The Health for Hearts United Collaborative (HHUC)

January 23, 2024 updated by: Penny Ralston, Florida State University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Penny A. Ralston, Ph.D.
  • Phone Number: (850) 841-0407
  • Email: pralston@fsu.edu

Study Contact Backup

  • Name: Marian Sumner, MPH
  • Phone Number: (850) 644-5468
  • Email: msumner@fsu.edu

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Center on Better Health and Life for Underserved Populations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internal Champion (IC) Strategy
In the Planning for Health intervention, the IC implementation strategy will include trainings on transformational leadership principles that address challenges that health leaders face in the church setting to assist them in independently planning the cardiovascular health programming for congregants. Limited assistance from staff will be provided in the Preparing for Health and the Delivery of Health interventions.
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).
Experimental: Expert Professional (EP) Strategy
In the Planning for Health intervention, the EP implementation strategy will include the use of external professionals to assist health leaders in the planning of cardiovascular health programming for congregants. Staff will assist health leaders in the Preparing for Health and the Delivery of Health interventions.
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).
Active Comparator: Comparison Group Strategy
In the Planning for Health intervention, the Comparison Group strategy will include process activities with the health leaders (identification of health leaders, meetings of health leaders, assistance of health leaders with recruitment of congregants for research). Except for data collection, participants (health leaders and congregants) will not be involved in the Preparing for Health or the Delivery of Health interventions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food choice
Time Frame: 12 months
Food choice questionnaire which is an 18 item list of foods frequently consumed by African Americans, modified from questionnaires in the literature. Participants respond by indicating if they eat the food item, how frequently (daily, weekly, monthly, yearly, or a few times a year) and serving size (small, medium and large).
12 months
Fruit and vegetable intake
Time Frame: 12 months
National Cancer Institute Fruit and Vegetable Screener is a 10-item instrument that includes respondent assessment of portion size. Scores represent number of servings of fruits and vegetables on a daily basis, ranging from the minimum of zero (0). There is no upper maximum score. The higher the number, the more fruit and vegetable servings consumed daily.
12 months
Fat intake
Time Frame: 12 months
National Cancer Institute Fat Screener is a 16 item instrument that measures percent of energy from fat. Scores can range from 0 percent to 100 percent. The higher percent, the higher percent of energy from fat.
12 months
Self-report Physical activity
Time Frame: 12 months
Yale Physical Activity Scale (YPAS) uses a simple checklist to provide estimates of energy expenditure from activity time (minutes per week) and activity dimensions (e.g., housework, yard work) during a typical day/week. Scores can range from 0 kcal/week minimum to 85,680 kcal/week maximum The higher the kcal/week, the higher the physical activity levels.
12 months
Objective physical activity
Time Frame: 12 months
Wearing of an accelerometer (ActiGraph Corporation, Pensacola, FL) which will be worn on the right hip of each participant for five consecutive days. A wear time of 480 min/day will be used as the criterion for a valid day.
12 months
Blood pressure
Time Frame: 12 months
Three blood pressure readings (systolic and diastolic)
12 months
Weight
Time Frame: 12 months
Weight in kilograms
12 months
Height
Time Frame: 12 months
Height in centimeters
12 months
Hip circumference
Time Frame: 12 months
Measurement of hips in inches using tape measure
12 months
Waist circumference
Time Frame: 12 months
Measurement of waist in inches using tape measure
12 months
Abdomen circumference
Time Frame: 12 months
Measurement of abdomen in inches using tape measure
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of Intervention
Time Frame: 12 months
Costs associated with implementing intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

University of North Carolina, Chapel Hill
University of Georgia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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