The Health for Hearts United Collaborative

Cardiovascular Disease Risk Reduction Clinical Trial

— HHUC  

Official title:

The Health for Hearts United Collaborative

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05259150
• Other study ID #: STUDY00000409
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2024
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 225
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Reduction
• Cardiovascular Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Center on Better Health and Life for Underserved Populations	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	University of Georgia, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hu FB, Rimm E, Smith-Warner SA, Feskanich D, Stampfer MJ, Ascherio A, Sampson L, Willett WC. Reproducibility and validity of dietary patterns assessed with a food-frequency questionnaire. Am J Clin Nutr. 1999 Feb;69(2):243-9. doi: 10.1093/ajcn/69.2.243. — View Citation

Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65. doi: 10.1093/oxfordjournals.aje.a114086. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of Intervention	Costs associated with implementing intervention	12 months
Primary	Participant Reach	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
Primary	Intervention Adoption	Number of participants who attend intervention sessions which is computed by adding the number of attendees to create total attendance.	12 months
Primary	Intervention Implementation	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
Primary	Intervention Maintenance	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	Food choice	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
Secondary	Fruit and vegetable intake	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
Secondary	Fat intake	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
Secondary	Self-report Physical activity	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
Secondary	Objective physical activity	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
Secondary	Blood pressure	Three blood pressure readings (systolic and diastolic)	12 months
Secondary	Weight	Weight in kilograms	12 months
Secondary	Height	Height in centimeters	12 months
Secondary	Hip circumference	Measurement of hips in inches using tape measure	12 months
Secondary	Waist circumference	Measurement of waist in inches using tape measure	12 months
Secondary	Abdomen circumference	Measurement of abdomen in inches using tape measure	12 months

External Links

•   Hu FB, Rimm E, Smith-Warner SA, Feskanich D, Stampfer MJ, Ascherio A, Sampson L, Willett WC. Reproducibility and validity of dietary patterns assessed with a food-frequency questionnaire. Am J Clin Nutr. 1999 Feb;69(2):243-9.
•   Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65.