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Clinical Trials/NCT05259150
NCT05259150
Enrolling By Invitation
Not Applicable

The Health for Hearts United Collaborative

Florida State University1 site in 1 country225 target enrollmentJanuary 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease Risk Reduction
Sponsor
Florida State University
Enrollment
225
Locations
1
Primary Endpoint
Participant Reach
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
January 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Penny Ralston

Professor, Dean Emeritus & Director, Center on Better Health

Florida State University

Eligibility Criteria

Inclusion Criteria

  • African American,
  • 18 years of age and older,
  • not pregnant in the last six months,
  • not hospitalized or having a clinically significant medical condition in the past six months

Exclusion Criteria

  • not being African American,
  • under the age of 18,
  • pregnant in the last six months,
  • hospitalized or having a clinically significant medical condition in the past six months.

Outcomes

Primary Outcomes

Participant Reach

Time Frame: 12 months

Percent of participants that are retained in the intervention which will be computed by dividing the number of participants who complete the intervention by the number who enrolled.

Intervention Adoption

Time Frame: 12 months

Number of participants who attend intervention sessions which is computed by adding the number of attendees to create total attendance.

Intervention Implementation

Time Frame: 12 months

Checklist to be developed by the investigators and completed by staff that monitors church health leaders' planning for health ministry development and delivery of program to participants.

Intervention Maintenance

Time Frame: 12 months

Checklist to be developed by investigators regarding whether or not annual plans are submitted. The instrument will include the list of churches and columns for checking yes or no.

Secondary Outcomes

  • Height(12 months)
  • Fruit and vegetable intake(12 months)
  • Fat intake(12 months)
  • Blood pressure(12 months)
  • Weight(12 months)
  • Food choice(12 months)
  • Objective physical activity(12 months)
  • Abdomen circumference(12 months)
  • Self-report Physical activity(12 months)
  • Hip circumference(12 months)
  • Waist circumference(12 months)

Study Sites (1)

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