mHealth Biometrics for Sedentary People (MotivateLJMU)

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Active Control; Behavioral: mHealth technology assisted exercise counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L33AF
    • Liverpool John Moores University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control; Patients will have access to our online exercise resources throughout the 12-week intervention.	Behavioral: Active Control; Participants will complete a 3-month exercise and physical activity intervention supported by online recourses
Experimental: Experimental: mHealth technology assisted exercise counselling (mHealth); 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; Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology

What is the study measuring?

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
Patient Interview to access intervention acceptability	Patient interview	Within 2 weeks of the end of the intervention
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 testing acceptability	Patient interview	Within 2 weeks of the baseline testing

Collaborators and Investigators

• Sponsor: Liverpool John Moores University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MotivateLJMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No