The Health for Hearts United Collaborative
HHUC
1 other identifier
interventional
225
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2021
CompletedStudy Start
First participant enrolled
January 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 2, 2026
April 1, 2026
6 years
November 18, 2021
April 1, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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
Intervention Adoption
Number of participants who attend intervention sessions which is computed by adding the number of attendees to create total attendance.
12 months
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
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 Outcomes (11)
Food choice
12 months
Fruit and vegetable intake
12 months
Fat intake
12 months
Self-report Physical activity
12 months
Objective physical activity
12 months
- +6 more secondary outcomes
Other Outcomes (1)
Cost of Intervention
12 months
Study Arms (3)
Internal Champion (IC) Strategy
EXPERIMENTALIn 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.
Expert Professional (EP) Strategy
EXPERIMENTALIn 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.
Comparison Group Strategy
ACTIVE COMPARATORIn 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.
Interventions
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.
The Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices).
Participants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program.
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.
Eligibility Criteria
You may qualify if:
- African American,
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida State Universitylead
- University of Georgiacollaborator
- University of North Carolina, Chapel Hillcollaborator
Study Sites (1)
Center on Better Health and Life for Underserved Populations
Tallahassee, Florida, 32306, United States
Related 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.
PMID: 9989687BACKGROUNDWillett 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.
PMID: 4014201BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Dean Emeritus & Director, Center on Better Health
Study Record Dates
First Submitted
November 18, 2021
First Posted
February 28, 2022
Study Start
January 15, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 2, 2026
Record last verified: 2026-04