An interventional study of HeartBeet Clinic and Self-paced education in Hyperlipidemia and Hypertension, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Prevention
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.
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.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's enrollment of 60 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
16 week group based lifestyle intervention
Behavioral: HeartBeet Clinic
Online learning of lifestyle medicine
Behavioral: Self-paced education
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 course and workbook with no contact with study clinician or health coach expert
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.
Time frame: Within 2 weeks post-intervention
Recruitment and Retention feasibility
Assess feasibility of the intervention based on meeting recruitment and retention targets.
Time frame: 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.
Time frame: Within 2 weeks post-intervention
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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