Atherosclerotic Cardiovascular DiseaseENGAGENCT03749473
Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
A study testing Choice + Immediate, Choice + Gradual and Assigned + Immediate in people with Atherosclerotic Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
To use a randomized controlled trial to test the effectiveness of four goal-setting strategies within a gamification intervention to increase physical activity among adults at elevated risk for ASCVD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Choice + Immediate, Choice + Gradual and Assigned + Immediate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- ability to read and provide informed consent to participate in the study;
- diagnosis of clinical ASCVD or a 10-year ASCVD risk score ≥ 7.5% calculated according to the 2013 ACC/AHA guidelines;
- Smartphone or tablet compatible with application for the wearable activity tracking device.
Who cannot join
- Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
- conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
- already enrolled in another study targeting physical activity;
- any other medical conditions or reasons he or she is unable to participate in a physical activity study for 24 weeks;
- baseline step count of 10,000 steps or greater.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
To use a randomized controlled trial to test the effectiveness of four goal-setting strategies within a gamification intervention to increase physical activity among adults at elevated risk for ASCVD.
Read the detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the United States. While increased physical activity can reduce this risk, less than half of adults in the United States meet the minimum recommendation guidelines for physical activity. Gamification, or the application of game design elements to non-game settings, has demonstrated promise in increasing physical activity when designed using insights from behavioral economics. However, the best way to design goal-setting within these interventions has not been well-examined. In this randomized controlled trial, the investigators will evaluate the effectiveness of four different goal-setting strategies within a gamification intervention to increase physical activity among adults with elevated risk for ASCVD. The trial will include a 2-week run-in period to estimate a baseline, followed by an 8-week introductory phase, an 8-week maintenance phase, and then after the intervention is completed an 8-week follow-up period.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Choice + Immediate, Choice + Gradual, Assigned + Immediate, Assigned + Gradual, Daily performance feedback
- Keywords
- Physical Activity, Goal-Setting, Gamification
- Medical subject headings
- Atherosclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice + ImmediateBehavioural
Participants in the choice + immediate goal arm will choose a step goal and must attempt to achieve this new step goal immediately at the start of the study.
Choice + GradualBehavioural
Participants in the choice + gradual goal arm will choose a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
Assigned + ImmediateBehavioural
Participants in the assigned + immediate goal arm will be assigned a step goal and must attempt to achieve this new step goal immediately at the start of the study.
Assigned + GradualBehavioural
Participants in the assigned + gradual goal arm will be assigned a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
Daily performance feedbackBehavioural
Participants will receive daily performance feedback on their daily step count.
GamificationBehavioural
All participants in the intervention arms will be entered into a gamification platform that has points and levels designed to incorporate insights from behavioral economics.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants receive a daily message with their step count on the prior day to serve as an active control for 24 weeks (daily performance feedback). No other interventions during the 24-week study Receives: Behavioral: Daily performance feedback |
| Choice + Immediate | Experimental | Participants choose a step goal between 1000-3000 steps greater than their baseline (choice). They are asked to reach their full step goal upon intervention start (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up Receives: Behavioral: Choice + Immediate; Behavioral: Daily performance feedback; Behavioral: Gamification |
| Choice + Gradual | Experimental | Participants are asked to choose a step goal between 1000-3000 steps greater than their baseline (choice). They will be asked to increase their step goal by even increments of 12.5% each week for the 8 weeks of the ramp-up period (gradual). After the 8-week ramp-up period, they will be asked to maintain the step goal for the study. They may change their goal within the range at anytime. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up Receives: Behavioral: Choice + Gradual; Behavioral: Daily performance feedback; Behavioral: Gamification |
| Assigned + Immediate | Experimental | Participants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to reach their full step goal as soon as the intervention begins (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up Receives: Behavioral: Assigned + Immediate; Behavioral: Daily performance feedback; Behavioral: Gamification |
| Assigned + Gradual | Experimental | Participants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to achieve their step goal of 2000 steps incrementally over the 8 weeks of the ramp-up period (gradual). After the first 8 weeks, they will be asked to maintain their full step goal of 2000 for the the study. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up Receives: Behavioral: Assigned + Gradual; Behavioral: Daily performance feedback; Behavioral: Gamification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daily steps from baseline to maintenance period.
The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).
Measured: Baseline to weeks 9-16
Secondary outcomes (1)
Change in mean daily steps from baseline to follow-up period.
The secondary outcome is change in mean daily steps from baseline to the weeks 17 to 24 (follow-up period).
Measured: Baseline to the weeks 17 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start14 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitesh Patel, University of Pennsylvania
- Investigators
- Mitesh S Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749473
- Sponsor's protocol ID
- 831258
- Acronym
- ENGAGE
- Status last verified
- Jun 2020
- First submitted
- 14 Nov 2018
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available
Publications
Patel MS, Bachireddy C, Small DS, Harrison JD, Harrington TO, Oon AL, Rareshide CAL, Snider CK, Volpp KG. Effect of Goal-Setting Approaches Within a Gamification Intervention to Increase Physical Activity Among Economically Disadvantaged Adults at Elevated Risk for Major Adverse Cardiovascular Events: The ENGAGE Randomized Clinical Trial. JAMA Cardiol. 2021 Dec 1;6(12):1387-1396. doi: 10.1001/jamacardio.2021.3176.
PubMed 34468691
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
- ClinicalTrials.gov ID
- NCT03749473
- Acronym / sponsor ID
- ENGAGE / 831258
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Physical Activity, Goal-Setting, Gamification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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.
To use a randomized controlled trial to test the effectiveness of four goal-setting strategies within a gamification intervention to increase physical activity among adults at elevated risk for ASCVD.
Detailed description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the United States. While increased physical activity can reduce this risk, less than half of adults in the United States meet the minimum recommendation guidelines for physical activity. Gamification, or the application of game design elements to non-game settings, has demonstrated promise in increasing physical activity when designed using insights from behavioral economics. However, the best way to design goal-setting within these interventions has not been well-examined. In this randomized controlled trial, the investigators will evaluate the effectiveness of four different goal-setting strategies within a gamification intervention to increase physical activity among adults with elevated risk for ASCVD. The trial will include a 2-week run-in period to estimate a baseline, followed by an 8-week introductory phase, an 8-week maintenance phase, and then after the intervention is completed an 8-week follow-up period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Daily performance feedbackParticipants receive a daily message with their step count on the prior day to serve as an active control for 24 weeks (daily performance feedback). No other interventions during the 24-week study |
| Choice + Immediate | Experimental | Behavioral: Choice + Immediate, Behavioral: Daily performance feedback, Behavioral: GamificationParticipants choose a step goal between 1000-3000 steps greater than their baseline (choice). They are asked to reach their full step goal upon intervention start (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up |
| Choice + Gradual | Experimental | Behavioral: Choice + Gradual, Behavioral: Daily performance feedback, Behavioral: GamificationParticipants are asked to choose a step goal between 1000-3000 steps greater than their baseline (choice). They will be asked to increase their step goal by even increments of 12.5% each week for the 8 weeks of the ramp-up period (gradual). After the 8-week ramp-up period, they will be asked to maintain the step goal for the study. They may change their goal within the range at anytime. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up |
| Assigned + Immediate | Experimental | Behavioral: Assigned + Immediate, Behavioral: Daily performance feedback, Behavioral: GamificationParticipants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to reach their full step goal as soon as the intervention begins (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up |
| Assigned + Gradual | Experimental | Behavioral: Assigned + Gradual, Behavioral: Daily performance feedback, Behavioral: GamificationParticipants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to achieve their step goal of 2000 steps incrementally over the 8 weeks of the ramp-up period (gradual). After the first 8 weeks, they will be asked to maintain their full step goal of 2000 for the the study. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- ability to read and provide informed consent to participate in the study;
- diagnosis of clinical ASCVD or a 10-year ASCVD risk score ≥ 7.5% calculated according to the 2013 ACC/AHA guidelines;
- Smartphone or tablet compatible with application for the wearable activity tracking device.
Key exclusion criteria (5 listed)
- Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
- conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
- already enrolled in another study targeting physical activity;
- any other medical conditions or reasons he or she is unable to participate in a physical activity study for 24 weeks;
- baseline step count of 10,000 steps or greater.
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 |
|---|---|---|
| Choice + ImmediateParticipants in the choice + immediate goal arm will choose a step goal and must attempt to achieve this new step goal immediately at the start of the study. | Behavioural | Choice + Immediate |
| Choice + GradualParticipants in the choice + gradual goal arm will choose a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study. | Behavioural | Choice + Gradual |
| Assigned + ImmediateParticipants in the assigned + immediate goal arm will be assigned a step goal and must attempt to achieve this new step goal immediately at the start of the study. | Behavioural | Assigned + Immediate |
| Assigned + GradualParticipants in the assigned + gradual goal arm will be assigned a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study. | Behavioural | Assigned + Gradual |
| Daily performance feedbackParticipants will receive daily performance feedback on their daily step count. | Behavioural | Assigned + Gradual, Assigned + Immediate, Choice + Gradual, Choice + Immediate, Control |
| GamificationAll participants in the intervention arms will be entered into a gamification platform that has points and levels designed to incorporate insights from behavioral economics. | Behavioural | Assigned + Gradual, Assigned + Immediate, Choice + Gradual, Choice + Immediate |
Primary outcome
Change in mean daily steps from baseline to maintenance period.
Time frame: Baseline to weeks 9-16
The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).
1 secondary outcome
Change in mean daily steps from baseline to follow-up period.
Time frame: Baseline to the weeks 17 to 24
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 4 Jun 2020.
- Derived from this study: PubMed 34468691Patel MS, Bachireddy C, Small DS, Harrison JD, Harrington TO, Oon AL, Rareshide CAL, Snider CK, Volpp KG. Effect of Goal-Setting Approaches Within a Gamification Intervention to Increase Physical Activity Among Economically Disadvantaged Adults at Elevated Risk for Major Adverse Cardiovascular Events: The ENGAGE Randomized Clinical Trial. JAMA Cardiol. 2021 Dec 1;6(12):1387-1396. doi: 10.1001/jamacardio.2021.3176.
- Individual participant dataSharing planned: No. Individual participant data will not be made available
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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.
Mitesh S Patel, MD, MBA, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choice + Immediate, Choice + Gradual and Assigned + Immediate in people with Atherosclerotic Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.
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 5 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 4 Jun 2020. 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 States. 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.
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?
Change in mean daily steps from baseline to maintenance period. (time frame: Baseline to weeks 9-16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749473, which also lists 1 linked publication.
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 4 Jun 2020.