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

NCT06446076 | Active Not Recruiting

• 1 other identifier: 23-RCK043
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Rehabilitation; Behavioral Economics

Keywords

Cardiovascular diseases; Rehabilitation; Behavioral Economics; Health Services

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of days achieving their step goals

  From enrollment to the end of follow-up period at 14 weeks

Other Outcomes (3)

• Change in International Physical Activity Questionnaire (IPAQ)

  From enrollment to the end of follow-up period at 14 weeks

• Change in Body weight (BMI)

  From enrollment to the end of follow-up period at 14 weeks

• Change in LDL/HDL cholesterol

  From enrollment to the end of follow-up period at 14 weeks

Study Arms (5)

Control group

NO INTERVENTION

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.

Gamification (Loss framing)

EXPERIMENTAL

This group will receive a gamification intervention with loss framing.

Behavioral: Gamification (Gain/Loss framing)

Gamification (Gain framing)

EXPERIMENTAL

This group will receive a gamification intervention with gain framing.

Behavioral: Gamification (Gain/Loss framing)

Gamification (Loss framing) + Social support

EXPERIMENTAL

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

Behavioral: Gamification (Gain/Loss framing); Behavioral: Social support

Gamification (Gain framing) + Social support

EXPERIMENTAL

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

Behavioral: Gamification (Gain/Loss framing); Behavioral: Social support

Interventions

Gamification (Gain/Loss framing) 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); Gamification (Gain framing) + Social support; Gamification (Loss framing); Gamification (Loss framing) + Social support

Social support 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; Gamification (Loss framing) + Social support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's International Hospital, Japan: lead
• Trigen: collaborator

Study Sites (1)

St. Luke's International Hospital

Tokyo, Tokyo, 1048560, Japan

Location

Related Publications (1)

• 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.

  PMID: 40433138 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Atsushi Mizuno, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Medical quality management office

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 6, 2024
• Study Start: June 12, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)