Clinical trial NCT06607341: Community Engagement Alliance Against Disparities
Official title: Community Engagement ALliance Against Disparities - Washington District of Columbia (DC), Maryland, and Virginia (CEAL-DMV)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Pre-diabetes
Hypertension
Overweight and Obesity
Keywords: CEAL-DMV
Community Engagement Alliance
Diabetes
Hypertension
Pre-diabetes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Baltimore CONNECT
name: Coaching Salud Holistica
name: La Clinica del Pueblo
name: Rivera Group
name: The Medi Inc.
name: Westat
First posted: 2024-09-23
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized delayed control group with phased recruitment design
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Service utilization as assessed by the number of participants who use referral services
timeFrame: 6 and 9 months
Secondary outcomes:
measure: Satisfaction with health and health-related social services as assessed by a 3-point Likert Scale
timeFrame: 6 and 9 months
measure: Body mass index (BMI) in kg/m^2
timeFrame: 6 and 9 months
measure: Blood pressure
timeFrame: 6 and 9 months
measure: Hemoglobin A1c (HbA1c) levels
timeFrame: 6 and 9 months
measure: Trust in health research and information sources as assessed by the Trust in Medical Research Survey
timeFrame: 6 and 9 months.
measure: Social determinants of health as assessed by the Health Related Social Needs Tool
timeFrame: 6 and 9 months.
measure: Self-reported exercise frequency
timeFrame: 6 and 9 months
measure: Self-reported intake of regular soda or pop that contains sugar.
timeFrame: 6 and 9 months
measure: Self-reported sweetened fruit drinks intake
timeFrame: 6 and 9 months
measure: Self-reported fruit intake
timeFrame: 6 and 9 months
measure: Self-reported intake of green leafy or lettuce salad
timeFrame: 6 and 9 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University, Milken Institute of Public Health
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cheryl Himmelfarb, PhD, MSN, BS
role: PRINCIPAL_INVESTIGATOR
References: