NCT06486532

HeartBeet Clinic Pilot Trial

HeartBeet Clinic Randomized Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	HeartBeet Clinic	16 weeks of group based lifestyle medicine coaching covering the six pillars of lifestyle medicine. The six pillars of lifestyle medicine include regular physical activity; a whole-food plant-based diet; restorative sleep; limiting substance use (e.g., tobacco and alcohol use); having meaningful social connections; and stress management. Groups will be led by clinician or health coach expert.
BEHAVIORAL	Self-paced education	Self-paced course and workbook with no contact with study clinician or health coach expert

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-04-18
• Completion: 2025-05-02
• First posted: 2024-07-03
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States