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Cardiovascular DiseasesFOOTSTEPSNCT06446076

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

A study testing Gamification (Gain/Loss framing) and Social support in people with Cardiovascular Diseases and Rehabilitation, run by St. Luke's International Hospital, Japan at 1 site in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gamification (Gain/Loss framing) and Social support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
1 siteJapan
Study dates
12 Jun 2024to 31 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • St. Luke's International Hospital

    Tokyo, Tokyo, 1048560

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
Gamification (Gain/Loss framing), Social support
Keywords
Cardiovascular diseases, Rehabilitation, Behavioral Economics, Health Services
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamification (Gain/Loss framing)Behavioural

    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 supportBehavioural

    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.

Study groups in NCT06446076
Study groupRoleWhat they receive
Control groupNo interventionParticipants 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)ExperimentalThis group will receive a gamification intervention with loss framing.
Receives: Behavioral: Gamification (Gain/Loss framing)
Gamification (Gain framing)ExperimentalThis group will receive a gamification intervention with gain framing.
Receives: Behavioral: Gamification (Gain/Loss framing)
Gamification (Loss framing) + Social supportExperimentalThis group will receive a gamification intervention with loss framing and a social support intervention.
Receives: Behavioral: Gamification (Gain/Loss framing); Behavioral: Social support
Gamification (Gain framing) + Social supportExperimentalThis group will receive a gamification intervention with gain framing and a social support intervention.
Receives: Behavioral: Gamification (Gain/Loss framing); Behavioral: Social support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start12 Jun 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
325 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446076
Sponsor's protocol ID
23-RCK043
Acronym
FOOTSTEPS
Status last verified
May 2025
First submitted
30 May 2024
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40433138

Questions about this trial

What is this clinical trial studying?

A study testing Gamification (Gain/Loss framing) and Social support in people with Cardiovascular Diseases and Rehabilitation, run by St. Luke's International Hospital, Japan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06446076, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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