NCT04979702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

July 16, 2021

Last Update Submit

August 22, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (12)

  • Height

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

  • Weight

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

  • Waist Circumference

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

  • Concentration of Hba1c

    Baseline and immediately following intervention (12 weeks)

  • Blood Lipid concentrations

    Baseline and immediately following intervention (12 weeks)

  • +7 more secondary outcomes

Study Arms (2)

Active Control

ACTIVE COMPARATOR

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

Behavioral: Active Control

Experimental: mHealth technology assisted exercise counselling (mHealth)

EXPERIMENTAL

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

Interventions

Active ControlBEHAVIORAL

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

Active Control
mHealth technology assisted exercise counsellingBEHAVIORAL

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

Experimental: mHealth technology assisted exercise counselling (mHealth)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Muscle Biochemistry

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 28, 2021

Study Start

August 1, 2020

Primary Completion

April 1, 2022

Study Completion

July 1, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations

GB(1)