NCT05554601

Brief Summary

Despite the many associated health benefits, more than half of Veterans do not achieve enough regular physical activity. The investigators' prior work has demonstrated that gamification, a method commonly used for health promotion, can lead to sustained increases in physical activity if it is designed using insights from behavioral economics to enhance social incentives. In this study, the investigators will compare the effectiveness of behaviorally designed gamification that encourages Veterans to collaborate or compete on physical activity levels and examine clinical outcomes as well as costs, barriers and facilitators to implementation of the program within Veterans Affairs.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
725

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
1mo left

Started Jul 2023

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress96%
Jul 2023Jul 2026

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

September 21, 2022

Last Update Submit

March 24, 2026

Conditions

Keywords

physical activity

Outcome Measures

Primary Outcomes (1)

  • change in physical activity

    change in mean steps per day from baseline to end of intervention

    6 months

Secondary Outcomes (2)

  • blood pressure

    6 months

  • weight

    6 months

Study Arms (3)

attention control

NO INTERVENTION

participants receive a FitBit and set goals but do no other intervention

gamification with collaboration

EXPERIMENTAL

participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on collaboration with each other

Behavioral: gamification with collaboration

gamification with competition

EXPERIMENTAL

participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on competition with each other

Behavioral: gamification with competition

Interventions

participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on collaboration

gamification with collaboration

participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on competition with each other

gamification with competition

Eligibility Criteria

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

You may qualify if:

  • Veterans receiving care at the CMCVAMC age 18 or older with a body mass index \> 30
  • a hypertension diagnosis with systolic blood pressure \>140mm Hg
  • are interested in participating in a 9-month physical activity program

You may not qualify if:

  • currently participating in another physical activity research study
  • any medical conditions prohibiting ambulation without assistance
  • if a 9-month physical activity program is infeasible or unsafe
  • if the Veteran is at a higher level of physical activity (i.e., baseline step count \>7500 steps per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

Related Publications (3)

  • Waddell KJ, Patel MS, Clark K, Harrington TO, Greysen SR. Effect of Gamification With Social Incentives on Daily Steps After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2022 May 1;79(5):528-530. doi: 10.1001/jamaneurol.2022.0231.

    PMID: 35344027BACKGROUND
  • Greysen SR, Waddell KJ, Patel MS. Exploring Wearables to Focus on the "Sweet Spot" of Physical Activity and Sleep After Hospitalization: Secondary Analysis. JMIR Mhealth Uhealth. 2022 Apr 27;10(4):e30089. doi: 10.2196/30089.

    PMID: 35476034BACKGROUND
  • Largent EA, Eriksen W, Barg FK, Greysen SR, Halpern SD. Participants' Perspectives on Payment for Research Participation: A Qualitative Study. Ethics Hum Res. 2022 Nov;44(6):14-22. doi: 10.1002/eahr.500147.

    PMID: 36316972BACKGROUND

MeSH Terms

Conditions

HypertensionObesityMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Scott R Greysen, MD

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

    PRINCIPAL INVESTIGATOR
  • Amol S. Navathe, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: behavioral economics approach (gamification with social incentives)
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

July 17, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations