Clinical trial NCT03749473: Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
Official title: Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerotic Cardiovascular Disease
Keywords: Physical Activity
Goal-Setting
Gamification
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in mean daily steps from baseline to maintenance period.
timeFrame: Baseline to weeks 9-16
Secondary outcomes:
measure: Change in mean daily steps from baseline to follow-up period.
timeFrame: Baseline to the weeks 17 to 24
Other outcomes:
measure: Change in minutes of MVPA from baseline to maintenance and follow-up periods.
timeFrame: Baseline to weeks 9-16 and weeks 17-24
measure: Change in minutes of sleep from baseline to maintenance and follow-up periods.
timeFrame: Baseline to weeks 9-16 and weeks 17-24
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh S Patel, MD, MBA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.