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HeartBeet Clinic Pilot Trial

NCT06486532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

HeartBeet Clinic

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.

BEHAVIORAL

Self-paced education

Self-paced course and workbook with no contact with study clinician or health coach expert

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2025-04-18
Completion
2025-05-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486532 on ClinicalTrials.gov