Community Engagement Alliance Against Disparities (CEAL-DMV)

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: Active, not recruiting
• Conditions: Hypertension; Diabetes; Overweight and Obesity; Pre-diabetes
• Intervention / Treatment: Behavioral: Multi-level, community-digital health promotion intervention

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: Interventional
• Enrollment (Estimated): 664
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-level, community-digital health promotion intervention; Participants will receive a multi-level, community-digital health promotion intervention.; Community-level: Community Health Workers will assess needs of individuals including through a survey and facilitate access to the Medi digital resource platform.; 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; 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: Capacity building for community-based organizations, and; Community health workers will facilitate linkage to community resources, including health/social service access referrals and client social support. Individual level activities: Goal setting and self-monitoring,; Tailored feedback,; Personalized lifestyle coaching, health and social service referral support, and; Digital access and digital health literacy skills building Social network: Social network-based activities, and; 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: Capacity building for community-based organizations, and; Community health workers will facilitate linkage to community resources, including health/social service access referrals and client social support. Individual level activities: Goal setting and self-monitoring,; Tailored feedback,; Personalized lifestyle coaching, health and social service referral support, and; Digital access and digital health literacy skills building Social network: Social network-based activities, and; Digital health literacy skills building

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 and 9 months
Body mass index (BMI) in kg/m^2	Body mass index (BMI) in kg/m^2 as assessed by weight-to-height ratio	6 and 9 months
Blood pressure	Systolic and diastolic blood pressure (mmHg)	6 and 9 months
Hemoglobin A1c (HbA1c) levels	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	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	Health Related Social Needs Tool, scores ranging from 0 to 36; higher scored indicate higher need	6 and 9 months.
Self-reported exercise frequency	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.	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	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	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	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

• Sponsor: Johns Hopkins University
• Collaborators: Westat; Baltimore CONNECT; Coaching Salud Holistica; La Clinica del Pueblo; Rivera Group; The Medi Inc.
• Investigators: Principal Investigator: Cheryl Himmelfarb, PhD, MSN, BS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Hypertension; Pre-diabetes; CEAL-DMV; Community Engagement Alliance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperglycemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Diabetes Mellitus; Glucose Intolerance
• Other Study ID 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