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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03563027
Other study ID # CDX 18-003
Secondary ID HX-001922-01
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2019
Est. completion date August 9, 2020

Study information

Verified date August 2021
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this randomized, controlled trial the investigators will compare the use of social and financial incentive-based interventions to increase physical activity among overweight and obese Veterans during a 12-week intervention with 8 weeks of follow-up.


Description:

In this 3-arm randomized trial, the investigators will compare the effectiveness of a social incentive-based gamification intervention with and without loss-framed financial incentives to increase physical activity relative to a control among overweight and obese adults Veterans. All Veterans will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above baseline and then participate in a 12-week intervention and 8-week follow-up period. The two intervention arms will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game. Veterans in one arm will also receive loss-framed financial incentives allocated to an account each week during the intervention and financial incentives taken away each day the step goal was not achieved.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 9, 2020
Est. primary completion date June 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Veterans - Body mass index of 25 or greater - Access to smartphone or tablet to sync wearable device data - Interest in participating in a 20-week physical activity program Exclusion Criteria: - Already participating in a physical activity research study - Unable to provide informed consent - Unsafe or infeasible to participate - No access to smartphone or table to sync wearable device data

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Incentive Gamification
Game-based intervention with points and levels
Support Sponsor
Participants select a support sponsor to receive weekly updates on progress in the game
Financial Incentive
Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met

Locations

Country Name City State
United States Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Philadelphia Pennsylvania
United States Philadelphia MultiService Center, Philadelphia, PA Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mean Daily Steps From Baseline Relative to Control Daily steps counts Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
Secondary Change in Mean Daily Steps From Baseline Relative to Control Daily step counts Follow-up period of weeks 13 to 20
Secondary Proportion of Participant-days Step Counts Were Achieved Relative to Control Proportion of days for a participants that their step goal target was achieved Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
Secondary Proportion of Participant-days Step Counts Were Achieved Proportion of days for a participants that their step goal target was achieved Follow-up period of weeks 13 to 20
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