mHealth Biometrics for Sedentary People (MotivateLJMU)
- Conditions
- Healthy
- Interventions
- Behavioral: Active ControlBehavioral: mHealth technology assisted exercise counselling
- Registration Number
- NCT04979702
- Lead Sponsor
- Liverpool John Moores University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Control Active Control Patients will have access to our online exercise resources throughout the 12-week intervention. Experimental: mHealth technology assisted exercise counselling (mHealth) mHealth technology assisted exercise counselling 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.
- Primary Outcome Measures
Name Time Method Device derived adherence to structured exercise Through study completion, an average 12 weeks Number of exercise sessions per week
Device derived intensity of structured exercise Through study completion, an average 12 weeks intensity of exercise sessions performed (% of HR max)
Device derived duration to structured exercise Through study completion, an average 12 weeks minutes of exercise completed per session
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 Outcome Measures
Name Time Method Patient qualitative survey on testing acceptability 7 Days following baseline testing Study specific questionnaire (qualitative data)
Glycaemic control Baseline and immediately following intervention (12 weeks) Flash glucose monitoring
Waist Circumference Baseline, 6-weeks and immediately following intervention (12 weeks) Waist Circumference (cm)
Patient qualitative survey on intervention acceptability Immediately following intervention (12 weeks) Study specific questionnaire (qualitative data)
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
Height Baseline, 6-weeks and immediately following intervention (12 weeks) Height (m)
Weight Baseline, 6-weeks and immediately following intervention (12 weeks) Weight (kg)
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
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
Patient Interview to access testing acceptability Within 2 weeks of the baseline testing Patient interview
Trial Locations
- Locations (1)
Liverpool John Moores University
🇬🇧Liverpool, United Kingdom