Community Engagement Alliance Against Disparities (CEAL-DMV)

Johns Hopkins University

Status: Enrolling

Conditions: Hypertension; Diabetes; Pre-diabetes; Overweight and Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06607341

6922-03-COVID-S017 (Other Grant/Funding Number)

IRB00338867

Details and patient eligibility

About

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.

Full 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.

Enrollment: 664 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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664 participants in 2 patient groups

Multi-level, community-digital health promotion intervention

Experimental group

Description:

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

Treatment:

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

Delayed control intervention group

Active Comparator group

Description:

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.

Treatment:

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