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Clinical Trials/NCT04979702
NCT04979702
Completed
Not Applicable

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence

Liverpool John Moores University1 site in 1 country86 target enrollmentAugust 1, 2020
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Liverpool John Moores University
Enrollment
86
Locations
1
Primary Endpoint
Device derived adherence to structured exercise
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthew Cocks

Lecturer in Muscle Biochemistry

Liverpool John Moores University

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

Outcomes

Primary Outcomes

Device derived adherence to structured exercise

Time Frame: Through study completion, an average 12 weeks

Number of exercise sessions per week

Device derived intensity of structured exercise

Time Frame: Through study completion, an average 12 weeks

intensity of exercise sessions performed (% of HR max)

Device derived duration to structured exercise

Time Frame: Through study completion, an average 12 weeks

minutes of exercise completed per session

Change in Device derived physical activity (GENEActiv)

Time Frame: 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))

Time Frame: Baseline, 4, 6, 8 12 weeks

Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes

Secondary Outcomes

  • Glycaemic control(Baseline and immediately following intervention (12 weeks))
  • Patient qualitative survey on testing acceptability(7 Days following baseline testing)
  • Patient qualitative survey on intervention acceptability(Immediately following intervention (12 weeks))
  • Waist Circumference(Baseline, 6-weeks and immediately following intervention (12 weeks))
  • Exercise motivation(Baseline, Mid (week 6) and post (week 12))
  • Height(Baseline, 6-weeks and immediately following intervention (12 weeks))
  • Weight(Baseline, 6-weeks and immediately following intervention (12 weeks))
  • 12-Item Short Form Survey(Baseline, Mid (week 6) and post (week 12))
  • Patient Interview to access intervention acceptability(Within 2 weeks of the end of the intervention)
  • Concentration of Hba1c(Baseline and immediately following intervention (12 weeks))
  • Blood Lipid concentrations(Baseline and immediately following intervention (12 weeks))
  • Patient Interview to access testing acceptability(Within 2 weeks of the baseline testing)

Study Sites (1)

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