Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Device derived adherence to structured exercise
研究概览
简要总结
The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in previously sedentary individuals. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
详细描述
Participants will be recruited from Liverpool John Moores University, and other local office-based businesses. Participants will be randomised to either online exercise resources only (n=50) or exercise counselling + mHealth (n=50).This is a pilot parallel group, randomised controlled trial whereby consenting participants will complete baseline testing (T1) before starting a 12-week exercise intervention supported by online resources only (online resources intervention) or online resources and a programme of exercise counselling enhanced with mobile health (mHealth) technology (mHealth intervention). Participants will repeat baseline assessments (i) 6-weeks into the intervention (T2) and, (ii) immediately post-intervention (T3). Testing at baseline and following the 12-week intervention will include changes in physical activity, blood pressure, body composition and glycaemia control (n=20).
Both groups will have access to online resources throughout the 12-week programme. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 4 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates.
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
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Aged 18-75
- •No known cardiovascular or metabolic disorder (e.g. heart failure, diabetes, previous myocardial infarction etc.)
- •Able to exercise safely as deemed by completion of the PAR-Q+.
- •Not currently meeting the recommended exercise guidelines (150 minutes moderate or 75 minutes of vigorous intensity physical activity per week), as assessed during screening questions related to the participants previous activity levels.
排除标准
- •Aged <18 or >75
- •Pregnancy or planning to become pregnant in the next 3 months
- •<6 months postpartum or stopped breastfeeding <1 month before recruitment
- •Not owning a smartphone with a data plan or access to WiFi
结局指标
主要结局
Device derived adherence to structured exercise
时间窗: Through study completion, an average 12 weeks
Number of exercise sessions per week
Device derived intensity of structured exercise
时间窗: Through study completion, an average 12 weeks
intensity of exercise sessions performed (% of HR max)
Device derived duration to structured exercise
时间窗: Through study completion, an average 12 weeks
minutes of exercise completed per session
Change in Device derived physical activity (GENEActiv)
时间窗: Baseline, Mid intervention (Week 6-7), the final 2 weeks of intervention period (weeks 10-12).
minutes of Moderate and Vigorous physical activity
Change in Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
时间窗: Baseline, 4, 6, 8 12 weeks
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
次要结局
- Glycaemic control(Baseline and immediately following intervention (12 weeks))
- Patient qualitative survey on testing acceptability(7 Days following baseline testing)
- Patient qualitative survey on intervention acceptability(Immediately following intervention (12 weeks))
- Waist Circumference(Baseline, 6-weeks and immediately following intervention (12 weeks))
- Exercise motivation(Baseline, Mid (week 6) and post (week 12))
- Height(Baseline, 6-weeks and immediately following intervention (12 weeks))
- Weight(Baseline, 6-weeks and immediately following intervention (12 weeks))
- 12-Item Short Form Survey(Baseline, Mid (week 6) and post (week 12))
- Patient Interview to access intervention acceptability(Within 2 weeks of the end of the intervention)
- Concentration of Hba1c(Baseline and immediately following intervention (12 weeks))
- Blood Lipid concentrations(Baseline and immediately following intervention (12 weeks))
- Patient Interview to access testing acceptability(Within 2 weeks of the baseline testing)
研究者
Matthew Cocks
Lecturer in Muscle Biochemistry
Liverpool John Moores University