Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County

NCT05641519 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 483

Last updated 2026-06-22

No results posted yet for this study

Summary

The Skills-Based Educational strategies for Reduction of Vascular Events in Orange County, CA (SERVE OC) study aims to evaluate the efficacy of a culturally tailored, skills-based, cardiovascular health (CVH) intervention amongst a cohort of Latinx and Vietnamese families in Santa Ana, CA. The SERVE OC intervention was adapted from our previous work, the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) intervention, for the primordial prevention of hypertension (HTN) and other risk factors for cardiovascular disease (CVD). (The DESERVE study was conducted at New York University under their IRB). The intervention will be delivered by community health workers (CHWs) and will focus on: 1) optimizing risk perception, 2) enhancing provider-family communication, and 3) identifying challenges to CVH. Participants will receive multi-lingual materials and access to an app/web portal to identify healthy goals and strategies around modifiable risk factors for CVH, Life's Essential 8. SERVE OC will follow participants for 36-months to examine changes in CVH using Life's Simple 7 (LS7): smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure (BP) scores and changes in systolic blood pressure (SBP) among adult participants versus enhanced standard intervention (ESI). Remote blood pressure (BP) monitoring will also be used to assess BP over time. CHWs will engage families in identifying barriers to CVH and solutions to share with community stakeholders. Using this community-based research (CBPR) approach the investigators hope to improve health equity within the community through enhanced social capital, empowerment, and advocacy capacity. This study is part of a multi-center projected coordinated by the UCLA-UCI Center for Eliminating Cardio-Metabolic Disparities in Multi-Ethnic Populations (UC END-DISPARITIES), aimed at improving CVH among underserved populations in Los Angeles and Orange County.

Conditions

Interventions

BEHAVIORAL

SERVE OC Intervention

SERVE OC intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment and discussing prevention/risk reduction 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations such as local churches, parks, community centers, or grocery stores (for field trips) They will also receive messages from them throughout the duration of the study using their preferred method of contact (text, email, webportal/app, phone call) for reinforcement and scheduling meetings

BEHAVIORAL

Enhanced Standard Intervention

Enhanced Standard Intervention will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Ohio State University

    collaborator OTHER
  • Latino Health Access

    collaborator UNKNOWN
  • Vietnamese American Cancer Foundation

    collaborator UNKNOWN
  • Radiate Consulting

    collaborator UNKNOWN
  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Bernadette Boden-Albala, DrPH, MPH · UCI Program in Pubic Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641519 on ClinicalTrials.gov