Park Nicollet Cardiology
Saint Louis Park, Minnesota, 55426, United States
NCT Number: NCT06486532
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Saint Louis Park, Minnesota, 55426, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: End of study (5 months)
Assess feasibility of the intervention based on meeting recruitment and retention targets.
Time frame: Within 2 weeks post-intervention
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.
HealthPartners Institute
Other
HeartBeet Clinic Randomized Pilot Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01764178
Cardiovascular Diseases, Dyslipidemias
Seoul, South Korea
View Trial DetailsNCT04977583
Cardiovascular Disease, Cardiovascular Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT06543706
Body Weight, Brain Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT02029989
Bipolar Disorder, Bipolar and Related Disorders
Duluth, Minnesota, United States
View Trial Details