Clinical trial NCT03563027: Social and Financial Incentives to Increase Physical Activity Among Overweight and Obese Veterans
Official title: Evaluating Connected Health Approaches to Improving the Health of Veterans (CDA 15-065)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical activity
Incentive
Wearable device
Gamification
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-06-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel 3-arm randomized, controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Daily Steps From Baseline Relative to Control
timeFrame: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
Secondary outcomes:
measure: Change in Mean Daily Steps From Baseline Relative to Control
timeFrame: Follow-up period of weeks 13 to 20
measure: Proportion of Participant-days Step Counts Were Achieved Relative to Control
timeFrame: Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up
measure: Proportion of Participant-days Step Counts Were Achieved
timeFrame: Follow-up period of weeks 13 to 20
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia MultiService Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Mitesh S. Patel, MD MBA MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal AK, Waddell KJ, Small DS, Evans C, Harrington TO, Djaraher R, Oon AL, Patel MS. Effect of Gamification With and Without Financial Incentives to Increase Physical Activity Among Veterans Classified as Having Obesity or Overweight: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116256. doi: 10.1001/jamanetworkopen.2021.16256.