Chronic Disease PreventionEPICCNCT06932549
Engaging Partners in Caring Communities
An observational study of Chronic Disease Prevention, run by Tennessee State University at 1 site in United States.
Trial summary
The goal of the EPICC observational study is to learn about capacity to implement evidence-based health promotion programs (EBPs) in congregations that are offered semi-structured technical assistance (TA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease Prevention
- What is being tested?
- Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Apr 2026
- Phase
- Observational
- 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
Study population: Selected congregations are all in Davidson County, TN and self-identify as serving African Americans. The proportion of African Americans considered to be members of the congregation may fluctuate over time and will be estimated by church leaders. Some EB programs are designed to serve families and so there may be individuals participating in EB programs who are minors; however, no data will be obtained from minors.
Who may be able to join
None listed.
Who cannot join
- Individuals who are not enrolled in a health promotion program implemented in an EPICC congregation
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
Tennessee State University
Nashville, Tennessee, 37209
About this study
The goal of the EPICC observational study is to learn about capacity to implement evidence-based health promotion programs (EBPs) in congregations that are offered semi-structured technical assistance (TA). Congregational teams will complete an implementation capacity assessment survey before the TA is offered and 10 months later, after TA has been provided for up to 10 months. Participating congregations will be a convenience sample of congregations in Davidson County, TN that serve primarily African American communities.
Read the detailed description
The recruitment process is designed to provide a team of 3-5 volunteers from 40 congregations with information about five EBPs identified by the research team from which they are to choose one. The team completes one EPICC Survey for their congregation. The team is then offered up to 10 months of TA with the expectation that 2-3 months will be used for planning to launch the EBP, with 4-6 months for implementation. Each congregation will be asked to recruit a minimum of 8-10 members of the congregation to complete a brief report of health behaviors prior to launching of the EBP and repeating that report 6 months later to assess the impact of the EBP on their health behaviors.
- Conditions
- Chronic Disease Prevention
- Being tested
- Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA.
- Keywords
- community-engaged research, health equity, health disparities, implementation science, faith-based organizations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA.Behavioural
The TA is tailored to each congregation using the results of the implementation capacity survey completed by the congregation's team and materials from the EB Program selected by the congregation. The TA teams of two research staff are being trained and coached by Dr. Abe Wandersman, lead developer of Getting To Outcomes-TA (GTO-TA). TA sessions are audio-recorded and will be evaluated for fidelity to GTO-TA, and use of specific ERIC strategies.
| Study group | Role | What they receive |
|---|---|---|
| There will be a single cohort consisting of up to 40 congregations. | The study cohort will consist of up to 40 congregations in Davidson County, TN that that have had a physical location for at least a year, have approval from their leader, and have a tax ID will be eligible for enrollment. Each will be offered up to 10 months of at least 1 hour/month of technical assistance for implementing an evidence-based (EB) chronic disease prevention congregation-level intervention selected by the congregation from five identified by the study team. The study team identified the five EB Programs through a systematic search of federal websites, selecting those programs that address chronic diseases that disproportionately affect African Americans, that can be delivered by non-health care providers in community settings. The selected programs include materials, including facilitator guidance, that are downloadable at no charge Receives: Behavioral: Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engaging Partners in Caring Communities (EPICC) Survey
The EPICC Survey was developed using the Consolidated Framework for Implementation Research (CFIR) and building on other surveys for measuring congregational readiness for health promotion. It consists of
Measured: Congregational teams complete the EPICC Survey at baseline and again 6-10 months later.
Secondary outcomes (1)
My Own Health Report
This is a brief self-reported screening of health-related behavior that will be completed in REDCap. It includes items related to frequency of consumption of fruits, vegetables, and sugary beverages, strenuous exercise, stress, tobacco and alcohol use over the previous 7 days. There are also items about transportation access, housing and food security. Each congregation will be asked to recruit 8-10 individuals who intend to participate in some aspect of the EB Program being implemented by the church. These individuals will be guided to create a unique ID number they can remember so that their reports are anonymous.
Measured: My Own Health Report will be completed when the congregation launches their health promotion program and again 6 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Disease PreventionStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tennessee State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932549
- Sponsor's protocol ID
- #HS2021-4674
- Acronym
- EPICC
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will discuss this with congregations that enroll in the study. They will be given the option of allowing or prohibiting sharing of individual data from My Own Health Report.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Partners in Caring Communities
- ClinicalTrials.gov ID
- NCT06932549
- Acronym / sponsor ID
- EPICC / #HS2021-4674
- Conditions
- Chronic Disease Prevention
- Keywords
- community-engaged research, health equity, health disparities, implementation science, faith-based organizations
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Tennessee State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 17 Apr 2025 (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.
The goal of the EPICC observational study is to learn about capacity to implement evidence-based health promotion programs (EBPs) in congregations that are offered semi-structured technical assistance (TA). Congregational teams will complete an implementation capacity assessment survey before the TA is offered and 10 months later, after TA has been provided for up to 10 months. Participating congregations will be a convenience sample of congregations in Davidson County, TN that serve primarily African American communities.
Detailed description
The recruitment process is designed to provide a team of 3-5 volunteers from 40 congregations with information about five EBPs identified by the research team from which they are to choose one. The team completes one EPICC Survey for their congregation. The team is then offered up to 10 months of TA with the expectation that 2-3 months will be used for planning to launch the EBP, with 4-6 months for implementation. Each congregation will be asked to recruit a minimum of 8-10 members of the congregation to complete a brief report of health behaviors prior to launching of the EBP and repeating that report 6 months later to assess the impact of the EBP on their health behaviors.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| There will be a single cohort consisting of up to 40 congregations. | – | Behavioral: Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA.The study cohort will consist of up to 40 congregations in Davidson County, TN that that have had a physical location for at least a year, have approval from their leader, and have a tax ID will be eligible for enrollment. Each will be offered up to 10 months of at least 1 hour/month of technical assistance for implementing an evidence-based (EB) chronic disease prevention congregation-level intervention selected by the congregation from five identified by the study team. The study team identified the five EB Programs through a systematic search of federal websites, selecting those programs that address chronic diseases that disproportionately affect African Americans, that can be delivered by non-health care providers in community settings. The selected programs include materials, including facilitator guidance, that are downloadable at no charge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Selected congregations are all in Davidson County, TN and self-identify as serving African Americans. The proportion of African Americans considered to be members of the congregation may fluctuate over time and will be estimated by church leaders. Some EB programs are designed to serve families and so there may be individuals participating in EB programs who are minors; however, no data will be obtained from minors.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Individuals who are not enrolled in a health promotion program implemented in an EPICC congregation
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 |
|---|---|---|
| Technical assistance is designed to integrate Expert Recommendations for Implementing Change (ERIC) strategies, and Getting To Outcomes-TA.The TA is tailored to each congregation using the results of the implementation capacity survey completed by the congregation's team and materials from the EB Program selected by the congregation. The TA teams of two research staff are being trained and coached by Dr. Abe Wandersman, lead developer of Getting To Outcomes-TA (GTO-TA). TA sessions are audio-recorded and will be evaluated for fidelity to GTO-TA, and use of specific ERIC strategies. | Behavioural | There will be a single cohort consisting of up to 40 congregations. |
Primary outcome
Engaging Partners in Caring Communities (EPICC) Survey
Time frame: Congregational teams complete the EPICC Survey at baseline and again 6-10 months later.
The EPICC Survey was developed using the Consolidated Framework for Implementation Research (CFIR) and building on other surveys for measuring congregational readiness for health promotion. It consists of
1 secondary outcome
My Own Health Report
Time frame: My Own Health Report will be completed when the congregation launches their health promotion program and again 6 months later.
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 17 Apr 2025.
- The EPICC website is an evolving source of information about the project, and will eventually include information from participating congregations that they ask to have shared.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We will discuss this with congregations that enroll in the study. They will be given the option of allowing or prohibiting sharing of individual data from My Own Health Report.
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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?
An observational study of Chronic Disease Prevention, run by Tennessee 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 0 inclusion and 1 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 17 Apr 2025. 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?
Engaging Partners in Caring Communities (EPICC) Survey (time frame: Congregational teams complete the EPICC Survey at baseline and again 6-10 months later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.