The Health for Hearts United Collaborative

NCT ID: NCT05259150

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Disease Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

effectiveness implementation hybrid Type 3 design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Health for Hearts United Planning for Health

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Health for Hearts United Planning for Health

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Health for Hearts United Comparison Group Health Ministry Development

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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).

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of Georgia

OTHER

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Penny Ralston

Professor, Dean Emeritus & Director, Center on Better Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center on Better Health and Life for Underserved Populations

Tallahassee, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9989687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4014201 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/9989687/

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.

Other Identifiers

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STUDY00000409

Identifier Type: -

Identifier Source: org_study_id

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