Feasibility, Acceptability and the Effects of Two Publicl... | NCT03565627

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

NCT03565627

Sponsor

University College, London

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

PHYSICAL FITNESS

Interventions

Exercise app: 7 Minute Workout Challenge
Running app: One You Couch to 5K

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2018Actual

Primary Completion Date

Jul 18, 2018Actual

Completion Date

Jul 28, 2018Actual

First Submitted Date

Jun 11, 2018

First Submission Date that Met QC Criteria

Jun 20, 2018

First Posted Date

Jun 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Name	Class
Medical Research Council	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exercise app: 7 Minute Workout Challenge	Device	7 Minute Workout Challenge by Fitness Guide Inc. combines aerobic and resistance training into short, 7 minute high intensity circuit training.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fiona Hamilton, MD, PhD	University College, London	Principal Investigator
Elizabeth Murray, MD, PhD	University College, London	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
eHealth Unit, Research Department of Primary Care and Population Health, University College London		London		NW3 2QG	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation
	Background	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/.
18824488	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.
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