intervention includes individualized face-to-face sessions aimed at improving and optimizing sleep hygiene.
At baseline and after 6 and 12 months, quality of life, physical activity levels, cardiovascular and metabolic risk factors will be evaluated.
Perspectives. This study should determine whether adding a sleep intervention dimension to a lifestyle intervention program provides significant benefits in terms of quality of life and physical activity levels. Based on this study, the modalities of real-life lifestyle intervention programs could be reconsidered in order to provide optimal primary prevention.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who is physically inactive (i.e. less than 150 minutes of moderate intensity physical activity per week)
- •Participant aged 18 to 80 years old
- •Participant able to provide written informed consent
- •Participant able to participate in regular physical activity (no medical contraindication to exercise)
- •Participant affiliated to social security or a similar regimen
排除标准
- •Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study
- •A participant who scores 11111 on the EQ-5D-5L questionnaire
- •A diagnosed and treated sleep disturbance (sleep apnea, insomnia, restless legs syndrome)
- •Persons concerned by articles L1121-5, L1121-6 and L1121-8 of the public health code (i.e. pregnancy, person deprived of liberty or subject to a legal protection measure, vulnerable person or legally protected adult)
- •Person already included in another interventional study
结局指标
主要结局
Steps per day
时间窗: 6 months after randomization
Measured using an activity monitor (Actigraph)
Health-related quality of life
时间窗: 6 months after randomization
EuroQol (Europe Quality of Life) EQ-5D-5L questionnaire.The EQ-5D-5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system). The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The worst health state is (55555) and the best health state is (11111).
次要结局
- Vigorous intensity physical activity time(Baseline, 6 months and 12 months)
- Self-efficacy(Baseline, 6 months and 12 months)
- Sedentary time(Baseline, 6 months and 12 months)
- 6 minute walk test distance(Baseline, 6 months and 12 months)
- Insomnia Severity(Baseline, 6 months and 12 months)
- Subjective sleepiness(Baseline, 6 months and 12 months)
- Sleep quality(Baseline, 6 months and 12 months)
- Subjective sleep quality(Baseline, 6 months and 12 months)
- Modrate to vigorous intensity physical activity time(Baseline, 6 months and 12 months)
- Cardiorespiratory fitness (VO2peak)(Baseline, 6 months and 12 months)
- 24-hr systolic and diastolic blood pressure(Baseline, 6 months and 12 months)
- Body composition(Baseline, 6 months and 12 months)
- Grip strength(Baseline, 6 months and 12 months)
- Attitude towards physical activity practice(Baseline, 6 months and 12 months)
- Subjective norms(Baseline, 6 months and 12 months)
- Depressive symptoms(Baseline, 6 months and 12 months)
- Mental well-being(Baseline, 6 months and 12 months)
- Sleep duration(Baseline, 6 months and 12 months)
- Light intensity physical activity time(Baseline, 6 months and 12 months)
- Health-related quality of life(Baseline, 6 months and 12 months)
- Quality of life SF-36(Baseline, 6 months and 12 months)
- Anxiety symptoms(Baseline, 6 months and 12 months)
- Motivation toward physical activity(Baseline, 6 months and 12 months)
- Eating behavior(Baseline, 6 months and 12 months)
- Social deprivation(Baseline, 6 months and 12 months)