Mental HealthCO-CEALNCT07440316
Colorado Community Engagement Alliance
An observational study of Mental Health and Hypertension, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The Colorado Community Engagement Alliance (CO-CEAL) is a partnership between the University of Colorado Anschutz Medical Campus, several community-based organizations, and dozens of trusted local community members. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Hypertension, Diabetes
- What is being tested?
- Individual awareness and focused behavior change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2025to 30 Jun 2027
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals meeting inclusion criteria from 5 regions in Colorado including the: Rural and Urban Latina/o/x communities in the Metro Denver area, Pueblo, and San Luis Valley, Urban American Indian/Alaska Native community in Metro Denver and along the Front Range, Rural East African immigrant community in Greeley and Ft. Morgan, and Urban Black/African American community in Metro Denver.
Who may be able to join
- 18 years of age through 90 years of age
- All genders
- Identify as Black/African American, East African, Latina/o/x/Hispanic, American Indian/Alaska Native
- Live in a participating region (Metro Denver, Pueblo, San Luis Valley, Front Range, Fort Morgan, Greeley)
Who cannot join
- Greater than 90 years of age
- Individuals younger than 18 years of age
- Individuals not identifying as Black/African American, East African, Latina/o/x/Hispanic, or American Indian/Alaska Native
- Individuals who do not live in a participating region (Metro Denver, Pueblo, San Luis Valley, Front Range, Fort Morgan, Greeley)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Montelle Tamez contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Donald Nease, Jr., MD, 303-724-7283, donald.nease@cuanschutz.edu
Montelle Tamez, montelle.tamez@cuanschutz.edu
About this study
The Colorado Community Engagement Alliance (CO-CEAL) is a partnership between the University of Colorado Anschutz Medical Campus, several community-based organizations, and dozens of trusted local community members. Its mission is to address disproportionate impacts on health through active community engagement and outreach, capacity building, and long-lasting community partnerships to improve participation in health research. Funding for CEAL comes from the National Institutes of Health (NIH).
Read the detailed description
CO-CEAL seeks to strengthen the translation of medical knowledge and scientific evidence into sustainable, culturally relevant practices and messages that resonate with communities. The initiative also aims to build capacity among community members and foster partnerships both between communities and the University and within communities themselves.
CO-CEAL uses the Transcreational Framework to engage with 5 communities in urban and rural Colorado to co-identify and co-address chronic disease-related issues with interventions that align with community cultural norms and values. CO-CEAL uses Group Model Building (GMB) to identify leverage points in each community and uses the Boot Camp/Community Translation (BCT) process to transcreate and disseminate messages and interventions related to chronic disease and mental health using a variety of mediums. CO-CEAL collaborates with community members, identified for their status as trusted messengers and having strong community connections, to build networks of community members from various sectors/roles to participate in project activities, including Boot Camp Translation, data collection, and participatory community meetings.
- Conditions
- Mental Health, Hypertension, Diabetes
- Being tested
- Individual awareness and focused behavior change
- Keywords
- Community engaged research, Transcreation, Boot Camp Translation, Chronic disease, Systems thinking
- Medical subject headings
- Psychological Well-Being, Hypertension, Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual awareness and focused behavior changeBehavioural
Transcreation of existing or new behavioral/knowledge-focused intervention.
| Study group | Role | What they receive |
|---|---|---|
| Urban Latina/o/x | Urban Latina/o/x in Metro Denver and Pueblo Receives: Behavioral: Individual awareness and focused behavior change | |
| Rural Latina/o/x | Rural Latina/o/x in the San Luis Valley Receives: Behavioral: Individual awareness and focused behavior change | |
| Urban Black/African American | Urban Black/African American in Metro Denver Receives: Behavioral: Individual awareness and focused behavior change | |
| Rural East African | Rural East African immigrant in Fort Morgan and Greeley Receives: Behavioral: Individual awareness and focused behavior change | |
| American Indian/Alaska Native | American Indian/Alaska Native in Metro Denver and Boulder Receives: Behavioral: Individual awareness and focused behavior change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of respondents reporting how many times per week over the past month do they eat a green leafy or lettuce salad, with or without other vegetables as measured by Common Survey 4.
Response options are on a scale of "Never" to "More than 6 times per week". Change indicates an increase or decrease of the number of times per week a respondent eats leafy greens.
Measured: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years
Change in the number of respondents reporting a lack of reliable transportation over the past 12 months that keeps them from medical appointments, meetings, work, or getting things they need for daily living as measured by Common Survey 4.
Response options are "Yes" and "No". Change is indicated by moving from "Yes" to "No" and vice versa; "Yes" indicates respondent does not have reliable transportation for such activities; "No" indicates respondent has reliable transportation for such activities.
Measured: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years
Change in the number of respondents reporting getting the social and emotional support they need as measured by Common Survey 4.
Response options are on a scale of "Never" to "Always" to describe how often they receive the social and emotional support they need. Change is indicated by moving from receiving support less frequently to receiving support more frequently (e.g., moving from "Rarely" to "Sometimes").
Measured: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440316
- Sponsor's protocol ID
- 21-3647
- Other IDs
- OT2HL158287
- Acronym
- CO-CEAL
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorado Community Engagement Alliance
- ClinicalTrials.gov ID
- NCT07440316
- Acronym / sponsor ID
- CO-CEAL / 21-3647
- Conditions
- Mental Health, Hypertension, Diabetes
- Keywords
- Community engaged research, Transcreation, Boot Camp Translation, Chronic disease, Systems thinking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Feb 2026 (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 Colorado Community Engagement Alliance (CO-CEAL) is a partnership between the University of Colorado Anschutz Medical Campus, several community-based organizations, and dozens of trusted local community members. Its mission is to address disproportionate impacts on health through active community engagement and outreach, capacity building, and long-lasting community partnerships to improve participation in health research. Funding for CEAL comes from the National Institutes of Health (NIH).
Detailed description
CO-CEAL seeks to strengthen the translation of medical knowledge and scientific evidence into sustainable, culturally relevant practices and messages that resonate with communities. The initiative also aims to build capacity among community members and foster partnerships both between communities and the University and within communities themselves.
CO-CEAL uses the Transcreational Framework to engage with 5 communities in urban and rural Colorado to co-identify and co-address chronic disease-related issues with interventions that align with community cultural norms and values. CO-CEAL uses Group Model Building (GMB) to identify leverage points in each community and uses the Boot Camp/Community Translation (BCT) process to transcreate and disseminate messages and interventions related to chronic disease and mental health using a variety of mediums. CO-CEAL collaborates with community members, identified for their status as trusted messengers and having strong community connections, to build networks of community members from various sectors/roles to participate in project activities, including Boot Camp Translation, data collection, and participatory community meetings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Urban Latina/o/x | – | Behavioral: Individual awareness and focused behavior changeUrban Latina/o/x in Metro Denver and Pueblo |
| Rural Latina/o/x | – | Behavioral: Individual awareness and focused behavior changeRural Latina/o/x in the San Luis Valley |
| Urban Black/African American | – | Behavioral: Individual awareness and focused behavior changeUrban Black/African American in Metro Denver |
| Rural East African | – | Behavioral: Individual awareness and focused behavior changeRural East African immigrant in Fort Morgan and Greeley |
| American Indian/Alaska Native | – | Behavioral: Individual awareness and focused behavior changeAmerican Indian/Alaska Native in Metro Denver and Boulder |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals meeting inclusion criteria from 5 regions in Colorado including the: Rural and Urban Latina/o/x communities in the Metro Denver area, Pueblo, and San Luis Valley, Urban American Indian/Alaska Native community in Metro Denver and along the Front Range, Rural East African immigrant community in Greeley and Ft. Morgan, and Urban Black/African American community in Metro Denver.
Key inclusion criteria (4 listed)
- 18 years of age through 90 years of age
- All genders
- Identify as Black/African American, East African, Latina/o/x/Hispanic, American Indian/Alaska Native
- Live in a participating region (Metro Denver, Pueblo, San Luis Valley, Front Range, Fort Morgan, Greeley)
Key exclusion criteria (4 listed)
- Greater than 90 years of age
- Individuals younger than 18 years of age
- Individuals not identifying as Black/African American, East African, Latina/o/x/Hispanic, or American Indian/Alaska Native
- Individuals who do not live in a participating region (Metro Denver, Pueblo, San Luis Valley, Front Range, Fort Morgan, Greeley)
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 |
|---|---|---|
| Individual awareness and focused behavior changeTranscreation of existing or new behavioral/knowledge-focused intervention. | Behavioural | American Indian/Alaska Native, Rural East African, Rural Latina/o/x, Urban Black/African American, Urban Latina/o/x |
Primary outcome
Change in the number of respondents reporting how many times per week over the past month do they eat a green leafy or lettuce salad, with or without other vegetables as measured by Common Survey 4.
Time frame: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years
Response options are on a scale of "Never" to "More than 6 times per week". Change indicates an increase or decrease of the number of times per week a respondent eats leafy greens.
Change in the number of respondents reporting a lack of reliable transportation over the past 12 months that keeps them from medical appointments, meetings, work, or getting things they need for daily living as measured by Common Survey 4.
Time frame: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years
Response options are "Yes" and "No". Change is indicated by moving from "Yes" to "No" and vice versa; "Yes" indicates respondent does not have reliable transportation for such activities; "No" indicates respondent has reliable transportation for such activities.
Change in the number of respondents reporting getting the social and emotional support they need as measured by Common Survey 4.
Time frame: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years
Response options are on a scale of "Never" to "Always" to describe how often they receive the social and emotional support they need. Change is indicated by moving from receiving support less frequently to receiving support more frequently (e.g., moving from "Rarely" to "Sometimes").
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 27 Feb 2026.
- Individual participant dataSharing planned: No. We will share aggregated data.
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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.
Montelle Tamez contact
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 Mental Health and Hypertension, run by University of Colorado, Denver 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
Contact Donald Nease, Jr., MD (303.724.7283, donald.nease@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of respondents reporting how many times per week over the past month do they eat a green leafy or lettuce salad, with or without other vegetables as measured by Common Survey 4. (time frame: From Baseline Common Survey 4 to Follow-Up Common Survey 4, up to 2 years). The study lists 3 primary outcomes in all. 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 27 Feb 2026.