E-health Interventions to Promote Physical Activity Among Inactive Adults: a Hybrid Type I Effectiveness-implementation Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Level of physical activity long-term
研究概览
简要总结
The project addresses physical inactivity as a global health issue. Physical inactivity is the fourth leading risk factor for global mortality. Moreover, inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy in the use of certain strategies including fitness technologies and digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness of PA promotion strategies.
A Hybrid Type I effectiveness-implementation randomised controlled trial (RCT) will investigate the effects of 1) fitness trackers, 2) home-based online training, and 3) peer support via social media among inactive adults. The design will allow testing the study outcomes while gathering information on implementation in a real-world situation. The study will produce evidence on whether these interventions increase the levels of PA among inactive adults and improve health outcomes. Increased PA will also result in better primary prevention of lifestyle diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •young (18-40 years) or middle aged (40-55 years) healthy adults, both men and women;
- •inactive (undertaking less than 150 min of moderate-intensity PA per week) in the last 3 months;
- •living in the Troms and Finnmark county;
- •current owner of a smartphone;
- •able to understand training instructions in English language.
排除标准
- •presence of disabilities which might reduce the ability to perform exercise;
- •presence of conditions which might prevent from safely exercise;
- •lack of Internet connection at home;
- •lack of space to exercise safely at home (recommended 4 sqm).
结局指标
主要结局
Level of physical activity long-term
时间窗: 18 months
Time spent in moderate to vigorous physical activity
Level of physical activity medium-term
时间窗: 12 months
Time spent in moderate to vigorous physical activity
Level of physical activity short-term
时间窗: 6 months
Time spent in moderate to vigorous physical activity
次要结局
- Adherence to recommendation short-term(6 months)
- Adherence to recommendation long-term(18 months)
- Waist circumference short-term(6 months)
- Perceived competence for exercise (PCS-EX) medium-term(12 months)
- Perceived competence for exercise (PCS-EX) long-term(18 months)
- Social Support and Exercise scale (SSES) long-term(18 months)
- Reasons for performing physical activity short-term(6 months)
- Reasons for performing physical activity medium-term(12 months)
- Users' perspectives on intervention through interviews short-term(6 months)
- Users' perspectives on intervention through interviews long-term(18 months)
- Adherence to recommendation medium-term(12 months)
- Body Mass Index (BMI) medium-term(12 months)
- Waist circumference medium-term(12 months)
- Waist circumference long-term(18 months)
- EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life medium-term(12 months)
- Perceived competence for exercise (PCS-EX) short-term(6 months)
- Reasons for performing physical activity long-term(18 months)
- Physical fitness medium-term(12 months)
- Physical fitness long-term(18 months)
- Body Mass Index (BMI) short-term(6 months)
- EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life short-term(6 months)
- EQ-5D-5L (EuroQol 5 Dimension 5 Level) Quality of life long-term(18 months)
- Self-efficacy for exercise (SEE) Scale long-term(18 months)
- Physical fitness short-term(6 months)
- Body Mass Index (BMI) long-term(18 months)
- Self-efficacy for exercise (SEE) Scale short-term(6 months)
- Self-efficacy for exercise (SEE) Scale medium-term(12 months)
- Social Support (SSES) medium-term(12 months)
- System Usability Scale (SUS)(6 months)
- Social Support (SSES) short-term(6 months)
研究者
Paolo Zanaboni
Senior researcher
University Hospital of North Norway