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DiabetesCEAL-DMVNCT06607341

Community Engagement Alliance Against Disparities

A study testing Multi-level, community-digital health promotion intervention in people with Diabetes and Pre-diabetes, run by Johns Hopkins University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The Community Engagement Alliance against Disparities - Washington District of Columbia, Maryland, Virginia (CEAL DMV), is a multi-community and multi-university consortium. Through collaboration and shared leadership, the CEAL-DMV the consortium- comprising five institutions: George Washington University, Howard… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Pre-diabetes, Hypertension
What is being tested?
Multi-level, community-digital health promotion intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
664 participants
Where
2 sitesUnited States
Study dates
20 Dec 2024to 30 Sep 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-identify as Black or Latino
  • Age 18 years or older
  • Reside in defined geographic area
  • Diagnosis of one or more target conditions: Prediabetes/Diabetes (HbA1c 5.7%), Hypertension (≥130/80 mm Hg), Overweight/obesity (BMI >25 kg/m^2)

Who cannot join

  • Unable to provide informed consent
  • No access to phone/internet

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins University School of Nursing

    Baltimore, Maryland, 21205

  • George Washington University, Milken Institute of Public Health

    Washington D.C., District of Columbia, 20054

Other trials in United States

About this study

Official title: Community Engagement ALliance Against Disparities - Washington District of Columbia (DC), Maryland, and Virginia (CEAL-DMV)

The Community Engagement Alliance against Disparities - Washington District of Columbia, Maryland, Virginia (CEAL DMV), is a multi-community and multi-university consortium. Through collaboration and shared leadership, the CEAL-DMV the consortium- comprising five institutions: George Washington University, Howard University, Johns Hopkins University, Morgan State University, and the University of Maryland, Baltimore-has established a regional structure for bi-directional community involvement to engender trust and foster communication. Each site builds on thriving community partnerships, which have been instrumental in enhancing trust, community capacity, and readiness to reduce health disparities.

Read the detailed description

The investigators propose to evaluate the effect of a multi-level, community-digital health promotion intervention, compared to delayed control intervention, at improving health and social service utilization, and the prevention and management of hypertension, diabetes, overweight and obesity. The evidence-based intervention is based on substantial evidence supporting the role of Community Health Workers in health promotion and reduction of risks associated with chronic diseases.

Studies have demonstrated community health worker (CHW) intervention success at improving chronic disease risks and management, including for hypertension and diabetes, through support in implementing clinical recommendations, overcoming barriers to lifestyle behavior change, achieving personal goals, and preventing complications. Additionally, there is substantial evidence supporting digital approaches for the prevention and management of cardiometabolic diseases. The proposed intervention and methods also build on almost three years of CEAL DMV collaboration with community partners. At the community level, core activities will focus on capacity building to ensure the trusted community-based organization partners are fully supported in the implementation of community-digital strategies to address hypertension, diabetes, overweight and obesity.

Being tested
Multi-level, community-digital health promotion intervention
Keywords
CEAL-DMV, Community Engagement Alliance, Diabetes, Hypertension, Pre-diabetes
Medical subject headings
Diabetes Mellitus, Glucose Intolerance, Hypertension, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-level, community-digital health promotion interventionBehavioural

    Community level activities:

    1. Capacity building for community-based organizations, and
    2. Community health workers will facilitate linkage to community resources, including health/social service access referrals and client social support.

    Individual level activities:

    1. Goal setting and self-monitoring,
    2. Tailored feedback,
    3. Personalized lifestyle coaching, health and social service referral support, and
    4. Digital access and digital health literacy skills building

    Social network:

    1. Social network-based activities, and
    2. Digital health literacy skills building
Study groups in NCT06607341
Study groupRoleWhat they receive
Multi-level, community-digital health promotion interventionExperimentalParticipants will receive a multi-level, community-digital health promotion intervention. 1. Community-level: Community Health Workers will assess needs of individuals including through a survey and facilitate access to the Medi digital resource platform. 2. Individual level: CHW-delivered coaching on behavior-change goals and facilitation to services via the Medi platform. Participants will also receive tailored social media and in person reinforcements and cues to action based on goal attainment 3. Social network level: Participants will receive tailored recommendations sent via social media on nearby parks, recreational facilities, faith-based ministries, and peer groups to support behavior change goals
Receives: Behavioral: Multi-level, community-digital health promotion intervention
Delayed control intervention groupActive comparatorAt the individual level, participants will receive standardized 12-month text message (SMS) campaign. At the community-level, the investigators will equip community-based organization partners and community health workers with chronic disease educational content. Participants will also receive recommendations for health events and fairs locally.
Receives: Behavioral: Multi-level, community-digital health promotion intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Service utilization as assessed by the number of participants who use referral services

    Utilization will be calculated by the total number of participants who use services referred to by the community health workers.

    Measured: 6 and 9 months

Secondary outcomes (11)

  1. Satisfaction with health and health-related social services as assessed by a 3-point Likert Scale

    Participants who utilize health and/or social services will be asked if satisfied with services received from health workers (i.e health care providers, mental health professionals and community health workers) using a a 3 point likert scale ranging from 1-3. Higher values would imply higher satisfaction).

    Measured: 6 and 9 months

  2. Body mass index (BMI) in kg/m^2

    Body mass index (BMI) in kg/m^2 as assessed by weight-to-height ratio

    Measured: 6 and 9 months

  3. Blood pressure

    Systolic and diastolic blood pressure (mmHg)

    Measured: 6 and 9 months

  4. Hemoglobin A1c (HbA1c) levels

    Pre-diabetes and diabetes management as assessed by Hemoglobin A1c levels

    Measured: 6 and 9 months

  5. Trust in health research and information sources as assessed by the Trust in Medical Research Survey

    Trust in Medical Research Survey, distrust sub-scale ranges from 0 to 20 with lower scores indicating better trust; trust sub-scale ranges from 0 to 24, higher scores mean better trust

    Measured: 6 and 9 months.

  6. Social determinants of health as assessed by the Health Related Social Needs Tool

    Health Related Social Needs Tool, scores ranging from 0 to 36; higher scored indicate higher need

    Measured: 6 and 9 months.

  7. Self-reported exercise frequency

    Exercise frequency will be assessed by number of days per week a participant engages in moderate to strenuous exercise

    Measured: 6 and 9 months

  8. Self-reported intake of regular soda or pop that contains sugar.

    Participants will report the frequency of consumption of regular soda or pop that contains sugar each week. Higher number of times/week represents a worse outcome.

    Measured: 6 and 9 months

  9. Self-reported sweetened fruit drinks intake

    Participants will report the number of times they consumed sweetened fruit drinks per week. Higher number of times/week represents a worse outcome.

    Measured: 6 and 9 months

  10. Self-reported fruit intake

    Participants will report the frequency of consumption of fruits per week. Higher number of times/week represents a better outcome.

    Measured: 6 and 9 months

  11. Self-reported intake of green leafy or lettuce salad

    Participants will report the frequency of consumption of green leafy or lettuce salad each week. Higher number of number of times/week represents a better outcome.

    Measured: 6 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start20 Dec 2024
  3. Primary completion20 Dec 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Sequential
Model description
Randomized delayed control group with phased recruitment design
Masking
None (open label)
Enrolment
664 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06607341
Sponsor's protocol ID
IRB00338867
Other IDs
6922-03-COVID-S017
Acronym
CEAL-DMV
Status last verified
May 2026
First submitted
1 Sep 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Himmelfarb CR, Chepkorir J, Miller HN, Ogungbe O, Perrin N, Olawole W, Cain G, Kinlock BL, Mullins CD, Kutcherman I, Barger P, Diaz-Ramirez M, Rodriguez J, Trujillo R, Gonzalez-Salinas A, Clark R, Andrade EL. A Multisite, Randomized Trial Testing a Community-Digital Health Intervention among Black and Latino Adults with Cardiometabolic Conditions: The Roots of Wellness (Raices del Bienestar) Protocol. medRxiv [Preprint]. 2026 May 27:2026.05.26.26354175. doi: 10.64898/2026.05.26.26354175.

    PubMed 42245006

Questions about this trial

What is this clinical trial studying?

A study testing Multi-level, community-digital health promotion intervention in people with Diabetes and Pre-diabetes, run by Johns Hopkins University at 2 sites 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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Service utilization as assessed by the number of participants who use referral services (time frame: 6 and 9 months). 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 NCT06607341, which also lists 1 linked publication.

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 11 May 2026.

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