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PHYSICAL FITNESSNCT03565627

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

A study testing Exercise app: 7 Minute Workout Challenge and Running app: One You Couch to 5K in people with PHYSICAL FITNESS, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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]. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
PHYSICAL FITNESS
What is being tested?
Exercise app: 7 Minute Workout Challenge and Running app: One You Couch to 5K
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited Kingdom
Study dates
5 Jan 2018to 28 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

    London, NW3 2QG

Other trials in United Kingdom

About this study

Official title: 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

Read the 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.

Being tested
Exercise app: 7 Minute Workout Challenge, Running app: One You Couch to 5K
Keywords
mHealth, digital health, behavior change, physical activity, mobile apps
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise app: 7 Minute Workout ChallengeDevice

    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 5KDevice

    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.

Study groups in NCT03565627
Study groupRoleWhat they receive
Exercise appExperimental7 Minute Workout Challenge by Fitness Guide Inc.
Receives: Device: Exercise app: 7 Minute Workout Challenge
Running AppExperimentalOne You Couch to 5K by Public Health England
Receives: Device: Running app: One You Couch to 5K

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Determined by retention (%)

    Measured: Week 5

Secondary outcomes (10)

  1. Retention measured by completeness of data at 5 weeks' follow up

    Determined by retention (%)

    Measured: Week 5

  2. Acceptability of the trial procedures and the interventions

    Semi-structured interviews following the completion of the trial

    Measured: Week 5

  3. Change in objectively measured PA from baseline to follow-up

    Measured by hip-worn ActiGraph GT3X+

    Measured: Week 3 and 5

  4. The difference in PA change between the 2 apps

    Measured by hip-worn ActiGraph GT3X+

    Measured: Week 3 and 5

  5. Change in self-reported PA

    Using International Physical Activity Questionnaires: short last 7 days self-administered format

    Measured: Week 3 and 5

  6. Change in exercise self-efficacy

    Measured using Self-Efficacy to Regulate Exercise

    Measured: Week 3 and 5

  7. Change in PA outcome expectancy measure

    Assessed using Physical Activity Outcome Expectancy Measure

    Measured: Week 3 and 5

  8. Usability of the apps

    Assessed using System Usability Scale

    Measured: Week 3 and 5

  9. Change in mood

    Assessed daily using PACO app

    Measured: Week 5

  10. 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

    Measured: Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2018
  2. Study start5 Jan 2018
  3. Primary completion18 Jul 2018
  4. Study completion28 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03565627
Sponsor's protocol ID
11121/001
Status last verified
Apr 2019
First submitted
11 Jun 2018
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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/.

  • 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.

    PubMed 18824488

  • 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.

    PubMed 19650515

Questions about this trial

What is this clinical trial studying?

A study testing Exercise app: 7 Minute Workout Challenge and Running app: One You Couch to 5K in people with PHYSICAL FITNESS, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rates as a percentage of eligible participants that consented to partake in the study (time frame: Week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03565627, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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