Low Literacy CVD Diet Education for Blacks

Cardiovascular Diseases Clinical Trial

Status Completed

Clinical Trial Summary

To develop and demonstrate the efficacy of a set of original, cardiovascular (CVD) nutrition education materials designed to reduce intake of sodium (Na) fat, and cholesterol and which would be appropriate for urban Black adults with 5th to 8th grade reading levels.

Clinical Trial 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:

Materials were designed to accomplish the objectives of conventional nutrition education/behavior change programs, but avoiding the usual dependency of traditional programs on strategies that required a high level of reading and arithmetic. Guiding principles were: the need to identify the food related conceptual, cultural, and social frameworks of members of the target audience; and develop a program that built upon already-developed, alternative communication and coping skills. The core of the system was a) a protocol for office-based patient assessment and follow up, b) an educational/motivational videotape viewed in the clinical setting, c) scripts and supporting materials for a 4-week minicourse led by a clinic staff member or volunteer, and d) a package of audiocassettes and supporting printed materials to facilitate self-directed learning over an extended time period. Printed materials emphasized the use of cards (hence the acronym 'CARDES') that delivered single concepts about nutrition or behavior change and that permitted manipulation, selection, and reorganization of information.

CARDES was developed and evaluated in cooperation with Howard University Hospital in Washington, D.C. Using a randomized two-group design and a 12-24 month follow up, serum cholesterol and blood pressure levels of persons counseled with the CARDES program were compared with values for a control group receiving usual care. Process measures described adherence outcomes and determinants. Secondary outcomes related to CVD risk factor status were also evaluated. Prior to the evaluation, a pilot study determined the best sequence for delivering the information related to dietary change (i.e., Na first, fat/cholesterol first, or concurrent). Subsequent to the evaluation and prior to development of the final system and dissemination plan, an assessment was made of the potential utility of CARDES with other black populations with low literacy skills.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. ;

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

• NCT number: NCT00005725
• Study type: Observational
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Status: Completed
• Phase: N/A
• Start date: August 1991
• Completion date: May 1996