Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients (FOOTSTEPS)

Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients: A Randomized Controlled Trial

This is a prospective, randomized controlled trial. The aim of the study is to verify the effectiveness of interventions using gamification with social incentives and social support to increase physical activity in patients with CVD through randomized controlled trials.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Rehabilitation; Behavioral Economics
• Intervention / Treatment: Behavioral: Gamification (Gain/Loss framing); Behavioral: Social support

Detailed Description

The three aims of this randomized controlled trials;

1. To demonstrate the effectiveness of loss framing in gamification for achieving increased physical activity in patients with CVD.
2. To demonstrate the effectiveness of social support in gamification for achieving increased physical activity in patients with CVD.
3. To evaluate the impact of the intervention using social incentives and social support through gamification on changes in participants; subjective assessment of physical activity levels, body mass index (BMI), and lipid panel in blood tests.

Secondary Objective:

1. To assess whether the differences between study groups in achieving the goal of increased physical activity during the 6-week intervention period persist during the 6-week follow-up period.
2. To investigate how the increase in physical activity through gamification in patients with CVD is influenced by patients; behavioral characteristics and environmental factors.

This trial will be a five-group, randomized controlled trial (RCT) with an intervention period of 6 weeks and a follow-up period of additional 6 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 1048560
    • St. Luke's International Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• History of old myocardial infarction or chronic heart failure
• Ability to read and provide informed consent to participate in this trial
• Owning a smartphone capable of installing this application

Exclusion Criteria:

• Having difficulty using smartphones (due to vision problems or IT literacy issues)
• Exercise therapy is contraindicated (in accordance with the 2021 revised guidelines on rehabilitation in cardiovascular diseases)
• Ability to read and provide informed consent to participate in this trial
• Owning a smartphone capable of installing this application
• Participating in other studies related to physical activity
• Being pregnant
• Any other medical conditions or reasons they are unable to participate in a physical activity study for 12 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants in this group will not receive goal-setting or gamification interventions during the 6-week intervention period and the additional 6-week follow-up period. As an "active control" during the 12-week trial period, participants will be able to check their daily step counts using an application with the same specifications.
Experimental: Gamification (Loss framing); This group will receive a gamification intervention with loss framing.	Behavioral: Gamification (Gain/Loss framing); Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, "Fresh Start" and "Loss Aversion". All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold.
Experimental: Gamification (Gain framing); This group will receive a gamification intervention with gain framing.	Behavioral: Gamification (Gain/Loss framing); Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, "Fresh Start" and "Loss Aversion". All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold.
Experimental: Gamification (Loss framing) + Social support; This group will receive a gamification intervention with loss framing and a social support intervention.	Behavioral: Gamification (Gain/Loss framing); Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, "Fresh Start" and "Loss Aversion". All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold.; Behavioral: Social support; Participants in this group are asked to designate a family member or friend to provide social support. This supporter is encouraged to check the participant's progress and provide support during the interventional period. The supporter will also receive weekly emails throughout the period, informing them about the participant's daily step counts, achievement status, points, levels, and other relevant information.
Experimental: Gamification (Gain framing) + Social support; This group will receive a gamification intervention with gain framing and a social support intervention.	Behavioral: Gamification (Gain/Loss framing); Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, "Fresh Start" and "Loss Aversion". All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold.; Behavioral: Social support; Participants in this group are asked to designate a family member or friend to provide social support. This supporter is encouraged to check the participant's progress and provide support during the interventional period. The supporter will also receive weekly emails throughout the period, informing them about the participant's daily step counts, achievement status, points, levels, and other relevant information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean daily step counts	The primary outcome is change in mean daily step counts from baseline to the 6-week intervention period.	From enrollment to the end of intervention period at 8 weeks (2-weeks run-in and 6-weeks intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of days achieving their step goals	Secondary outcomes include the percentage of days achieving their step goals during the intervention and follow-up periods and the change in daily step counts from baseline to follow-up period.	From enrollment to the end of follow-up period at 14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Physical Activity Questionnaire (IPAQ)	Change in the participant's subjective assessment of physical activity level measured using the International Physical Activity Questionnaire (IPAQ) Short Form. This is a survey that investigates how individuals engage in physical activity (how they move their bodies) in their daily lives. It is a questionnaire that assesses the duration and frequency of exercise based on intensity levels.	From enrollment to the end of follow-up period at 14 weeks
Change in Body weight (BMI)	Change in body weight (BMI) (kg/m^2)	From enrollment to the end of follow-up period at 14 weeks
Change in LDL/HDL cholesterol	Change in LDL/HDL cholesterol (mg/dL)	From enrollment to the end of follow-up period at 14 weeks

Collaborators and Investigators

• Sponsor: St. Luke's International Hospital, Japan
• Collaborators: Trigen
• Investigators: Principal Investigator: Atsushi Mizuno, MD, PhD, Department of Cardiovascular Medicine, St. Luke's International Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Cardiovascular diseases; Behavioral Economics; Health Services
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 23-RCK043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No