Clinical trial NCT03565627: Feasibility, Acceptability and the Effects of Two Publicly Available Physical Activity Mobile Apps
Official title: The Feasibility and Acceptability of a Randomised Crossover Trial Assessing Two Current Health Apps for Increasing Physical Activity: a Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PHYSICAL FITNESS
Keywords: mHealth
digital health
behavior change
physical activity
mobile apps
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2018-06-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Recruitment rates as a percentage of eligible participants that consented to partake in the study
timeFrame: Week 5
Secondary outcomes:
measure: Retention measured by completeness of data at 5 weeks' follow up
timeFrame: Week 5
measure: Acceptability of the trial procedures and the interventions
timeFrame: Week 5
measure: Change in objectively measured PA from baseline to follow-up
timeFrame: Week 3 and 5
measure: The difference in PA change between the 2 apps
timeFrame: Week 3 and 5
measure: Change in self-reported PA
timeFrame: Week 3 and 5
measure: Change in exercise self-efficacy
timeFrame: Week 3 and 5
measure: Change in PA outcome expectancy measure
timeFrame: Week 3 and 5
measure: Usability of the apps
timeFrame: Week 3 and 5
measure: Change in mood
timeFrame: Week 5
measure: Usage of apps
timeFrame: Week 13
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: eHealth Unit, Research Department of Primary Care and Population Health, University College London
Study officials:
affiliation: University College, London
name: Fiona Hamilton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Elizabeth Murray, MD, PhD
role: STUDY_CHAIR
References:
citation: 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/.
citation: 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.
citation: 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.