Health BehaviorPhase 2/3PALNCT01575262
The Physical Activity Loyalty Card Scheme
A Phase 2/3 study testing Non-cash incentives and Self-monitoring physical activity levels in people with Health Behavior and Physical Activity, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effectiveness of using incentives to encourage adults to be physically active. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Physical Activity
- What is being tested?
- Non-cash incentives and Self-monitoring physical activity levels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Oct 2011
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and females
- aged 18-65 years old
- able to complete 15 minutes of moderate intensity physical activity
- based at least 4 days per week (and 6 hours per day) at worksite
Who cannot join
- advised by General Practitioner not to participate in exercise
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Antrim, BT12 6BJ
About this study
Official title: The Physical Activity Loyalty Card Scheme: A Randomised Controlled Trial to Encourage Physical Activity
The purpose of this study is to investigate the effectiveness of using incentives to encourage adults to be physically active.
Read the detailed description
The investigators developed the Physical Activity Loyalty Card (PAL) Scheme which integrates a novel physical activity tracking system with web-based monitoring and nudge initiatives. The tracking system used Near-Field Communication (NFC) technology and a "loyalty card" (PAL Card) which contained a passive Radio Frequency Identification (RFID) tag. Sensors were placed along footpaths in the outdoor environment, in the gym and exercise studio, and participants scanned their PAL card at the sensor when doing physical activity (e.g. walking). A transaction (card ID, sensor ID, and timestamp) was recorded and sent via SMS to a secure data centre. Participants logged onto a personal account on the study website (www.palcard.co.uk) and received real-time feedback on various aspects of their physical activity including minutes, distance and calories expended.
- Conditions
- Health Behavior, Physical Activity
- Being tested
- Non-cash incentives, Self-monitoring physical activity levels
- Keywords
- behaviour change, incentives, nudging, physical activity, self-monitoring
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cash incentivesBehavioural
Participants used their PAL card to self-monitor physical activity levels (intrinsic motivation) and minutes of physical activity were converted to points (1 minute of PA = 1 point; capped at 30 points per day) over the 12-week intervention period. Points were redeemed for rewards (extrinsic motivation) at week 6 and week 12.
Self-monitoring physical activity levelsBehavioural
For those in the 'No Incentive' arm, participants used their PAL card to self-monitor their physical activity levels but did not collect points or earn rewards.
| Study group | Role | What they receive |
|---|---|---|
| Incentive | Experimental | Participants use their PAL card to self-monitor physical activity levels (intrinsic motivation) and minutes of physical activity were converted to points (1 minute of physical activity = 1 point; capped at 30 points per day) over the 12-week intervention period. Points are redeemed for rewards (extrinsic motivation) at week 6 and week 12. Receives: Behavioral: Non-cash incentives |
| No Incentive | Active comparator | Participants used their PAL card to self-monitor their physical activity levels (intrinsic motivation) over the 12-week intervention period but do not collect points or earn rewards. Receives: Behavioral: Self-monitoring physical activity levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
change in moderate-vigorous physical activity (MVPA)measured using the Global Physical Activity Questionnaire (GPAQ); MVPA using an objective physical activity measure (physical activity tracking system)
Measured: baseline, week 12 and 6 months
Secondary outcomes (5)
SF-8
health
Measured: baseline, week 12 and 6 months
Euroqol 5D
Quality of life
Measured: baseline, week 12 and 6 months
Physical Activity Self-Efficacy Scale
Physical activity self-efficacy
Measured: baseline, week 12 and 6 months
Work absenteeism
Number of sick days from work
Measured: baseline, week 12 and 6 months
Exit questionnaire
Participant satisfaction with study involvement
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Frank Kee, Queen's University, Belfast
- Investigators
- Frank Kee, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575262
- Sponsor's protocol ID
- PAL-v1
- Acronym
- PAL
- Status last verified
- Apr 2012
- First submitted
- 10 Apr 2012
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physical Activity Loyalty Card Scheme: A Randomised Controlled Trial to Encourage Physical Activity
- ClinicalTrials.gov ID
- NCT01575262
- Acronym / sponsor ID
- PAL / PAL-v1
- Conditions
- Health Behavior, Physical Activity
- Keywords
- behaviour change, incentives, nudging, physical activity, self-monitoring
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of using incentives to encourage adults to be physically active.
Detailed description
The investigators developed the Physical Activity Loyalty Card (PAL) Scheme which integrates a novel physical activity tracking system with web-based monitoring and nudge initiatives. The tracking system used Near-Field Communication (NFC) technology and a "loyalty card" (PAL Card) which contained a passive Radio Frequency Identification (RFID) tag. Sensors were placed along footpaths in the outdoor environment, in the gym and exercise studio, and participants scanned their PAL card at the sensor when doing physical activity (e.g. walking). A transaction (card ID, sensor ID, and timestamp) was recorded and sent via SMS to a secure data centre. Participants logged onto a personal account on the study website (www.palcard.co.uk) and received real-time feedback on various aspects of their physical activity including minutes, distance and calories expended.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive | Experimental | Behavioral: Non-cash incentivesParticipants use their PAL card to self-monitor physical activity levels (intrinsic motivation) and minutes of physical activity were converted to points (1 minute of physical activity = 1 point; capped at 30 points per day) over the 12-week intervention period. Points are redeemed for rewards (extrinsic motivation) at week 6 and week 12. |
| No Incentive | Active comparator | Behavioral: Self-monitoring physical activity levelsParticipants used their PAL card to self-monitor their physical activity levels (intrinsic motivation) over the 12-week intervention period but do not collect points or earn rewards. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males and females
- aged 18-65 years old
- able to complete 15 minutes of moderate intensity physical activity
- based at least 4 days per week (and 6 hours per day) at worksite
Key exclusion criteria (1 listed)
- advised by General Practitioner not to participate in exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-cash incentivesParticipants used their PAL card to self-monitor physical activity levels (intrinsic motivation) and minutes of physical activity were converted to points (1 minute of PA = 1 point; capped at 30 points per day) over the 12-week intervention period. Points were redeemed for rewards (extrinsic motivation) at week 6 and week 12. | Behavioural | Incentive |
| Self-monitoring physical activity levelsFor those in the 'No Incentive' arm, participants used their PAL card to self-monitor their physical activity levels but did not collect points or earn rewards. | Behavioural | No Incentive |
Primary outcome
Physical activity
Time frame: baseline, week 12 and 6 months
change in moderate-vigorous physical activity (MVPA)measured using the Global Physical Activity Questionnaire (GPAQ); MVPA using an objective physical activity measure (physical activity tracking system)
5 secondary outcomes
SF-8
Time frame: baseline, week 12 and 6 months
Euroqol 5D
Time frame: baseline, week 12 and 6 months
Physical Activity Self-Efficacy Scale
Time frame: baseline, week 12 and 6 months
Work absenteeism
Time frame: baseline, week 12 and 6 months
Exit questionnaire
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Kee principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Non-cash incentives and Self-monitoring physical activity levels in people with Health Behavior and Physical Activity, run by Queen's University, Belfast 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 1 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 11 Apr 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical activity (time frame: baseline, week 12 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2012.