Cardiovascular Disease Risk ReductionHHUCNCT05259150
The Health for Hearts United Collaborative
A study testing Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health and Health for Hearts United Delivery of Health in people with Cardiovascular Disease Risk Reduction, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk Reduction
- What is being tested?
- Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health and Health for Hearts United Delivery of Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Center on Better Health and Life for Underserved Populations
Tallahassee, Florida, 32306
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Disease Risk Reduction
- Being tested
- Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health, Health for Hearts United Delivery of Health, Health for Hearts United Comparison Group Health Ministry Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health for Hearts United Planning for HealthBehavioural
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 HealthBehavioural
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 HealthBehavioural
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 DevelopmentOther
Participants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program.
| Study group | Role | What they receive |
|---|---|---|
| Internal Champion (IC) Strategy | Experimental | 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. Receives: Behavioral: Health for Hearts United Planning for Health; Behavioral: Health for Hearts United Preparing for Health; Behavioral: Health for Hearts United Delivery of Health |
| Expert Professional (EP) Strategy | Experimental | 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. Receives: Behavioral: Health for Hearts United Planning for Health; Behavioral: Health for Hearts United Preparing for Health; Behavioral: Health for Hearts United Delivery of Health |
| Comparison Group Strategy | Active comparator | 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. Receives: Other: Health for Hearts United Comparison Group Health Ministry Development |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Intervention Adoption
Number of participants who attend intervention sessions which is computed by adding the number of attendees to create total attendance.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Blood pressure
Three blood pressure readings (systolic and diastolic)
Measured: 12 months
Weight
Weight in kilograms
Measured: 12 months
Height
Height in centimeters
Measured: 12 months
Hip circumference
Measurement of hips in inches using tape measure
Measured: 12 months
Waist circumference
Measurement of waist in inches using tape measure
Measured: 12 months
Abdomen circumference
Measurement of abdomen in inches using tape measure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start15 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- effectiveness implementation hybrid Type 3 design
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Georgia
- Responsible party
- Principal investigator, Penny Ralston, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259150
- Sponsor's protocol ID
- STUDY00000409
- Acronym
- HHUC
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9989687Willett 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.
PubMed 4014201
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health for Hearts United Collaborative
- ClinicalTrials.gov ID
- NCT05259150
- Acronym / sponsor ID
- HHUC / STUDY00000409
- Conditions
- Cardiovascular Disease Risk Reduction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Georgia
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- effectiveness implementation hybrid Type 3 design
| Arm | Type | Receives |
|---|---|---|
| Internal Champion (IC) Strategy | Experimental | Behavioral: Health for Hearts United Planning for Health, Behavioral: Health for Hearts United Preparing for Health, Behavioral: Health for Hearts United Delivery of HealthIn 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 | Experimental | Behavioral: Health for Hearts United Planning for Health, Behavioral: Health for Hearts United Preparing for Health, Behavioral: Health for Hearts United Delivery of HealthIn 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 comparator | Other: Health for Hearts United Comparison Group Health Ministry DevelopmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health for Hearts United Planning for HealthParticipants (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. | Behavioural | Expert Professional (EP) Strategy, Internal Champion (IC) Strategy |
| Health for Hearts United Preparing for HealthResearch 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. | Behavioural | Expert Professional (EP) Strategy, Internal Champion (IC) Strategy |
| Health for Hearts United Delivery of HealthThe Organization (church) uses best practices to implement Heart Health activities (annual plans, achievements, plans for the year and practices). | Behavioural | Expert Professional (EP) Strategy, Internal Champion (IC) Strategy |
| Health for Hearts United Comparison Group Health Ministry DevelopmentParticipants (health leaders) have meetings to develop the health ministry. Research participants (church congregants) do not receive cardiovascular health program. | Other | Comparison Group Strategy |
Primary outcome
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.
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.
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.
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.
11 secondary outcomes
Food choice
Time frame: 12 months
Fruit and vegetable intake
Time frame: 12 months
Fat intake
Time frame: 12 months
Self-report Physical activity
Time frame: 12 months
Objective physical activity
Time frame: 12 months
Blood pressure
Time frame: 12 months
Weight
Time frame: 12 months
Height
Time frame: 12 months
Hip circumference
Time frame: 12 months
Waist circumference
Time frame: 12 months
Abdomen circumference
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 9989687Hu 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.
- Background: PubMed 4014201Willett 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health and Health for Hearts United Delivery of Health in people with Cardiovascular Disease Risk Reduction, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Reach (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259150, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.