NCT06486532Completed
HeartBeet Clinic Pilot Trial
HeartBeet Clinic Randomized Pilot Trial
Source: ClinicalTrials.gov · Last updated 11 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 24 Jun 2024
- Start date
- 6 Jan 2025
- Primary completion date
- 18 Apr 2025
- Lead sponsor
- HealthPartners Institute
- Diseases
- High blood pressure
- NCT number
- NCT06486532
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 6 Jan 2025 to the primary completion date, 18 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another treatment or intervention study
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Park Nicollet Cardiology Coordinator of this site? Confirm its status | Saint Louis Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.