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

NCT ID: NCT06446076

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2026-03-31

Brief Summary

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.

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.

Conditions

Cardiovascular Diseases; Rehabilitation; Behavioral Economics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Gamification (Loss framing)

This group will receive a gamification intervention with loss framing.

Group Type: EXPERIMENTAL

Gamification (Gain/Loss framing)

Intervention Type: BEHAVIORAL

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.

Gamification (Gain framing)

This group will receive a gamification intervention with gain framing.

Group Type: EXPERIMENTAL

Gamification (Gain/Loss framing)

Intervention Type: BEHAVIORAL

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.

Gamification (Loss framing) + Social support

This group will receive a gamification intervention with loss framing and a social support intervention.

Group Type: EXPERIMENTAL

Gamification (Gain/Loss framing)

Intervention Type: BEHAVIORAL

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.

Social support

Intervention Type: BEHAVIORAL

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.

Gamification (Gain framing) + Social support

This group will receive a gamification intervention with gain framing and a social support intervention.

Group Type: EXPERIMENTAL

Gamification (Gain/Loss framing)

Intervention Type: BEHAVIORAL

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.

Social support

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trigen

INDUSTRY

Sponsor Role: collaborator

St. Luke's International Hospital, Japan

OTHER

Sponsor Role: lead

Responsible Party

Atsushi Mizuno

Director, Medical quality management office

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atsushi Mizuno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Medicine, St. Luke's International Hospital

Locations

St. Luke's International Hospital

Tokyo, Tokyo, Japan

Countries

Japan

References

Suzuki T, Aoki J, Abe K, Asano T, Yoneoka D, Sato S, Rewley J, Miyata K, Ono M, Saito A, Kanie T, Okui K, Takahashi A, Isa K, Takasago S, Shiina Y, Nishihata Y, Niinuma H, Masuda K, Kijima Y, Nishida H, Komiyama N, Sugibuchi K, Suzuki Y, Igarashi A, Suzumura S, Tsurugi N, Okamura D, Mizuno A; FOOTSTEPS Investigators. Rationale and Trial Design of Feedbacks Using Behavioural Economic Theories on STEP Counts (FOOTSTEPS) Trial in Patients With Cardiovascular Disease. CJC Open. 2024 Dec 27;7(4):535-544. doi: 10.1016/j.cjco.2024.12.009. eCollection 2025 Apr.

Reference Type: DERIVED

PMID: 40433138 (View on PubMed)

Other Identifiers

23-RCK043

Identifier Type: -

Identifier Source: org_study_id