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OpenTrials
Completed

NCT Number: NCT03749473

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Choice + Immediate

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.

Choice + Gradual

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.

Assigned + Immediate

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.

Assigned + Gradual

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

Behavioral

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

Gamification

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Other outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: ENGAGE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2018
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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