Status:
COMPLETED
HeartBeet Clinic Pilot Trial
Lead Sponsor:
HealthPartners Institute
Conditions:
Hyperlipidemia
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06486532
Start Date
January 6 2025
End Date
May 2 2025
Last Update
May 11 2025
Active Locations (1)
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1
Park Nicollet Cardiology
Saint Louis Park, Minnesota, United States, 55426