HeartBeet Clinic Pilot Trial

NCT06486532 | Completed

• 1 other identifier: A24-048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia; Hypertension

Keywords

Cardiovascular health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recruitment and Retention feasibility

  End of study (5 months)

• Cardiovascular health

  Within 2 weeks post-intervention

Study Arms (2)

HeartBeet Clinic

EXPERIMENTAL

16 week group based lifestyle intervention

Behavioral: HeartBeet Clinic

Self-paced education

ACTIVE COMPARATOR

Online learning of lifestyle medicine

Behavioral: Self-paced education

Interventions

HeartBeet Clinic BEHAVIORAL

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.

HeartBeet Clinic

Self-paced education BEHAVIORAL

Self-paced course and workbook with no contact with study clinician or health coach expert

Self-paced education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Park Nicollet Cardiology

Saint Louis Park, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypertension

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: January 6, 2025
• Primary Completion: April 18, 2025
• Study Completion: May 2, 2025
• Last Updated: May 11, 2025

Record last verified: 2024-06

Locations

US (1)