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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03311230
Other study ID # 827508
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2017
Est. completion date March 18, 2019

Study information

Verified date February 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 602
Est. completion date March 18, 2019
Est. primary completion date January 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.
Competitive social incentive
Participants in this intervention will be competing against each other in the game.
Collaborative social incentive
Participants in this intervention will be working with each other in the game.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Deloitte

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mean Daily Steps Change in mean daily steps from baseline to main intervention period weeks 5 to 24 of the intervention
Secondary Change in Mean Daily Steps Change in mean daily steps from baseline through the follow-up period Weeks 25 to 36 of the follow-up period
Secondary Proportion of Participant-days That Step Goals Are Achieved proportion of days participants meet their step goal Weeks 5 to 24 of the main intervention period.
Secondary Proportion of Participant-days That Step Goals Are Achieved proportion of days participants meet their step goal Weeks 25 to 36 of the follow-up period.
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