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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

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 17, 2017
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE October 30, 2017
Actual Primary Completion Date January 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03311230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Incentives To Encourage Physical Activity and Understand Predictors
Official Title  ICMJE Social Incentives To Encourage Physical Activity and Understand Predictors
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • Behavioral: Competitive social incentive
    Participants in this intervention will be competing against each other in the game.
  • Behavioral: Collaborative social incentive
    Participants in this intervention will be working with each other in the game.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Supportive social incentive
  • Experimental: Competitive social incentive
    Participants will compete in a gamification intervention in groups of three.
    Intervention: Behavioral: Competitive social incentive
  • Experimental: Collaborative social incentive
    Participants will collaborate in groups of three in a gamification intervention
    Intervention: Behavioral: Collaborative social incentive
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)
602
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2017)
600
Actual Study Completion Date  ICMJE March 18, 2019
Actual Primary Completion Date January 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03311230
Other Study ID Numbers  ICMJE 827508
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mitesh Patel, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Deloitte
Investigators  ICMJE
Principal Investigator: Mitesh Patel, MD, MBA, MS University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP