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

Study Overview
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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.

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

Conditions
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Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Choice + Immediate
* Behavioral: Choice + Gradual
* Behavioral: Assigned + Immediate
* Behavioral: Assigned + Gradual
* Behavioral: Daily performance feedback
* Behavioral: Gamification


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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 | Behavioral: Daily performance feedback<br>* Participants will receive daily performance feedback on their daily step count.<br>|
| Experimental: Choice + Immediate<br>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 | Behavioral: Choice + Immediate<br>* 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.<br>Behavioral: Daily performance feedback<br>* Participants will receive daily performance feedback on their daily step count.<br>Behavioral: Gamification<br>* 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.<br>|
| Experimental: Choice + Gradual<br>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 | Behavioral: Choice + Gradual<br>* 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.<br>Behavioral: Daily performance feedback<br>* Participants will receive daily performance feedback on their daily step count.<br>Behavioral: Gamification<br>* 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.<br>|
| Experimental: Assigned + Immediate<br>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 | Behavioral: Assigned + Immediate<br>* 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.<br>Behavioral: Daily performance feedback<br>* Participants will receive daily performance feedback on their daily step count.<br>Behavioral: Gamification<br>* 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.<br>|
| Experimental: Assigned + Gradual<br>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 | Behavioral: Assigned + Gradual<br>* 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.<br>Behavioral: Daily performance feedback<br>* Participants will receive daily performance feedback on their daily step count.<br>Behavioral: Gamification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Goal-Setting, Gamification