HeartBeet Clinic Pilot Trial

HeartBeet Clinic Randomized Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hyperlipidemia
• Intervention / Treatment: Behavioral: HeartBeet Clinic; Behavioral: Self-paced education

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have at least one cardiovascular risk factor, including: a) high cholesterol, as defined as diagnosis of hyperlipidemia and/or most recent total cholesterol > 200 or b) hypertension (as defined by a diagnosis of hypertension and/or active antihypertensive medication prescription) and/or BMI > 27
• Identify as a HealthPartners patient, including having an outpatient encounter with a HealthPartners or Park Nicollet clinician in the prior year
• Be willing to pay for copays/charges for group medical visit and labs drawn as part of usual care if not fully covered by insurance
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Willingness to maintain current doses of statin, anti-obesity medication, and/or antihypertensive medication during the study
• Willingness and ability to attend weekly group coaching sessions for 16 weeks at ≥ 1 scheduled group coaching time
• Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access

Exclusion Criteria:

• Concurrent participation in another treatment or intervention study
• History of coronary artery, cerebrovascular or peripheral arterial disease including myocardial infarction, unstable angina, revascularization, stroke/TIA, carotid intervention, claudication, or congestive heart failure
• Existing diagnosis of dementia and/or other cognitive impairment that would be a barrier to participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HeartBeet Clinic; 16 week group based lifestyle intervention	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.
Active Comparator: Self-paced education; Online learning of lifestyle medicine	Behavioral: Self-paced education; Self-paced course and workbook with no contact with study clinician or health coach expert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Assess the acceptability using Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). Participants report the extent to which the intervention met their expectations on a 8-item scale. Participants rate the quality of the service and their satisfaction with the services provided on a 4-point Likert-type scale with varying response options (e.g., "How would you rate the quality of the service you received? 4 = Excellent, 3 = Good, 2 = Fair, or 1 = Poor). Items were summed for a total score ranging from 8 to 32, with higher scores corresponding to greater satisfaction with treatment.	Within 2 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and Retention feasibility	Assess feasibility of the intervention based on meeting recruitment and retention targets.	End of study (5 months)
Cardiovascular health	Cardiovascular health will be measured by Life's Essential 8 (Lloyd-Jones et al., 2022), a composite measure that includes 8 domains: diet quality, physical activity, smoking, sleep, lipids, blood pressure, blood glucose, and body mass index. Each domain is scored on a scale from 0-100; a total cardiovascular health score is the average of the 8 domains.	Within 2 weeks post-intervention

Collaborators and Investigators

• Sponsor: HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): April 18, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular health
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias
• Other Study ID Numbers: A24-048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No