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Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease (BE ACTIVE)

Primary Purpose

Atherosclerotic Cardiovascular Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gamification
Financial
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atherosclerotic Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Have a 10-year ASCVD risk score of 7.5% or greater (including those with existing ASCVD)
  • Are able to provide informed consent

Exclusion Criteria:

  • Are already participating in another physical activity study
  • An 18-month physical activity program is infeasible (e.g. metastatic cancer; unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise)
  • They do not have a device (e.g. smartphone, tablet, or computer) to transmit data from the wearable activity tracker
  • Baseline step count is 7,500 or greater
  • They do not have a primary care physician in the University of Pennsylvania Health System.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Gamification Intervention

Financial Incentive Intervention

Gamification and Financial Incentive Intervention

Arm Description

Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.

Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level. In the follow-up period, participants continue to get a daily text stating if they met their step goal.

Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets. During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.

Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.

Outcomes

Primary Outcome Measures

Change in mean daily step counts during the 12 month intervention using a wearable pedometer (Fitbit watch) to measure step count.
Change in mean daily steps counts from baseline to the 12-month intervention period, excluding the 8-week ramp-up phase. This will be measured using the Fitbit Charge 3 wearable device.

Secondary Outcome Measures

Change in mean daily step counts during the 6 month follow-up using a wearable pedometer (Fitbit watch) to measure step count.
Change in mean daily steps from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge 3 wearable device.
Change in mean daily minutes of moderate to vigorous physical activity (MVPA) during the 12 month intervention using a wearable device (Fitbit watch) to measure MVPA derived from step counts.
Change in mean daily minutes of MVPA from baseline to the intervention period, excluding the 8-week ramp up phase. This will be measured using the Fitbit Charge 3 wearable device.
Change in mean daily minutes of moderate to vigorous physical activity (MVPA) during the 6 month follow-up using a wearable device (Fitbit watch) to measure MVPA derived from step counts.
Change in mean daily minutes of MVPA from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge 3 wearable device.

Full Information

First Posted
April 3, 2019
Last Updated
September 14, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03911141
Brief Title
Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
Acronym
BE ACTIVE
Official Title
Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
July 24, 2023 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to use a randomized, controlled trial to test the effectiveness of using gamification, financial incentives, or both to increase physical activity among patients with elevated risk for atherosclerotic cardiovascular disease (ASCVD). ASCVD is the leading cause of morbidity and mortality in the United States. Regular physical activity has been shown to reduce the risk of ASCVD, but less than 50% of US adults achieve enough physical activity to obtain these benefits.
Detailed Description
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality in the United States (US). Regular physical activity has been demonstrated to reduce the risk of ASCVD and is associated with a number of other health benefits. Yet, less than 50% of adults in the US achieve enough physical activity to actually obtain these benefits. Insights from behavioral economics have been shown to both better reflect the 'predictable irrationality' of humans and to be effective in designing interventions that achieve sustained improvements in health behavior. Our prior work has demonstrated that interventions using financial incentives and gamification can leverage principles from behavioral economics to increase physical activity during 3-month interventions and sustain effects in 3-month follow-up periods. These findings warrant further investigation of longer-term effects. In this study, we conduct a four-arm randomized, controlled trial to evaluate the effectiveness of using behavioral economic approaches including gamification, financial incentives, or both to increase physical activity among patients with elevated risk for atherosclerotic cardiovascular disease during a 12-month intervention with a 6-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive a daily text message stating whether or not they achieved their step goal on the prior day during the 12 months of intervention and 6 months of follow-up.
Arm Title
Gamification Intervention
Arm Type
Experimental
Arm Description
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level. In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Arm Title
Financial Incentive Intervention
Arm Type
Experimental
Arm Description
Participants are informed that each week that money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets. During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Arm Title
Gamification and Financial Incentive Intervention
Arm Type
Experimental
Arm Description
Participants receive both of the interventions described in the Gamification Intervention arm and the Financial Incentive Intervention arm.
Intervention Type
Behavioral
Intervention Name(s)
Gamification
Intervention Description
Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals. Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels. Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level. In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Intervention Type
Behavioral
Intervention Name(s)
Financial
Intervention Description
Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets. During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day.
Primary Outcome Measure Information:
Title
Change in mean daily step counts during the 12 month intervention using a wearable pedometer (Fitbit watch) to measure step count.
Description
Change in mean daily steps counts from baseline to the 12-month intervention period, excluding the 8-week ramp-up phase. This will be measured using the Fitbit Charge 3 wearable device.
Time Frame
Months 1-12
Secondary Outcome Measure Information:
Title
Change in mean daily step counts during the 6 month follow-up using a wearable pedometer (Fitbit watch) to measure step count.
Description
Change in mean daily steps from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge 3 wearable device.
Time Frame
Months 1-18
Title
Change in mean daily minutes of moderate to vigorous physical activity (MVPA) during the 12 month intervention using a wearable device (Fitbit watch) to measure MVPA derived from step counts.
Description
Change in mean daily minutes of MVPA from baseline to the intervention period, excluding the 8-week ramp up phase. This will be measured using the Fitbit Charge 3 wearable device.
Time Frame
Months 1-12
Title
Change in mean daily minutes of moderate to vigorous physical activity (MVPA) during the 6 month follow-up using a wearable device (Fitbit watch) to measure MVPA derived from step counts.
Description
Change in mean daily minutes of MVPA from baseline to the post-intervention follow-up period. This will be measured using the Fitbit Charge 3 wearable device.
Time Frame
Months 1-18
Other Pre-specified Outcome Measures:
Title
Proportion of weeks that achieve 150 minutes of MVPA during the 12 month intervention using a wearable device (Fitbit watch) to measure MVPA derived from step counts.
Description
Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the the intervention period. This will be measured using the Fitbit Charge 3 wearable device.
Time Frame
Months 1-12
Title
Proportion of weeks that achieve 150 minutes of MVPA during the 6 month follow-up using a wearable device (Fitbit watch) to measure MVPA derived from step counts.
Description
Proportion of weeks that achieve at least 150 minutes of MVPA per week from baseline to the follow-up period. This will be measured using the Fitbit Charge 3 wearable device.
Time Frame
Months 1-18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Have a 10-year ASCVD risk score of 7.5% or greater (including those with existing ASCVD) Are able to provide informed consent Exclusion Criteria: Are already participating in another physical activity study An 18-month physical activity program is infeasible (e.g. metastatic cancer; unable to ambulate or provide informed consent) or unsafe (currently pregnant or told by a physician not to exercise) They do not have a device (e.g. smartphone, tablet, or computer) to transmit data from the wearable activity tracker Baseline step count is 7,500 or greater They do not have a primary care physician in the University of Pennsylvania Health System.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh Patel, MD, MBA, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Fanaroff, MD, MHS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease

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