NCT03565627

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

June 11, 2018

Last Update Submit

April 16, 2019

Conditions

Keywords

mHealthdigital healthbehavior changephysical activitymobile apps

Outcome Measures

Primary Outcomes (1)

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

    Determined by retention (%)

    Week 5

Secondary Outcomes (10)

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

    Week 5

  • Acceptability of the trial procedures and the interventions

    Week 5

  • Change in objectively measured PA from baseline to follow-up

    Week 3 and 5

  • The difference in PA change between the 2 apps

    Week 3 and 5

  • Change in self-reported PA

    Week 3 and 5

  • +5 more secondary outcomes

Study Arms (2)

Exercise app

EXPERIMENTAL

7 Minute Workout Challenge by Fitness Guide Inc.

Device: Exercise app: 7 Minute Workout Challenge

Running App

EXPERIMENTAL

One You Couch to 5K by Public Health England

Device: Running app: One You Couch to 5K

Interventions

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

Exercise app

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.

Running App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, NW3 2QG, United Kingdom

Location

Related Publications (3)

  • 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/.

    BACKGROUND
  • 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.

    PMID: 18824488BACKGROUND
  • 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.

    PMID: 19650515BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Fiona Hamilton, MD, PhD

    University College, London

    PRINCIPAL INVESTIGATOR
  • Elizabeth Murray, MD, PhD

    University College, London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 21, 2018

Study Start

January 5, 2018

Primary Completion

July 18, 2018

Study Completion

July 28, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations