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

NCT ID: NCT03749473

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-06-01

Brief Summary

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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

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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

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Daily performance feedback

Intervention Type BEHAVIORAL

Participants will receive daily performance feedback on their daily step count.

Choice + Immediate

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

Group Type EXPERIMENTAL

Choice + Immediate

Intervention Type BEHAVIORAL

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.

Daily performance feedback

Intervention Type BEHAVIORAL

Participants will receive daily performance feedback on their daily step count.

Gamification

Intervention Type BEHAVIORAL

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.

Choice + Gradual

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

Group Type EXPERIMENTAL

Choice + Gradual

Intervention Type BEHAVIORAL

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.

Daily performance feedback

Intervention Type BEHAVIORAL

Participants will receive daily performance feedback on their daily step count.

Gamification

Intervention Type BEHAVIORAL

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.

Assigned + Immediate

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

Group Type EXPERIMENTAL

Assigned + Immediate

Intervention Type BEHAVIORAL

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.

Daily performance feedback

Intervention Type BEHAVIORAL

Participants will receive daily performance feedback on their daily step count.

Gamification

Intervention Type BEHAVIORAL

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.

Assigned + Gradual

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

Group Type EXPERIMENTAL

Assigned + Gradual

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Participants will receive daily performance feedback on their daily step count.

Gamification

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Daily performance feedback

Participants will receive daily performance feedback on their daily step count.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Mitesh Patel

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitesh S Patel, MD, MBA, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34468691 (View on PubMed)

Other Identifiers

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831258

Identifier Type: -

Identifier Source: org_study_id

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