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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
86
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
Liverpool John Moores University
Liverpool, United Kingdom
Device derived adherence to structured exercise
Number of exercise sessions per week
Time frame: Through study completion, an average 12 weeks
Device derived duration to structured exercise
minutes of exercise completed per session
Time frame: Through study completion, an average 12 weeks
Device derived intensity of structured exercise
intensity of exercise sessions performed (% of HR max)
Time frame: Through study completion, an average 12 weeks
Change in Device derived physical activity (GENEActiv)
minutes of Moderate and Vigorous physical activity
Time frame: Baseline, Mid intervention (Week 6-7), the final 2 weeks of intervention period (weeks 10-12).
Change in Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Time frame: Baseline, 4, 6, 8 12 weeks
Height
Height (m)
Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)
Weight
Weight (kg)
Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)
Waist Circumference
Waist Circumference (cm)
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Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)
Concentration of Hba1c
Hba1c
Time frame: Baseline and immediately following intervention (12 weeks)
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Time frame: Baseline and immediately following intervention (12 weeks)
Glycaemic control
Flash glucose monitoring
Time frame: Baseline and immediately following intervention (12 weeks)
Patient qualitative survey on intervention acceptability
Study specific questionnaire (qualitative data)
Time frame: Immediately following intervention (12 weeks)
Patient qualitative survey on testing acceptability
Study specific questionnaire (qualitative data)
Time frame: 7 Days following baseline testing
Exercise motivation
Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better
Time frame: Baseline, Mid (week 6) and post (week 12)
12-Item Short Form Survey
SF-12 Questionnaire (max 44 min 8, high score mean better outcome)
Time frame: Baseline, Mid (week 6) and post (week 12)
Patient Interview to access intervention acceptability
Patient interview
Time frame: Within 2 weeks of the end of the intervention
Patient Interview to access testing acceptability
Patient interview
Time frame: Within 2 weeks of the baseline testing