Physical ActivityNCT03563027

Social and Financial Incentives to Increase Physical Activity Among Overweight and Obese Veterans

A study testing Social Incentive Gamification, Support Sponsor and Financial Incentive in people with Physical Activity, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Physical Activity
What is being tested?: Social Incentive Gamification, Support Sponsor and Financial Incentive
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 2 sitesUnited States
Study dates: 19 Mar 2019to 9 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19106

Other trials in United States

About this study

Official title: Evaluating Connected Health Approaches to Improving the Health of Veterans (CDA 15-065)

Read the 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.

Conditions: Physical Activity
Being tested: Social Incentive Gamification, Support Sponsor, Financial Incentive
Keywords: Physical activity, Incentive, Wearable device, Gamification
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03563027
Study group	Role	What they receive
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 Receives: Behavioral: Social Incentive Gamification; Behavioral: 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 Receives: Behavioral: Social Incentive Gamification; Behavioral: Support Sponsor; Behavioral: Financial Incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 20199 Aug 2020

First posted20 Jun 2018
Study start19 Mar 2019
Primary completion14 Jun 2020
Study completion9 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical ActivityStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel 3-arm randomized, controlled trial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03563027
Sponsor's protocol ID: CDX 18-003
Other IDs: HX-001922-01
Status last verified: Aug 2021
First submitted: 6 Jun 2018
Last updated: 28 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34241628

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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Enrolling by invitation
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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating Connected Health Approaches to Improving the Health of Veterans (CDA 15-065)
ClinicalTrials.gov ID: NCT03563027
Acronym / sponsor ID: CDX 18-003
Conditions: Physical Activity
Keywords: Physical activity, Incentive, Wearable device, Gamification
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 19 Mar 2019 (actual)
Primary completion: 14 Jun 2020 (actual)
Study completion: 9 Aug 2020 (actual)
First posted: 20 Jun 2018 (actual)
Results: Posted 28 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: Parallel 3-arm randomized, controlled trial

Arm	Type	Receives
Control	No intervention	–This arm serves as control and uses a wearable device to track daily step counts
Social Incentive Gamification	Experimental	Behavioral: Social Incentive Gamification, Behavioral: Support SponsorThis arm uses a wearable device to track daily step counts, is entered into social incentive gamification, and selects a support sponsor
Social Incentive Gamification and Financial Incentive	Experimental	Behavioral: Social Incentive Gamification, Behavioral: Support Sponsor, Behavioral: Financial IncentiveThis 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Social Incentive GamificationGame-based intervention with points and levels	Behavioural	Social Incentive Gamification, Social Incentive Gamification and Financial Incentive
Support SponsorParticipants select a support sponsor to receive weekly updates on progress in the game	Behavioural	Social Incentive Gamification, Social Incentive Gamification and Financial Incentive
Financial IncentiveParticipants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met	Behavioural	Social Incentive Gamification and Financial Incentive

Primary outcome

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

3 secondary outcomes

Change in Mean Daily Steps From Baseline Relative to Control
Time frame: 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 Participant-days Step Counts Were Achieved
Time frame: Follow-up period of weeks 13 to 20

Results and safety

Results posted to the registry on 28 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	60	60
Social Incentive Gamification	60	60
Social Incentive Gamification and Financial Incentive	60	58

Primary outcome: 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. Mean (Standard Deviation). Unit: Mean daily steps

Measure	Control n = 60	Social Incentive Gamification n = 60	Social Incentive Gamification and Financial Incentive n = 58
Value	6195 (3767)	6709 (3827)	7599 (3897)

Control vs Social Incentive Gamification: Mean Difference (Net): 433 (95% CI -337 to 1203), p = .81, Regression, Linear
Control vs Social Incentive Gamification and Financial Incentive: Mean Difference (Net): 1224 (95% CI 451 to 1996), p = .005, Regression, Linear

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 22 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Social Incentive Gamification	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Social Incentive Gamification and Financial Incentive	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34241628Agarwal 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.
Individual participant dataSharing planned: No

Related trials for Physical Activity

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mitesh S. Patel, MD MBA MS principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Social Incentive Gamification, Support Sponsor and Financial Incentive in people with Physical Activity, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.