mHealth Biometrics for Sedentary People (MotivateLJMU)

NCT ID: NCT04979702

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

No masking

Study Groups

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Active Control

Patients will have access to our online exercise resources throughout the 12-week intervention.

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

mHealth technology assisted exercise counselling

Intervention Type BEHAVIORAL

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

Interventions

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Active Control

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Matthew Cocks

Lecturer in Muscle Biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Liverpool John Moores University

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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MotivateLJMU

Identifier Type: -

Identifier Source: org_study_id

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