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Enrolling by Invitation

NCT Number: NCT05259150

The Health for Hearts United Collaborative

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.

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Key information

Conditions

Cardiovascular Disease Risk Reduction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center on Better Health and Life for Underserved Populations

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health for Hearts United Planning for Health

Behavioral

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.

Health for Hearts United Preparing for Health

Behavioral

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.

Health for Hearts United Delivery of Health

Behavioral

The Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices).

Health for Hearts United Comparison Group Health Ministry Development

Other

Participants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Blood pressure

    Time frame: 12 months

    Three blood pressure readings (systolic and diastolic)

  7. Weight

    Time frame: 12 months

    Weight in kilograms

  8. Height

    Time frame: 12 months

    Height in centimeters

  9. Hip circumference

    Time frame: 12 months

    Measurement of hips in inches using tape measure

  10. Waist circumference

    Time frame: 12 months

    Measurement of waist in inches using tape measure

  11. Abdomen circumference

    Time frame: 12 months

    Measurement of abdomen in inches using tape measure

Other outcomes

  1. Cost of Intervention

    Time frame: 12 months

    Costs associated with implementing intervention

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • University of Georgia
  • University of North Carolina, Chapel Hill

Registry information

Acronym: HHUC

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.

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