mHealth Biometrics for Sedentary People (MotivateLJMU)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Active Control
* Behavioral: mHealth technology assisted exercise counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Control<br>Patients will have access to our online exercise resources throughout the 12-week intervention. | Behavioral: Active Control<br>* Participants will complete a 3-month exercise and physical activity intervention supported by online recourses<br>|
| Experimental: Experimental: mHealth technology assisted exercise counselling (mHealth)<br>Participants will complete a 12 week mHealth technology assisted exercise counselling intervention. Participants will co-develop a 3-month structured exercise and PA programme, with support from an exercise specialist. All participants will have 4 exercise consultations with their exercise specialist. The intervention will be supported by 3 mHealth elements; 1) a wrist worn fitness watch, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist. The 3 elements will be synced, allowing data to be transferred between platforms. | Behavioral: mHealth technology assisted exercise counselling<br>* Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device derived adherence to structured exercise | Number of exercise sessions per week | Through study completion, an average 12 weeks | 
| Device derived duration to structured exercise | minutes of exercise completed per session | Through study completion, an average 12 weeks | 
| Device derived intensity of structured exercise | intensity of exercise sessions performed (% of HR max) | Through study completion, an average 12 weeks | 
| Change in Device derived physical activity (GENEActiv) | minutes of Moderate and Vigorous physical activity | 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 | Baseline, 4, 6, 8 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height | Height (m) | Baseline, 6-weeks and immediately following intervention (12 weeks) | 
| Weight | Weight (kg) | Baseline, 6-weeks and immediately following intervention (12 weeks) | 
| Waist Circumference | Waist Circumference (cm) | Baseline, 6-weeks and immediately following intervention (12 weeks) | 
| Concentration of Hba1c | Hba1c | Baseline and immediately following intervention (12 weeks) | 
| Blood Lipid concentrations | Total cholesterol, HDL/LDL, Triglycerides | Baseline and immediately following intervention (12 weeks) | 
| Glycaemic control | Flash glucose monitoring | Baseline and immediately following intervention (12 weeks) | 
| Patient qualitative survey on intervention acceptability | Study specific questionnaire (qualitative data) | Immediately following intervention (12 weeks) | 
| Patient qualitative survey on testing acceptability | Study specific questionnaire (qualitative data) | 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 | 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) | Baseline, Mid (week 6) and post (week 12) | 
| Patient Interview to access intervention acceptability | Patient interview | Within 2 weeks of the end of the intervention | 
| Patient Interview to access testing acceptability | Patient interview | Within 2 weeks of the baseline testing |