Project Summary/Abstract
Louisiana residents, especially African Americans, bear a disproportionately high burden of atherosclerotic
cardiovascular disease (ASCVD). In the proposed cluster randomized trial, we will test whether a multifaceted
strategy for implementing the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease
will reduce cardiovascular health disparities in African Americans from 42 black churches in New Orleans and
Bogalusa, Louisiana. The proposed study will utilize an effectiveness-implementation hybrid design to 1). test
the effectiveness of a community health worker (CHW)-led church-based multifaceted implementation strategy
for improving cardiovascular health over 18 months among African Americans at high risk for ASCVD, and 2).
assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-
effectiveness, and sustainability) of the multifaceted strategy simultaneously. The RE-AIM framework has
guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led
health coaching on lifestyle changes and medication adherence; church-based exercise and weight loss
programs; self-monitoring of physical activity, blood pressure (BP), and glucose; and provider education and
engagement. The primary effectiveness outcome is the difference in the proportion of participants having =4
ideal or improved cardiovascular health metrics (CHMs), defined as a healthy diet score of 4-5 components or
increase of 2 components from baseline; 150 minutes/week moderate- or 75 minutes/week vigorous-intensity
physical activity or a combination; never smoking or quitting =6 months ago; body mass index <25 kg/m2 or
weight loss =10 pounds; A1c <7.0% (or <8.0% with complications); use of statin therapy as appropriate; and
BP <130/80 mmHg or systolic BP reduced by =10 mmHg. Our study has 90% statistical power to detect an
absolute difference of 15% in the primary effectiveness outcome at 18 months using a 2-sided significance
level of 0.05. In the planning phase, we will work with stakeholders to ensure the multifaceted implementation
strategy is responsive to African American community needs; we will identify 42 black churches as research
partners and conduct a health needs assessment; and we will develop the study protocol and obtain approval
from the NIH, DSMB, and IRB. In the implementation phase, we will recruit 1,050 African American participants
(25 per church) aged =40 years who have <4 ideal CHMs and randomly assign 21 churches to intervention
and 21 to control; we will implement the multifaceted intervention program; we will follow-up participants and
collect data on effectiveness and implementation outcomes at 6, 12, and 18 months; we will evaluate the
sustainability of the intervention in a 6-month post-intervention study; and we will perform intention-to-treat
analyses and disseminate and scale-up the proven-effective implementation strategy. The proposed study will
generate evidence on the effectiveness, implementation, and sustainability of the multifaceted intervention
aimed at eliminating cardiovascular health disparities in high-burden populations in the US.
