NCT03563027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

March 19, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 28, 2021

Completed
Last Updated

September 28, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

June 6, 2018

Results QC Date

May 24, 2021

Last Update Submit

August 31, 2021

Conditions

Keywords

Physical activityIncentiveWearable deviceGamification

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Mean Daily Steps From Baseline Relative to Control

    Follow-up period of weeks 13 to 20

  • Proportion of Participant-days Step Counts Were Achieved Relative to Control

    Intervention period of weeks 5 to 12 which excludes the 4-week ramp-up

  • Proportion of Participant-days Step Counts Were Achieved

    Follow-up period of weeks 13 to 20

Study Arms (3)

Control

NO INTERVENTION

This arm serves as control and uses a wearable device to track daily step counts

Social Incentive Gamification

EXPERIMENTAL

This arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor

Behavioral: Social Incentive GamificationBehavioral: Support Sponsor

Social Incentive Gamification and Financial Incentive

EXPERIMENTAL

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

Behavioral: Social Incentive GamificationBehavioral: Support SponsorBehavioral: Financial Incentive

Interventions

Game-based intervention with points and levels

Social Incentive GamificationSocial Incentive Gamification and Financial Incentive
Support SponsorBEHAVIORAL

Participants select a support sponsor to receive weekly updates on progress in the game

Social Incentive GamificationSocial Incentive Gamification and 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

Social Incentive Gamification and Financial Incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia MultiService Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

First, participants were from a single VA system and needed access to a smartphone or tablet, which may limit generalizability. Second, among the 10,000 Veterans invited by mail, only about 7% expressed interest and only about 2% were ultimately enrolled. These participants had higher than step counts at baseline and may not be representative of the target population for this type of intervention. Third, we evaluated activity using step counts, did not have data on other measures of activity.

Results Point of Contact

Title
Dr. Mitesh S. Patel
Organization
Crescenz Veterans Affairs Medical Center

Study Officials

  • Mitesh S. Patel, MD MBA MS

    Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and Outcomes assessor will be masked until the trial is completed and all analyses are finished.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel 3-arm randomized, controlled trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 20, 2018

Study Start

March 19, 2019

Primary Completion

June 14, 2020

Study Completion

August 9, 2020

Last Updated

September 28, 2021

Results First Posted

September 28, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations