Community Engagement Alliance Against Disparities
- Conditions
- DiabetesPre-diabetesHypertensionOverweight and Obesity
- Interventions
- Behavioral: Multi-level, community-digital health promotion intervention
- Registration Number
- NCT06607341
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 664
- 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)
- Unable to provide informed consent
- No access to phone/internet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Multi-level, community-digital health promotion intervention Multi-level, community-digital health promotion intervention 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 Delayed control intervention group Multi-level, community-digital health promotion intervention 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.
- Primary Outcome Measures
Name Time Method Service utilization as assessed by the number of participants who use referral services 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 Outcome Measures
Name Time Method Satisfaction with health and health-related social services as assessed by a 3-point Likert Scale 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).
Body mass index (BMI) in kg/m^2 6 and 9 months Body mass index (BMI) in kg/m\^2 as assessed by weight-to-height ratio
Blood pressure 6 and 9 months Systolic and diastolic blood pressure (mmHg)
Hemoglobin A1c (HbA1c) levels 6 and 9 months Pre-diabetes and diabetes management as assessed by Hemoglobin A1c levels
Trust in health research and information sources as assessed by the Trust in Medical Research Survey 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
Social determinants of health as assessed by the Health Related Social Needs Tool 6 and 9 months. Health Related Social Needs Tool, scores ranging from 0 to 36; higher scored indicate higher need
Self-reported exercise frequency 6 and 9 months Exercise frequency will be assessed by number of days per week a participant engages in moderate to strenuous exercise
Self-reported intake of regular soda or pop that contains sugar. 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.
Self-reported sweetened fruit drinks intake 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.
Self-reported fruit intake 6 and 9 months Participants will report the frequency of consumption of fruits per week. Higher number of times/week represents a better outcome.
Self-reported intake of green leafy or lettuce salad 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.
Trial Locations
- Locations (2)
George Washington University, Milken Institute of Public Health
🇺🇸Washington, District of Columbia, United States
Johns Hopkins University School of Nursing
🇺🇸Baltimore, Maryland, United States