Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences

Atherosclerotic Cardiovascular Disease Clinical Trial

— ENGAGE  

Official title:

Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749473
• Other study ID #: 831258
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Choice + Immediate
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 + Gradual
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 + Immediate
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 + Gradual
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 feedback
Participants will receive daily performance feedback on their daily step count.
• Gamification
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.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in minutes of MVPA from baseline to maintenance and follow-up periods.	An exploratory outcome is change in minutes of moderate-to-vigorous physical activity (MVPA) from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).	Baseline to weeks 9-16 and weeks 17-24
Other	Change in minutes of sleep from baseline to maintenance and follow-up periods.	An exploratory outcome is change in minutes of sleep from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).	Baseline to weeks 9-16 and weeks 17-24
Primary	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	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).	Baseline to the weeks 17 to 24