Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALActive Control
Participants will complete a 3-month exercise and physical activity intervention supported by online recourses
Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology
Sponsors
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device derived adherence to structured exercise | Through study completion, an average 12 weeks | Number of exercise sessions per week |
| Device derived duration to structured exercise | Through study completion, an average 12 weeks | minutes of exercise completed per session |
| Device derived intensity of structured exercise | Through study completion, an average 12 weeks | intensity of exercise sessions performed (% of HR max) |
| Change in Device derived physical activity (GENEActiv) | 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)) | Baseline, 4, 6, 8 12 weeks | Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic control | Baseline and immediately following intervention (12 weeks) | Flash glucose monitoring |
| Patient qualitative survey on intervention acceptability | Immediately following intervention (12 weeks) | Study specific questionnaire (qualitative data) |
| Patient qualitative survey on testing acceptability | 7 Days following baseline testing | Study specific questionnaire (qualitative data) |
| Height | Baseline, 6-weeks and immediately following intervention (12 weeks) | Height (m) |
| 12-Item Short Form Survey | Baseline, Mid (week 6) and post (week 12) | SF-12 Questionnaire (max 44 min 8, high score mean better outcome) |
| Patient Interview to access intervention acceptability | Within 2 weeks of the end of the intervention | Patient interview |
| Patient Interview to access testing acceptability | Within 2 weeks of the baseline testing | Patient interview |
| Exercise motivation | Baseline, Mid (week 6) and post (week 12) | Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better |
| Weight | Baseline, 6-weeks and immediately following intervention (12 weeks) | Weight (kg) |
| Waist Circumference | Baseline, 6-weeks and immediately following intervention (12 weeks) | Waist Circumference (cm) |
| Concentration of Hba1c | Baseline and immediately following intervention (12 weeks) | Hba1c |
| Blood Lipid concentrations | Baseline and immediately following intervention (12 weeks) | Total cholesterol, HDL/LDL, Triglycerides |
Countries
United Kingdom
Outcome results
None listed