Plain English Summary
Background and study aims
Increasing participation in physical activity is a great way to improve public health. The Government recommends that all adults should do a minimum of 150 minutes of physical activity every week. Past attempts to increase physical activity have not been very effective. Most adults spend a large part of their time at work, so this is a good place to promote programmes of physical activity that could encourage a longer term, habitual increase in activity. The Government is encouraging the use of incentives for promoting healthy lifestyles, but little is known about how effective they are. We have developed a new physical activity loyalty card which works in the same way as well-known high street loyalty cards, where participants earn points and receive rewards for repeatedly shopping in a particular store. Our scheme uses sensors placed along footpaths, the nearby local park, leisure centre, shopping mall, bus stops and train stations, and a small loyalty card. When users go for a walk, they swipe their card across the sensors and information is collected on the time that the card was scanned, sent to our study website and processed. Participants can then log onto their own account to get feedback on their activity. They earn 10 points for each minute of activity that they complete and can exchange the collected points for vouchers (e.g. free cinema pass, free sandwich voucher) that have been sponsored by local retailers. We have already tested this scheme with a group of civil servants to confirm that the technology worked, people were very interested to take part, the method has the potential to increase physical activity and local businesses will sponsor the rewards. The next stage is to do a larger study to find out if the difference the scheme can make to peoples health would be worthwhile.
Who can participate?
We will recruit about 1400 employees within large public sector organisations in Lisburn, Northern Ireland.
What does the study involve?
Participants will be randomly allocated to take part in this intervention immediately or would be given the opportunity to participate in the scheme at the end of the study. The study will show whether the intervention leads to increased physical activity levels after 6 months and if this effect is maintained 1 year after the programme ends. Participants will be asked to wear a small pedometer (worn on their waist) to measure the number of steps they take over 7 days. We will also look at the effects of the intervention on health, mental wellbeing, quality of life, absence from work and use of healthcare facilities using questionnaires. At the end of the intervention we will invite participants, senior managers from participating organisations and retailers to attend discussion groups, to give us their views about the intervention.
What are the possible benefits and risks of participating?
Possible benefits for participants include an increase in physical activity levels and thereby benefitting physical health, mental wellbeing and quality of life. For the employer, potential benefits include reduced absenteeism levels and associated cost benefits. There are no expected risks to participating.
Where is the study run from?
The study include large public sector organisations in Lisburn City Centre (Northern Ireland)
When is the study starting and how long is it expected to run for?
September 2014 to February 2018
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Frank Kee
f.kee@qub.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Frank Kee
ORCID ID
Contact details
UKCRC Centre of Excellence for Public Health (NI)
Queen's University Belfast
Institute of Clinical Science B
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 (0)28 9063 5009
f.kee@qub.ac.uk
Additional identifiers
EudraCT number
N/A
ClinicalTrials.gov number
N/A
Protocol/serial number
1.0
Study information
Scientific title
Effectiveness and cost-effectiveness of a Physical Activity Loyalty scheme to maintain behaviour change: a cluster randomised controlled trial
Acronym
PAL scheme
Study hypothesis
The proposed cluster randomised controlled trial (RCT) has the following objectives:
1. To investigate the effectiveness of the PAL Scheme to increase employees PA levels in an office-based occupational setting
2. To investigate if any change in PA behaviour is maintained over time
3. To conduct cost-effectiveness and cost-benefit type analyses of the PAL Scheme
4. To investigate how the intervention impacts on other health behaviours and outcomes
5. To investigate wider work-related effects including sickness absenteeism and work presenteeism
6. To investigate the mediators of (a) uptake and use of the loyalty card, (b) initiation, and (c) maintenance of behaviour change
7. To conduct a parallel qualitative study to further characterize those who benefitted from the intervention, how and why it worked for them, and explore mediators of behaviour change
8. To conduct a Discrete Choice Experiment (DCE) to investigate the possible optimal levels of incentives for such interventions
9. To conduct a behavioural economic field experiment on inter-temporal preferences to investigate the relationship between behavioural change, discounting and incentives
Ethics approval
Office for Research Ethics Committees Northern Ireland (ORECNI) HSC REC B; REC ref: 14/NI/0090
Study design
Cluster randomised controlled trial will evaluate the PAL scheme, incorporating nested behavioural economic experiments, and process evaluation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Predominantly sedentary, office-based public sector employees
Intervention
Intervention Group: The study will involve the implementation of a multi-component intervention (PAL Scheme) which includes provision of points and rewards (financial incentives) contingent on meeting targeted behaviour goals (physical activity). Participants will be encouraged to undertake 150 mins/week of physical activity which is in line with current guidelines. The PAL scheme integrates a novel physical activity tracking system with web-based monitoring and evidence-based behaviour change tools. The tracking system uses Near-Field Communication (NFC) technology and a loyalty card (PAL Card) which contains a passive Radio Frequency Identification (RFID) tag to monitor participants' physical activity as part of the intervention. Participants swipe their PAL card at sensors when undertaking physical activity (e.g. walking) which logs the place, date and time of the card scan. Participants log onto their account on the study website and receive real-time feedback on aspects of their physical activity, including minutes of activity. Minutes will be converted to points (10 points for 1 minute of activity recorded), and collected points are redeemed for rewards (retail vouchers) sponsored by, and redeemable at, local businesses. The intervention is underpinned by the principles of Learning Theory and Social Cognitive Theory.
Control Group: Those assigned to the control condition (n=690) will constitute a waiting list Control Group and will be offered the opportunity to participate in the intervention after the 18-month follow-up period. Participants in this group will complete outcome measures at the same time points as the Intervention Group.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Mean steps/day objectively measured by a sealed pedometer (to blind participants to the output) worn on the waistband (Yamax Digiwalker CW-701, Japan), for which reliability and validity has been established
Secondary outcome measures
1. Health and Wellbeing: health [Short Form-8 (SF-8)]
2. Quality of Life (EQ-5D-5L)
3. Mental well-being [Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)]
4. Work-related Impacts: Work absenteeism and presenteeism will be measured using the WHO Health and Work Performance Questionnaire.
5. Mediators: We will collect data that are hypothesised to mediate loyalty card use, initiation and maintenance of PA behaviour, including outcome expectancy, social norms, self-efficacy, intention, perceptions of workplace environment, access to physical activity opportunities.
Overall trial start date
01/09/2014
Overall trial end date
28/02/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Potential participants will be asked to complete a screening questionnaire via the study website or by telephone, to confirm their eligibility, based on the following inclusion criteria:
1. Based at recruited worksite at least 4 hours/day (within core hours of 8am-6pm) and 3 days/week
2. Current contract lasts for duration of the study (i.e.18 months) (this is to exclude temporary workers)
3. Access to internet at work
4. Able to give informed consent
5. Able to communicate in English
6. No self-reported recent history of myocardial infarction or stroke or physical limitations that would limit ability to participate in physical activity (assessed using the Physical Activity Readiness Questionnaire)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1380
Total final enrolment
853
Participant exclusion criteria
1. Based at worksite less than 4 hours/day and/or outside of core working hours of 8am-6pm, and less than 3 days/week
2. Current contract lasts less than the duration of the study
3. No access to internet at work
4. Unable to provide informed consent
5. Unable to communicate in English
6. Self-reported recent history of myocardial infarction or stroke or physical limitations that would limit ability to participate in physical activity (assessed using the Physical Activity Readiness Questionnaire)
Recruitment start date
01/09/2014
Recruitment end date
28/02/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's University Belfast
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Queen's University Belfast (UK)
Sponsor details
Research Governance
63 University Road
Belfast
BT7 1NN
United Kingdom
+44 (0)28 9097 2572
l.h.dunlop@qub.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) (12/211/82)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
N/A
Publication list
1. 2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27448663
2. 2018 effectiveness and cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/30541563
3. 2019 engagement results in: https://www.ncbi.nlm.nih.gov/pubmed/31002304 (added 23/04/2019)