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OpenTrials
Completed

NCT Number: NCT00005724

CVD Nutrition Modules Tailored to Low Literacy Skills

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

Completed

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Must have high cholesterol; Low-literacy skills; Must be patient at one of 9 community health centers recruited for study

Treatment and study plan

Computer Program Intervention Group

Behavioral

A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.

Minimal Intervention Group

Other

Dietary Information pamphlets.

Health Counselor Intervention Group

Behavioral

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.

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 3-month follow-up

    Total cholesterol

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
1991
Primary completion
1995
Study completion
1996
First posted
May 26, 2000
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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