NCT05259150

The Health for Hearts United Collaborative

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in relation to process outcomes and reducing cardiovascular disease (CVD) risk in African Americans (AAs),examining two possible strategies.

Detailed description

This project will determine the effectiveness of HHUC implementation strategies in relation to process outcomes and reducing CVD risk in AAs, guided by ecological theory, the Consolidated Framework for Implementation Research (CFIR), and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. The HHUC model currently includes three components: governance structure, annual events, and basic support. The investigators propose adding a fourth component that includes one of two possible implementation strategies: 1) an internal champions (IC)-driven strategy that includes two features (leadership development, culturally-tailored planning approaches) or 2) an external change agent (external professionals \[EP\])-driven strategy without these features. The investigators will pilot and refine the IC and EP-driven implementation strategies using health leaders from four churches in the two-county area by determining feasibility and acceptability. Following the pilot, the investigators will use an effectiveness implementation hybrid Type 3 design to evaluate the IC and EP implementation strategies in relation to process outcomes. The study will be conducted in a two-county area in North Florida, using congregants ((18 years of age and older, n=225) in nine churches: three IC treatment, three EP treatment, and three comparison with delayed comparable activities.

Conditions

• Cardiovascular Disease Risk Reduction

Interventions

Type	Name	Description
BEHAVIORAL	Health for Hearts United Planning for Health	Participants (health leaders) receive trainings (three entitled Take Charge of Your Health, Eat Better, \& Move Around More) and plan for their health ministry and cardiovascular health program to congregants.
BEHAVIORAL	Health for Hearts United Preparing for Health	Research participants (church congregants) receive cardiovascular health programming prepared by health leaders that includes the following best practices: Individual Goal Setting, Training, Culturally-tailored Materials, Monitoring Tool \& Recognition.
BEHAVIORAL	Health for Hearts United Delivery of Health	The Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices).
OTHER	Health for Hearts United Comparison Group Health Ministry Development	Participants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program.

Timeline

• Start date: 2022-01-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-02-28
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States