We propose a three part study to: 1) develop two nutrition intervention modules for southern patients with low literacy skills that are designed to reduce the risk of cardiovascular disease, 2) test the efficacy of these modules against standard care in a randomized, controlled, clinical trial, and 3) determine the feasibility of disseminating these interventions to worksites, churches, and county health departments through the state health department system. The study is divided into three phases which address each of these aims. The goal of Phase I is to develop two innovative care modules that use demographic, psycho-social, nutritional, and behavioral information to individually tailor nutrition treatment programs for southern patients with less than ninth grade reading skills. Counselor Directed innovative care consists of a structured assessment and intervention package of simply written, graphically-oriented printed materials to guide the patient and health counselor (nutritionist, health educator, nurse, or physician). Computer Assisted innovative care makes use of a user-friendly, interactive, computer assisted program permitting more sophisticated tailoring to individual needs, conveying nutrition information in a vivid, understandable format, and extending the services of the health counselor. We will use focus groups of patients with low literacy skills to aid in concept development and refinement of intervention delivery strategies. Reliable and valid assessments of readability and comprehension will help us further refine the materials. In Phase II, we will conduct a randomized trial to determine if our innovative modules produce a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard care. We will identify 400 patients with high cholesterol and low literacy skills served by four community health centers and will randomly assign them to one of four groups: Innovative Care-Counselor Directed, Innovative Care-Computer Assisted, Standard Care, and Usual Care for dietary treatment of cholesterol, obesity, and hypertension. Standard Care will involve the same amount of time and health counselor exposure as Innovative Care, but will use currently available materials. Usual Care patients will be referred to their usual provider for treatment. After four months and again at one year, we will assess changes in lipids, blood pressure, and weight. Phase Ill will consist of a feasibility study to test the ability of both innovative care modules to reach low literacy adults through county health departments, worksites, and churches. Results of the feasibility assessment will help us refine a dissemination strategy using the state health department as a centralized coordinating agency, and county health departments to implement the interventions at the community level.
