Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences (ENGAGE)
June 2, 2020 updated by: Mitesh Patel, University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Perelman Center for Advanced Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
Participants will receive daily performance feedback on their daily step count.
|
|
Experimental: 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
|
Participants will receive daily performance feedback on their daily step count.
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.
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.
|
|
Experimental: 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
|
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.
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.
|
|
Experimental: 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
|
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.
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.
|
|
Experimental: 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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mean daily steps from baseline to maintenance period.
Time Frame: Baseline to weeks 9-16
|
The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).
|
Baseline to weeks 9-16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mean daily steps from baseline to follow-up period.
Time Frame: Baseline to the weeks 17 to 24
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in minutes of MVPA from baseline to maintenance and follow-up periods.
Time Frame: Baseline to weeks 9-16 and weeks 17-24
|
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
|
|
Change in minutes of sleep from baseline to maintenance and follow-up periods.
Time Frame: Baseline to weeks 9-16 and weeks 17-24
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mitesh S Patel, MD, MBA, MS, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 14, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
November 14, 2018
First Submitted That Met QC Criteria
November 19, 2018
First Posted (Actual)
November 21, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 2, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 831258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be made available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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