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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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PHYSICAL FITNESS

Intervention / Treatment
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* Device: Exercise app: 7 Minute Workout Challenge
* Device: Running app: One You Couch to 5K


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise app<br>7 Minute Workout Challenge by Fitness Guide Inc. | Device: Exercise app: 7 Minute Workout Challenge<br>* 7 Minute Workout Challenge by Fitness Guide Inc. combines aerobic and resistance training into short, 7 minute high intensity circuit training.<br>|
| Experimental: Running App<br>One You Couch to 5K by Public Health England | Device: Running app: One You Couch to 5K<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rates as a percentage of eligible participants that consented to partake in the study | Determined by retention (%) | Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention measured by completeness of data at 5 weeks' follow up | Determined by retention (%) | Week 5 | 
| Acceptability of the trial procedures and the interventions | Semi-structured interviews following the completion of the trial | Week 5 | 
| Change in objectively measured PA from baseline to follow-up | Measured by hip-worn ActiGraph GT3X+ | Week 3 and 5 | 
| The difference in PA change between the 2 apps | Measured by hip-worn ActiGraph GT3X+ | Week 3 and 5 | 
| Change in self-reported PA | Using International Physical Activity Questionnaires: short last 7 days self-administered format | Week 3 and 5 | 
| Change in exercise self-efficacy | Measured using Self-Efficacy to Regulate Exercise | Week 3 and 5 | 
| Change in PA outcome expectancy measure | Assessed using Physical Activity Outcome Expectancy Measure | Week 3 and 5 | 
| Usability of the apps | Assessed using System Usability Scale | Week 3 and 5 | 
| Change in mood | Assessed daily using PACO app | Week 5 | 
| Usage of apps | 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 | Week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, digital health, behavior change, physical activity, mobile apps