Low Literacy CVD Diet Education for Blacks

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

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:

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1991

Study Completion (Actual)

May 1, 1996

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

May 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4934
  • R01HL046778 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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