The Health for Hearts United Collaborative

Study Overview
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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.

Official Title
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The Health for Hearts United Collaborative

Conditions
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Cardiovascular Disease Risk Reduction

Intervention / Treatment
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* Behavioral: Health for Hearts United Planning for Health
* Behavioral: Health for Hearts United Preparing for Health
* Behavioral: Health for Hearts United Delivery of Health
* Other: Health for Hearts United Comparison Group Health Ministry Development


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: effectiveness implementation hybrid Type 3 design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internal Champion (IC) Strategy<br>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<br>* 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.<br>Behavioral: Health for Hearts United Preparing for Health<br>* 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.<br>Behavioral: Health for Hearts United Delivery of Health<br>* The Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices).<br>|
| Experimental: Expert Professional (EP) Strategy<br>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<br>* 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.<br>Behavioral: Health for Hearts United Preparing for Health<br>* 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.<br>Behavioral: Health for Hearts United Delivery of Health<br>* The Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices).<br>|
| Active Comparator: Comparison Group Strategy<br>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<br>* Participants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Blood pressure | Three blood pressure readings (systolic and diastolic) | 12 months | 
| Weight | Weight in kilograms | 12 months | 
| Height | Height in centimeters | 12 months | 
| Hip circumference | Measurement of hips in inches using tape measure | 12 months | 
| Waist circumference | Measurement of waist in inches using tape measure | 12 months | 
| Abdomen circumference | Measurement of abdomen in inches using tape measure | 12 months |