- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03311230
Social Incentives To Encourage Physical Activity and Understand Predictors (STEPUP)
February 13, 2020 updated by: Mitesh Patel, University of Pennsylvania
This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week follow-up period.
Participants are considered ready to be randomized once they have completed all surveys, established a baseline step count, and selected a step goal increase.Participants in the control arm will receive no other interventions during the 24-week intervention period or the 12-week follow-up period.
Participants randomized to the one of the three intervention arms will have a 4-week ramp up towards their step goal.
The participant will then be asked to maintain their goal during the 20-week "maintenance period" and the 12-week "follow-up period."
Participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics.
Participants in the supportive social incentive arm will be asked to identify a family member or friend to be their support sponsor.
This sponsor will be encouraged to support the participant in their progress during the study.
Participants in the competitive social incentive arm will be in a group of three total participants.At the end of each week the participants will receive notification that ranks them on their cumulative points in the study thus far and also displays their level.This feedback may help to induce participants to compete for the top spot among the group.
Participants in the collaborative social incentive arm will be in a group of three total participants as a team.
Each day one of the members of the group will be randomly selected to represent their team for that day.
In this design, each person is accountable to the others on the team and this may induce a collaborative effort to meet their daily goals.
Study Type
Interventional
Enrollment (Actual)
602
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
- University of Pennsylvania
-
-
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
No
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;
- Self-reported body mass index (BMI) of 25 or greater.
- 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 36 weeks.
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 |
---|---|
No Intervention: Control
Participants in this arm will receive no other interventions during the 9 month study period
|
|
Experimental: Supportive social incentive
Participants will identify a family member or friend to support them during a gamification intervention.
|
A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
|
Experimental: Competitive social incentive
Participants will compete in a gamification intervention in groups of three.
|
Participants in this intervention will be competing against each other in the game.
|
Experimental: Collaborative social incentive
Participants will collaborate in groups of three in a gamification intervention
|
Participants in this intervention will be working with each other in the game.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Daily Steps
Time Frame: weeks 5 to 24 of the intervention
|
Change in mean daily steps from baseline to main intervention period
|
weeks 5 to 24 of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Daily Steps
Time Frame: Weeks 25 to 36 of the follow-up period
|
Change in mean daily steps from baseline through the follow-up period
|
Weeks 25 to 36 of the follow-up period
|
Proportion of Participant-days That Step Goals Are Achieved
Time Frame: Weeks 5 to 24 of the main intervention period.
|
proportion of days participants meet their step goal
|
Weeks 5 to 24 of the main intervention period.
|
Proportion of Participant-days That Step Goals Are Achieved
Time Frame: Weeks 25 to 36 of the follow-up period.
|
proportion of days participants meet their step goal
|
Weeks 25 to 36 of the follow-up period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
General Publications
- Lewey J, Murphy S, Zhang D, Putt ME, Elovitz MA, Riis V, Patel MS, Levine LD. Effectiveness of a Text-Based Gamification Intervention to Improve Physical Activity Among Postpartum Individuals With Hypertensive Disorders of Pregnancy: A Randomized Clinical Trial. JAMA Cardiol. 2022 Jun 1;7(6):591-599. doi: 10.1001/jamacardio.2022.0553.
- Rewley J, Guszcza J, Dierst-Davies R, Steier D, Szwartz G, Patel M. Loss Aversion Explains Physical Activity Changes in a Behavioral Gamification Trial. Games Health J. 2021 Dec;10(6):430-436. doi: 10.1089/g4h.2021.0130.
- Patel MS, Small DS, Harrison JD, Fortunato MP, Oon AL, Rareshide CAL, Reh G, Szwartz G, Guszcza J, Steier D, Kalra P, Hilbert V. Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1624-1632. doi: 10.1001/jamainternmed.2019.3505.
- Harrison JD, Jones JM, Small DS, Rareshide CAL, Szwartz G, Steier D, Guszcza J, Kalra P, Torio B, Reh G, Hilbert V, Patel MS. Social incentives to encourage physical activity and understand predictors (STEP UP): Design and rationale of a randomized trial among overweight and obese adults across the United States. Contemp Clin Trials. 2019 May;80:55-60. doi: 10.1016/j.cct.2019.04.001. Epub 2019 Apr 4.
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)
October 30, 2017
Primary Completion (Actual)
January 7, 2019
Study Completion (Actual)
March 18, 2019
Study Registration Dates
First Submitted
October 11, 2017
First Submitted That Met QC Criteria
October 11, 2017
First Posted (Actual)
October 17, 2017
Study Record Updates
Last Update Posted (Actual)
March 2, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 827508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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