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Completed

NCT Number: NCT04979702

mHealth Biometrics for Sedentary People (MotivateLJMU)

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.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Control

Behavioral

Participants will complete a 3-month exercise and physical activity intervention supported by online recourses

mHealth technology assisted exercise counselling

Behavioral

Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology

Primary outcomes

  1. Device derived adherence to structured exercise

    Time frame: Through study completion, an average 12 weeks

    Number of exercise sessions per week

  2. Device derived duration to structured exercise

    Time frame: Through study completion, an average 12 weeks

    minutes of exercise completed per session

  3. Device derived intensity of structured exercise

    Time frame: Through study completion, an average 12 weeks

    intensity of exercise sessions performed (% of HR max)

  4. 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

  5. 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

  1. Height

    Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)

    Height (m)

  2. Weight

    Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)

    Weight (kg)

  3. Waist Circumference

    Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)

    Waist Circumference (cm)

  4. Concentration of Hba1c

    Time frame: Baseline and immediately following intervention (12 weeks)

    Hba1c

  5. Blood Lipid concentrations

    Time frame: Baseline and immediately following intervention (12 weeks)

    Total cholesterol, HDL/LDL, Triglycerides

  6. Glycaemic control

    Time frame: Baseline and immediately following intervention (12 weeks)

    Flash glucose monitoring

  7. Patient qualitative survey on intervention acceptability

    Time frame: Immediately following intervention (12 weeks)

    Study specific questionnaire (qualitative data)

  8. Patient qualitative survey on testing acceptability

    Time frame: 7 Days following baseline testing

    Study specific questionnaire (qualitative data)

  9. Exercise motivation

    Time frame: 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

  10. 12-Item Short Form Survey

    Time frame: Baseline, Mid (week 6) and post (week 12)

    SF-12 Questionnaire (max 44 min 8, high score mean better outcome)

  11. Patient Interview to access intervention acceptability

    Time frame: Within 2 weeks of the end of the intervention

    Patient interview

  12. Patient Interview to access testing acceptability

    Time frame: Within 2 weeks of the baseline testing

    Patient interview

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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