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Social Incentives To Encourage Physical Activity and Understand Predictors (STEPUP)

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ClinicalTrials.gov Identifier: NCT03311230
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Deloitte
Information provided by (Responsible Party):
Mitesh Patel, University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Supportive social incentive Behavioral: Competitive social incentive Behavioral: Collaborative social incentive Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Social Incentives To Encourage Physical Activity and Understand Predictors
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : March 18, 2019

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.
Behavioral: Supportive social incentive
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.
Behavioral: Competitive social incentive
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
Behavioral: Collaborative social incentive
Participants in this intervention will be working with each other in the game.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older;
  2. ability to read and provide informed consent to participate in the study;
  3. Self-reported body mass index (BMI) of 25 or greater.
  4. Smartphone or tablet compatible with application for the wearable activity tracking device.

Exclusion Criteria:

  1. Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
  2. conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
  3. already enrolled in another study targeting physical activity;
  4. any other medical conditions or reasons he or she is unable to participate in a physical activity study for 36 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311230


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Deloitte
Investigators
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Principal Investigator: Mitesh Patel, MD, MBA, MS University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mitesh Patel, Mitesh S. Patel, Director, Penn Medicine Nudge Unit, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03311230     History of Changes
Other Study ID Numbers: 827508
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No