NCT06607341

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
17mo left

Started Dec 2024

Typical duration for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Dec 2024Sep 2027

First Submitted

Initial submission to the registry

September 1, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

September 1, 2024

Last Update Submit

May 21, 2025

Conditions

Keywords

CEAL-DMVCommunity Engagement AllianceDiabetesHypertensionPre-diabetes

Outcome Measures

Primary Outcomes (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.

    6 and 9 months

Secondary Outcomes (11)

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

    6 and 9 months

  • Body mass index (BMI) in kg/m^2

    6 and 9 months

  • Blood pressure

    6 and 9 months

  • Hemoglobin A1c (HbA1c) levels

    6 and 9 months

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

    6 and 9 months.

  • +6 more secondary outcomes

Study Arms (2)

Multi-level, community-digital health promotion intervention

EXPERIMENTAL

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

Delayed control intervention group

ACTIVE COMPARATOR

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

Interventions

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

Delayed control intervention groupMulti-level, community-digital health promotion intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

George Washington University, Milken Institute of Public Health

Washington D.C., District of Columbia, 20054, United States

RECRUITING

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusGlucose IntoleranceHypertensionOverweightObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaVascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cheryl Himmelfarb, PhD, MSN, BS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Himmelfarb, PhD, MSN, BSc

CONTACT

Cyd Lacanienta, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Randomized delayed control group with phased recruitment design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2024

First Posted

September 23, 2024

Study Start

December 20, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations