Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
ENGAGE
1 other identifier
interventional
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedStudy Start
First participant enrolled
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 4, 2020
June 1, 2020
1.4 years
November 14, 2018
June 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline to weeks 9-16
Secondary Outcomes (1)
Change in mean daily steps from baseline to follow-up period.
Baseline to the weeks 17 to 24
Other Outcomes (2)
Change in minutes of MVPA from baseline to maintenance and follow-up periods.
Baseline to weeks 9-16 and weeks 17-24
Change in minutes of sleep from baseline to maintenance and follow-up periods.
Baseline to weeks 9-16 and weeks 17-24
Study Arms (5)
Control
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
Interventions
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.
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.
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.
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.
Participants will receive daily performance feedback on their daily step count.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 34468691DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitesh S Patel, MD, MBA, MS
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 21, 2018
Study Start
January 14, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
June 4, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made available