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Feasibility, Acceptability and the Effects of Two Publicly Available Physical Activity Mobile Apps

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ClinicalTrials.gov Identifier: NCT03565627
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:

Within the new digital health care landscape, the rise of health applications (apps) creates novel prospects for behaviour change opportunities. The commercial market is saturated with apps that aim to increase physical activity (PA) with more than 49,000 PA apps available in the major app stores in 2016 [1]. Despite the wide distribution and popularity of PA apps, research on the efficacy of the apps is lacking.

This project focuses on exploring the potential for increasing PA levels using 2 selected apps that are available on the market with participants that do not engage or perform very little PA. This study is timely because PA apps on the market are extremely popular and there is a clear need to this the potential of these potentially convenient, accessible, wide-reaching, and cost-effective technology.

Before a large scale study is conducted, it is crucial to conduct assessment of the feasibility and acceptability of the study [2]. Feasibility determines if the study design, procedures, and the intervention can be executed by the researcher. Acceptability assesses the suitability of the study design, procedures, and the intervention from the perspective of the participants and intervention deliverers [3]. Hence, this mixed-methods feasibility study was designed to inform a decision about whether to proceed to a large-scale study. The aim of this study is to investigate the feasibility and acceptability of a study assessing 2 selected PA apps to inform the design of a definitive RCT, and to assess the effects of the app interventions on PA


Condition or disease Intervention/treatment Phase
PHYSICAL FITNESS Device: Exercise app: 7 Minute Workout Challenge Device: Running app: One You Couch to 5K Not Applicable

Detailed Description:

The aim of this research project is to investigate the feasibility and acceptability of a study assessing 2 selected PA apps to inform the design of a definitive randomised controlled trial, and to assess the effects of the app interventions on PA.

To address the aim, an explanatory mixed-methods study using quantitative (phase 1) and qualitative (phase 2) design will be used. Target population will be those that do not engage, or engage in low levels, of PA and the investigators will aim at recruiting participants from London and surrounding areas.

The primary objective is to determine the feasibility and acceptability of the trial procedures and the interventions delivered using apps.

The secondary objectives are to explore potential effects of the 2 selected PA apps on behavioural and psychological outcomes, and to assess the usability of the apps.

Phase 1 Phase 1 will utilise a crossover which means that half of the participants will be randomly assigned to use 1 of the 2 apps, while the other half will use the 2nd app. After 2 weeks participants will switch.

Participants will complete a baseline assessment (1 week), followed by the randomisation to using 1 of the 2 apps (2 weeks' follow up), and crossover (4 weeks' follow up). The primary outcome of the study will be average percent increase in activity count and will be measured using accelerometer. The secondary measures include exercise self-efficacy, intentions, apps usability and usage.

Phase 2 Following the end of phase 1, a semi-structured interview will be conducted to explore the acceptability and experiences of using the 2 apps (phase 2). The sample will include participants that took part in the crossover trial and consented to being interviewed. Participants that showed frequent usage of the apps, as well as those who used the app infrequently and/or discontinued using the app will be interviewed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will complete a baseline assessment (1 week), followed by the randomisation to using 1 of the 2 apps (3 weeks' follow up), and crossover (5 weeks' follow up).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Feasibility and Acceptability of a Randomised Crossover Trial Assessing Two Current Health Apps for Increasing Physical Activity: a Mixed Methods Study
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : July 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise app
7 Minute Workout Challenge by Fitness Guide Inc.
 Device: Exercise app: 7 Minute Workout Challenge
7 Minute Workout Challenge by Fitness Guide Inc. combines aerobic and resistance training into short, 7 minute high intensity circuit training.
Experimental: Running App
One You Couch to 5K by Public Health England
 Device: Running app: One You Couch to 5K
One You Couch to 5K by Public Health England is a popular app that aims to increase fitness by asking the user to follow a running programme with a goal to run for 30 min without break.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment rates as a percentage of eligible participants that consented to partake in the study [ Time Frame: Week 5 ]
    Determined by retention (%)


Secondary Outcome Measures :
  1. Retention measured by completeness of data at 5 weeks' follow up [ Time Frame: Week 5 ]
    Determined by retention (%)

  2. Acceptability of the trial procedures and the interventions [ Time Frame: Week 5 ]
    Semi-structured interviews following the completion of the trial

  3. Change in objectively measured PA from baseline to follow-up [ Time Frame: Week 3 and 5 ]
    Measured by hip-worn ActiGraph GT3X+

  4. The difference in PA change between the 2 apps [ Time Frame: Week 3 and 5 ]
    Measured by hip-worn ActiGraph GT3X+

  5. Change in self-reported PA [ Time Frame: Week 3 and 5 ]
    Using International Physical Activity Questionnaires: short last 7 days self-administered format

  6. Change in exercise self-efficacy [ Time Frame: Week 3 and 5 ]
    Measured using Self-Efficacy to Regulate Exercise

  7. Change in PA outcome expectancy measure [ Time Frame: Week 3 and 5 ]
    Assessed using Physical Activity Outcome Expectancy Measure

  8. Usability of the apps [ Time Frame: Week 3 and 5 ]
    Assessed using System Usability Scale

  9. Change in mood [ Time Frame: Week 5 ]
    Assessed daily using PACO app

  10. Usage of apps [ Time Frame: Week 13 ]
    Long-term usage of apps will be assessed by asking participants if they have any of the apps on the phones and if they have used it since the end of the study


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults (≥18 years' old) identified as "moderately inactive" or "inactive" using General Practice Physical Activity Questionnaire
  • as the use of accelerometer requires some maintenance from the researcher, it was necessary to include only users that reside in/around London for practical reasons
  • willingness to try the apps assessed in the study (walking and workout app)
  • those owning a smartphone, iPhone (operating iOS 6.0 or newer and ) or Android (version 2.3.3 and up

Exclusion Criteria:

  • do not speak English
  • previous use of the apps of interest
  • medical conditions that require special attention when conducting physical activity
  • current participation in another research study that targets behaviour change
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565627


Locations
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United Kingdom
eHealth Unit, Research Department of Primary Care and Population Health, University College London
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
University College, London
Medical Research Council
Investigators
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Principal Investigator: Fiona Hamilton, MD, PhD University College, London
Study Chair: Elizabeth Murray, MD, PhD University College, London
More Information
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Publications:
research2guidance. mHealth app developer economics. The state of the art of mHealth application publishing: research2guidance 2014 [updated 5 May 2016]. Available from: http://research2guidance.com/product/mhealth-app-developer-economics-2014/.

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03565627    
Other Study ID Numbers: 11121/001
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
mHealth
digital health
behavior change
physical activity
mobile apps