Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446076
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-07
First Post:
2024-05-30
Brief Title:
Feedback Using BehaviOral EconOmic Theories on STEP CountS in Cardiovascular Disease Patients
Sponsor:
St Lukes International Hospital Japan
Organization:
St Lukes International Hospital Japan
Study Overview
Official Title:
Feedback Using BehaviOral EconOmic Theories on STEP CountS in Cardiovascular Disease Patients a Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOOTSTEPS
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None