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Completed

NCT Number: NCT03565627

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

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

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Key information

Conditions

Physical Fitness Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

eHealth Unit, Research Department of Primary Care and Population Health, University College London

London, NW3 2QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise app: 7 Minute Workout Challenge

Device

7 Minute Workout Challenge by Fitness Guide Inc. combines aerobic and resistance training into short, 7 minute high intensity circuit training.

Running app: One You Couch to 5K

Device

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.

Primary outcomes

  1. Recruitment rates as a percentage of eligible participants that consented to partake in the study

    Time frame: Week 5

    Determined by retention (%)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

The Feasibility and Acceptability of a Randomised Crossover Trial Assessing Two Current Health Apps for Increasing Physical Activity: a Mixed Methods Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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