mHealth Biometrics for Sedentary People (MotivateLJMU)

Healthy Clinical Trial

Official title:

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979702
• Other study ID #: MotivateLJMU
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Active Control
Participants will complete a 3-month exercise and physical activity intervention supported by online recourses
• 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

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device derived adherence to structured exercise	Number of exercise sessions per week	Through study completion, an average 12 weeks
Primary	Device derived duration to structured exercise	minutes of exercise completed per session	Through study completion, an average 12 weeks
Primary	Device derived intensity of structured exercise	intensity of exercise sessions performed (% of HR max)	Through study completion, an average 12 weeks
Primary	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).
Primary	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	Height	Height (m)	Baseline, 6-weeks and immediately following intervention (12 weeks)
Secondary	Weight	Weight (kg)	Baseline, 6-weeks and immediately following intervention (12 weeks)
Secondary	Waist Circumference	Waist Circumference (cm)	Baseline, 6-weeks and immediately following intervention (12 weeks)
Secondary	Concentration of Hba1c	Hba1c	Baseline and immediately following intervention (12 weeks)
Secondary	Blood Lipid concentrations	Total cholesterol, HDL/LDL, Triglycerides	Baseline and immediately following intervention (12 weeks)
Secondary	Glycaemic control	Flash glucose monitoring	Baseline and immediately following intervention (12 weeks)
Secondary	Patient qualitative survey on intervention acceptability	Study specific questionnaire (qualitative data)	Immediately following intervention (12 weeks)
Secondary	Patient qualitative survey on testing acceptability	Study specific questionnaire (qualitative data)	7 Days following baseline testing
Secondary	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)
Secondary	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)
Secondary	Patient Interview to access intervention acceptability	Patient interview	Within 2 weeks of the end of the intervention
Secondary	Patient Interview to access testing acceptability	Patient interview	Within 2 weeks of the baseline testing