HyperlipidemiaNCT06486532
HeartBeet Clinic Pilot Trial
A study testing HeartBeet Clinic and Self-paced education in people with Hyperlipidemia and Hypertension, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia, Hypertension
- What is being tested?
- HeartBeet Clinic and Self-paced education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Cardiology
Saint Louis Park, Minnesota, 55426
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperlipidemia, Hypertension
- Being tested
- HeartBeet Clinic, Self-paced education
- Keywords
- Cardiovascular health
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartBeet ClinicBehavioural
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.
Self-paced educationBehavioural
Self-paced course and workbook with no contact with study clinician or health coach expert
| Study group | Role | What they receive |
|---|---|---|
| HeartBeet Clinic | Experimental | 16 week group based lifestyle intervention Receives: Behavioral: HeartBeet Clinic |
| Self-paced education | Active comparator | Online learning of lifestyle medicine Receives: Behavioral: Self-paced education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 weeks post-intervention
Secondary outcomes (2)
Recruitment and Retention feasibility
Assess feasibility of the intervention based on meeting recruitment and retention targets.
Measured: 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.
Measured: Within 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start6 Jan 2025
- Primary completion18 Apr 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Hooker, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486532
- Sponsor's protocol ID
- A24-048
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartBeet Clinic Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT06486532
- Acronym / sponsor ID
- A24-048
- Conditions
- Hyperlipidemia, Hypertension
- Keywords
- Cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartBeet Clinic | Experimental | Behavioral: HeartBeet Clinic16 week group based lifestyle intervention |
| Self-paced education | Active comparator | Behavioral: Self-paced educationOnline learning of lifestyle medicine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartBeet Clinic16 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. | Behavioural | HeartBeet Clinic |
| Self-paced educationSelf-paced course and workbook with no contact with study clinician or health coach expert | Behavioural | Self-paced education |
Primary outcome
Acceptability
Time frame: Within 2 weeks post-intervention
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.
2 secondary outcomes
Recruitment and Retention feasibility
Time frame: End of study (5 months)
Cardiovascular health
Time frame: Within 2 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
Related trials for Hyperlipidemia
RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Hyperlipidemia, Hypercholesterolemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartBeet Clinic and Self-paced education in people with Hyperlipidemia and Hypertension, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Within 2 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.