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NCT Number: NCT06446076

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases Behavioral Economics Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke's International Hospital

Tokyo, 1048560, Japan

About this study

The three aims of this randomized controlled trials;

  • To demonstrate the effectiveness of loss framing in gamification for achieving increased physical activity in patients with CVD.
  • To demonstrate the effectiveness of social support in gamification for achieving increased physical activity in patients with CVD.
  • 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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in mean daily step counts

    Time frame: From enrollment to the end of intervention period at 8 weeks (2-weeks run-in and 6-weeks intervention period)

    The primary outcome is change in mean daily step counts from baseline to the 6-week intervention period.

Secondary outcomes

  1. Percentage of days achieving their step goals

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

    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.

Other outcomes

  1. Change in International Physical Activity Questionnaire (IPAQ)

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

    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.

  2. Change in Body weight (BMI)

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

    Change in body weight (BMI) (kg/m^2)

  3. Change in LDL/HDL cholesterol

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

    Change in LDL/HDL cholesterol (mg/dL)

Sponsors and collaborators

Lead sponsor

St. Luke's International Hospital, Japan

Other

Collaborators

  • Trigen

Registry information

Official study title

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

Acronym: FOOTSTEPS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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