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

Primary Purpose

Atherosclerotic Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choice + Immediate
Choice + Gradual
Assigned + Immediate
Assigned + Gradual
Daily performance feedback
Gamification
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atherosclerotic Cardiovascular Disease focused on measuring Physical Activity, Goal-Setting, Gamification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Perelman Center for Advanced Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Choice + Immediate

Choice + Gradual

Assigned + Immediate

Assigned + Gradual

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
November 14, 2018
Last Updated
June 2, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03749473
Brief Title
Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
Acronym
ENGAGE
Official Title
Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease
Keywords
Physical Activity, Goal-Setting, Gamification

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Choice + Immediate
Arm Type
Experimental
Arm Description
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
Arm Title
Choice + Gradual
Arm Type
Experimental
Arm Description
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
Arm Title
Assigned + Immediate
Arm Type
Experimental
Arm Description
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
Arm Title
Assigned + Gradual
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Choice + Immediate
Intervention Description
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
Intervention Name(s)
Choice + Gradual
Intervention Description
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
Intervention Name(s)
Assigned + Immediate
Intervention Description
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
Intervention Name(s)
Assigned + Gradual
Intervention Description
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
Intervention Name(s)
Daily performance feedback
Intervention Description
Participants will receive daily performance feedback on their daily step count.
Intervention Type
Behavioral
Intervention Name(s)
Gamification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean daily steps from baseline to maintenance period.
Description
The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).
Time Frame
Baseline to weeks 9-16
Secondary Outcome Measure Information:
Title
Change in mean daily steps from baseline to follow-up period.
Description
The secondary outcome is change in mean daily steps from baseline to the weeks 17 to 24 (follow-up period).
Time Frame
Baseline to the weeks 17 to 24
Other Pre-specified Outcome Measures:
Title
Change in minutes of MVPA from baseline to maintenance and follow-up periods.
Description
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).
Time Frame
Baseline to weeks 9-16 and weeks 17-24
Title
Change in minutes of sleep from baseline to maintenance and follow-up periods.
Description
An exploratory outcome is change in minutes of sleep from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).
Time Frame
Baseline to weeks 9-16 and weeks 17-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh S Patel, MD, MBA, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available
Citations:
PubMed Identifier
34468691
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.
Results Reference
derived

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

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