CVD Nutrition Modules Tailored to Low Literacy Skills
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      To develop cardiovascular disease nutrition modules tailored to subjects with low literacy
      skills.
    

Detailed description: 
      BACKGROUND:

      The study was part of an NHLBI initiative on "CVD Nutrition Education for Low Literacy
      Skills". The initiative originated within the Prevention and Demonstration Branch of the
      DECA, was approved by the September 1988 National Heart, Lung, and Blood Advisory Council,
      and released in July 1990.

      DESIGN NARRATIVE:

      The study had three phases. The goal of Phase I was to develop two innovative care modules
      that used 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 consisted 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 used 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. The
      investigators used 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 helped further refine the materials.

      In Phase II, a randomized trial was conducted to determine if the innovative modules produced
      a meaningful reduction in cholesterol and overall cardiovascular risk compared to standard
      care. Subjects with high cholesterol and low literacy skills served by four community health
      centers were randomly assigned 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 involved the same amount of time and
      health counselor exposure as Innovative Care, but used currently available materials. Usual
      Care patients were referred to their usual provider for treatment. After four months and
      again at one year, changes in lipids, blood pressure, and weight were assessed..

      Phase Ill consisted 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 helped 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.
    

Intervention name(s): Computer Program Intervention Group; Minimal Intervention Group; Health Counselor Intervention Group
Intervention type(s): Behavioral; Other; Behavioral
Intervention description(s): A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.; Dietary Information pamphlets.; Food for Heart Program - a structured diet treatment program for low income patients with high cholesterol, given by a health counselor at 4 treatment visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention