Clinical trial NCT06486532: HeartBeet Clinic Pilot Trial
Official title: HeartBeet Clinic Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Hypertension
Keywords: Cardiovascular health
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Within 2 weeks post-intervention
Secondary outcomes:
measure: Recruitment and Retention feasibility
timeFrame: End of study (5 months)
measure: Cardiovascular health
timeFrame: Within 2 weeks post-intervention
Other outcomes:
Locations:
city: Saint Louis Park
country: United States
facility: Park Nicollet Cardiology
state: Minnesota
Study officials:
References: