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Active, Not Recruiting

NCT Number: NCT06607341

Community Engagement Alliance Against Disparities

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Body Weight Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hypertension Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University, Milken Institute of Public Health, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-level, community-digital health promotion intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. Blood pressure

    Time frame: 6 and 9 months

    Systolic and diastolic blood pressure (mmHg)

  4. Hemoglobin A1c (HbA1c) levels

    Time frame: 6 and 9 months

    Pre-diabetes and diabetes management as assessed by Hemoglobin A1c levels

  5. 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. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Baltimore CONNECT
  • Coaching Salud Holistica
  • La Clinica del Pueblo
  • Rivera Group
  • The Medi Inc.
  • Westat

Registry information

Official study title

Community Engagement ALliance Against Disparities - Washington District of Columbia (DC), Maryland, and Virginia (CEAL-DMV)

Acronym: CEAL-DMV

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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