NCT06446076

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (estimated)
• Sponsor: St. Luke's International Hospital, Japan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-12
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-06-06
• Last updated: 2025-05-15

Locations

1 site across 1 country: Japan