Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
HeartBeet Clinic Pilot Trial
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
HeartBeet Clinic Randomized Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of the current study is to conduct a pilot randomized controlled trial comparing the HeartBeet Clinic a 16-week lifestyle medicine program with virtual small-group coaching to a self-paced online education program In this pilot study the primary goals will be to assess acceptability and feasibility of the study and intervention procedures to prepare for a larger efficacy trial
Detailed Description:
Individuals randomized to the 16-week HeartBeet Clinic lifestyle medicine intervention will complete two in-person group visits one at the beginning and one at the end of the program They will also attend group coaching sessions that will be held virtually using an online coaching platform that will house the self-paced course intervention materials and schedule for the coaching and live events Individuals in this group will be asked to attend 12 group coaching sessions with a health coach 6 skills sessions to enhance behavior change skills with a health coach and 6 deep dives with subject matter experts These sessions will require 1-2 hours of participation per week In addition participants will be asked to work through the self-paced course and workbook activities on their own between sessions
Individuals randomized to the self-paced education group will have access to the virtual coaching platform for the self-paced course and workbook They will receive email reminders to work through the workbook activities They will not have contact with the study clinician or health coach except to troubleshoot technical issues
Individuals randomized to the self-paced education group will have access to the virtual coaching platform for the self-paced course and workbook They will receive email reminders to work through the workbook activities They will not have contact with the study clinician or health coach except to troubleshoot technical issues
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