Clinical trial NCT04979702: mHealth Biometrics for Sedentary People (MotivateLJMU)
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device derived adherence to structured exercise
timeFrame: Through study completion, an average 12 weeks
measure: Device derived duration to structured exercise
timeFrame: Through study completion, an average 12 weeks
measure: Device derived intensity of structured exercise
timeFrame: Through study completion, an average 12 weeks
measure: Change in Device derived physical activity (GENEActiv)
timeFrame: Baseline, Mid intervention (Week 6-7), the final 2 weeks of intervention period (weeks 10-12).
measure: Change in Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
timeFrame: Baseline, 4, 6, 8 12 weeks
Secondary outcomes:
measure: Height
timeFrame: Baseline, 6-weeks and immediately following intervention (12 weeks)
measure: Weight
timeFrame: Baseline, 6-weeks and immediately following intervention (12 weeks)
measure: Waist Circumference
timeFrame: Baseline, 6-weeks and immediately following intervention (12 weeks)
measure: Concentration of Hba1c
timeFrame: Baseline and immediately following intervention (12 weeks)
measure: Blood Lipid concentrations
timeFrame: Baseline and immediately following intervention (12 weeks)
measure: Glycaemic control
timeFrame: Baseline and immediately following intervention (12 weeks)
measure: Patient qualitative survey on intervention acceptability
timeFrame: Immediately following intervention (12 weeks)
measure: Patient qualitative survey on testing acceptability
timeFrame: 7 Days following baseline testing
measure: Exercise motivation
timeFrame: Baseline, Mid (week 6) and post (week 12)
measure: 12-Item Short Form Survey
timeFrame: Baseline, Mid (week 6) and post (week 12)
measure: Patient Interview to access intervention acceptability
timeFrame: Within 2 weeks of the end of the intervention
measure: Patient Interview to access testing acceptability
timeFrame: Within 2 weeks of the baseline testing
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
Study officials:
References: