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

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

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

Study Overview

• Status: Completed
• Conditions: PHYSICAL FITNESS
• Intervention / Treatment: Device: Exercise app: 7 Minute Workout Challenge; Device: Running app: One You Couch to 5K

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW3 2QG
    • eHealth Unit, Research Department of Primary Care and Population Health, University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Medical Research Council
• Investigators: Principal Investigator: Fiona Hamilton, MD, PhD, University College, London; Study Chair: Elizabeth Murray, MD, PhD, University College, London

Publications and helpful links

General Publications

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
• 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/.
• Feeley N, Cossette S, Cote J, Heon M, Stremler R, Martorella G, Purden M. The importance of piloting an RCT intervention. Can J Nurs Res. 2009 Jun;41(2):85-99.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): July 28, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; mHealth; digital health; behavior change; mobile apps
• Other Study ID Numbers: 11121/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No