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

Cardiovascular Diseases Clinical Trial

— FOOTSTEPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446076
• Other study ID #: 23-RCK043
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 12, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: June 2024
• Source: St. Luke's International Hospital, Japan
• Contact: Takahiro Suzuki, MD, MPH
• Phone: 810335415151
• Email: tasuzuki[@]luke.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Economics
• Cardiovascular Diseases
• Rehabilitation

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's International Hospital, Japan	Trigen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in LDL/HDL cholesterol	Change in LDL/HDL cholesterol (mg/dL)	From enrollment to the end of follow-up period at 14 weeks
Primary	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	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