Social and Financial Incentives to Increase Physical Activity Among Overweight and Obese Veterans
August 31, 2021 updated by: VA Office of Research and Development
Evaluating Connected Health Approaches to Improving the Health of Veterans (CDA 15-065)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
180
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
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
-
Philadelphia, Pennsylvania, United States, 19106
- Philadelphia MultiService Center, Philadelphia, PA
-
-
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:
- 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 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
This arm serves as control and uses a wearable device to track daily step counts
|
|
|
Experimental: Social Incentive Gamification
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
|
Game-based intervention with points and levels
Participants select a support sponsor to receive weekly updates on progress in the game
|
|
Experimental: Social Incentive Gamification and Financial Incentive
This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, selects a support sponsor, and receives a financial incentive
|
Game-based intervention with points and levels
Participants select a support sponsor to receive weekly updates on progress in the game
Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Daily Steps From Baseline Relative to Control
Time Frame: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
|
Daily steps counts
|
Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Daily Steps From Baseline Relative to Control
Time Frame: Follow-up period of weeks 13 to 20
|
Daily step counts
|
Follow-up period of weeks 13 to 20
|
|
Proportion of Participant-days Step Counts Were Achieved Relative to Control
Time Frame: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
|
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
|
|
Proportion of Participant-days Step Counts Were Achieved
Time Frame: Follow-up period of weeks 13 to 20
|
Proportion of days for a participants that their step goal target was achieved
|
Follow-up period of weeks 13 to 20
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mitesh S. Patel, MD MBA MS, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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.
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)
March 19, 2019
Primary Completion (Actual)
June 14, 2020
Study Completion (Actual)
August 9, 2020
Study Registration Dates
First Submitted
June 6, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
August 31, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CDX 18-003
- HX-001922-01 (Other Grant/Funding Number: Cpl Michael J. Crescenz VA Medical Center)
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
product manufactured in and exported from the U.S.
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.