Community Engagement Alliance Against Disparities (CEAL-DMV)

May 7, 2026 updated by: Johns Hopkins University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
664

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Cyd Lacanienta, MSW
  • Phone Number: 4106088129
  • Email: clacani1@jh.edu

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20054
        • George Washington University, Milken Institute of Public Health
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multi-level, community-digital health promotion intervention

Participants 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
Behavioral: Multi-level, community-digital health promotion intervention

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
Active Comparator: Delayed control intervention group
At 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.
Behavioral: Multi-level, community-digital health promotion intervention

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Service utilization as assessed by the number of participants who use referral services
Time Frame: 6 and 9 months
Utilization will be calculated by the total number of participants who use services referred to by the community health workers.
6 and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with health and health-related social services as assessed by a 3-point Likert Scale
Time Frame: 6 and 9 months
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).
6 and 9 months
Body mass index (BMI) in kg/m^2
Time Frame: 6 and 9 months
Body mass index (BMI) in kg/m^2 as assessed by weight-to-height ratio
6 and 9 months
Blood pressure
Time Frame: 6 and 9 months
Systolic and diastolic blood pressure (mmHg)
6 and 9 months
Hemoglobin A1c (HbA1c) levels
Time Frame: 6 and 9 months
Pre-diabetes and diabetes management as assessed by Hemoglobin A1c levels
6 and 9 months
Trust in health research and information sources as assessed by the Trust in Medical Research Survey
Time Frame: 6 and 9 months.
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
6 and 9 months.
Social determinants of health as assessed by the Health Related Social Needs Tool
Time Frame: 6 and 9 months.
Health Related Social Needs Tool, scores ranging from 0 to 36; higher scored indicate higher need
6 and 9 months.
Self-reported exercise frequency
Time Frame: 6 and 9 months
Exercise frequency will be assessed by number of days per week a participant engages in moderate to strenuous exercise
6 and 9 months
Self-reported intake of regular soda or pop that contains sugar.
Time Frame: 6 and 9 months
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.
6 and 9 months
Self-reported sweetened fruit drinks intake
Time Frame: 6 and 9 months
Participants will report the number of times they consumed sweetened fruit drinks per week. Higher number of times/week represents a worse outcome.
6 and 9 months
Self-reported fruit intake
Time Frame: 6 and 9 months
Participants will report the frequency of consumption of fruits per week. Higher number of times/week represents a better outcome.
6 and 9 months
Self-reported intake of green leafy or lettuce salad
Time Frame: 6 and 9 months
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.
6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Westat
Baltimore CONNECT
Coaching Salud Holistica
La Clinica del Pueblo
Rivera Group
The Medi Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheryl Himmelfarb, PhD, MSN, BS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00338867
  • 6922-03-COVID-S017 (Other Grant/Funding Number: Westat Inc./NIH-NHLBI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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