Condition category
Mental and Behavioural Disorders
Date applied
11/07/2012
Date assigned
01/08/2012
Last edited
27/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Increasing levels of obesity and diabetes to name a few health concerns have prompted governments into promoting regular physical activity as an essential tool to improve your health. New accelerometer-based technology which is standard in smartphones facilitates the monitoring of physical activity, but as of yet there is no data to indicate whether it actually leads to increased levels of physical activity. The aim of this study is evaluate whether the use of smartphone technology promotes physical activity and improves associated health outcomes.

Who can participate?
Adults over the age of 16 with a sedentary (inactive) lifestyle, who are Android smartphone users.

What does the study involve?
A pedometer application is installed on the participants’ smartphones to record their physical activity (e.g., step count). The first part of the study will consist of a 7-day run-in period during which the participants will be asked not to change their usual physical activity habits, allowing the team to calculate a baseline average step count. Participants are then randomly allocated to one of two groups: the intervention group or the control group. The control group is asked to carry on their daily activity as per normal but to walk an additional 30 minutes per day. The intervention group is told how to use the app and is instructed to reach the goal of 10,000 steps per day.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
North Clare Primary Care Network (Ireland).

When is the study starting and how long is it expected to run for?
August 2012 to August 2013.

Who is funding the study?
This study is funded as part of the Implementing Transnational Telemedicine Solutions (ITTS) research programme which is funded under the EU Northern Periphery Project (NPP).

Who is the main contact?
Dr Liam Glynn
liamglynn@nuigalway.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Liam Glynn

ORCID ID

Contact details

Discipline of General Practice
College of Medicine
Nursing and Health Sciences
National University of Ireland Galway
Galway
N/A
Ireland
+353 (0)91 512438
liam.glynn@nuigalway.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of a smartphone-based intervention to promote physical activity in primary care

Acronym

SMART MOVE

Study hypothesis

Of all types of physical activity, walking is the most commonly encouraged, most commonly reported form of leisure physical activity. Pedometers which contain accelerometers have become the most acceptable form of device for monitoring walking. This trial is investigating a pedometer-based walking intervention in combination with Smartphone-based technology and smartphone-based pedometer applications. Effectivily the Smartphone will replace the pedometer and is the primary source of data collection/step count during the trial period.

Aims:
1. An increase in step count per day compared to baseline step count.
2. Improved physiological and mental health scores i.e. reduction in weight BMI, blood pressure, resting heart rate and improved mental health results using Hospital Anxiety and Depression Scale (HADS) and Quality of Life (EQOL) questionnaire.

Ethics approval

Clinical Research Ethics Committee, Galway, Health Service Executive of Ireland

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smartphone for positive behavioural change/promotion of physical activity

Intervention

Screening/Baseline visit and run in period

All potential participants will be screened by a GP. The clinician will deem that a participant is in suitable physical health to undertake moderate physical activity. The participant will be invited to attend a screening/baseline meeting with 2 researchers. After obtaining a written informed consent, baseline data will be gathered by a research nurse.

Eligible participants will meet with a research engineer where the software app will be installed on the persons privately owned Smartphone with their consent. During the run in baseline period the pedometer application will be set to record and store physical activity e.g. step count. No widget (Smartphone screen display) or step count will be displayed or visible. In order to standardize the recordings participants are asked to position the Smartphone in there trouser/pants pocket or on their waistband or belt and only remove it during times of sleep and showering.

The run in period will allow the team to identify a baseline average step count and confirm if the participant has sufficient Smartphone and computer literacy to successfully complete the trail period. The initial part of the protocol will consist of a 7-day baseline period during which the participants will be asked not to change their usual physical activity habits

Control Group
The control group will be contacted by mobile phone and asked to email their run in step count data. Once week one run in is deemed successful. Each member of the control group will be contacted by phone and:
1. Instructed to carry on daily activity as per normal but in addition instructed to walk an additional 30 minutes per day.
2. Advised on how to maintain the performance of the phone such as charging and constant carrying of the phone on their person.
3. Issued by post or electronically with Irish Heart Foundation 'Be Active' promotional brochure.
4. Contacted mid study session by telephone/text or email and asked to forward step count details. This is an attempt to reduce data/user error whereby the step count can be verified and the application confirmed to be working effectively.

Intervention Group
The intervention group will be contacted by mobile phone and asked to email their run in step count data. Once week one run in is deemed successful,
Each member of the control group will be contacted by phone and:
1. Instructed how to turn on the Accupedo widget or display and how to position the display on the home screen providing up to minute information of step count to date.
Instructed on usability of the Accupedo settings, graphs, and email and user interface.
2. Encouraged to interact with the smartphone pedometer app.
3. Instructed to achieve 10000 steps per day goal.
4. Issued by post or electronically with Irish Heart Foundation 'Be Active' promotional brochure.
5. Contacted mid study session by telephone/text or email and asked to forward step count details. This is an attempt to reduce data/user error whereby the step count can be verified and the application confirmed to be working effectively.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Mean daily step count compared to baseline

Secondary outcome measures

Physiological and mental health scores, i.e. weight, body mass index (BMI), blood pressure, resting heart rate, and mental health results using HADS and EQOL questionnaire.

Overall trial start date

07/08/2012

Overall trial end date

07/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults over the age of 16 with sedentary lifestyle
2. Are active Android smartphone users

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 (40 intervention and 40 control)

Participant exclusion criteria

1. People with learning disabilities
2. Acute psychiatric illness
3. Pregnant women
4. People with mobility issues

Recruitment start date

07/08/2012

Recruitment end date

07/08/2013

Locations

Countries of recruitment

Ireland

Trial participating centre

National University of Ireland Galway
Galway
N/A
Ireland

Sponsor information

Organisation

Implementing Transnational Telemedicine Solutions [ITTS] (UK)

Sponsor details

University of Aberdeen
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
+44 (0)1463 255890
e.coats@abdn.ac.uk

Sponsor type

University/education

Website

http://www.transnational-telemedicine.eu/

Funders

Funder type

Research organisation

Funder name

Northern Periphery Programme (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Implementing Transnational Telemedicine Solutions [ITTS] (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23714362
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24982490

Publication citations

  1. Protocol

    Glynn LG, Hayes PS, Casey M, Glynn F, Alvarez-Iglesias A, Newell J, Ólaighin G, Heaney D, Murphy AW, SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial., Trials, 2013, 14, 157, doi: 10.1186/1745-6215-14-157.

  2. Results

    Glynn LG, Hayes PS, Casey M, Glynn F, Alvarez-Iglesias A, Newell J, OLaighin G, Heaney D, O'Donnell M, Murphy AW, Effectiveness of a smartphone application to promote physical activity in primary care: the SMART MOVE randomised controlled trial, Br J Gen Pract, 2014, 64, 624, e384-e391, doi: 10.3399/bjgp14X680461.

Additional files

Editorial Notes