CVD Nutrition Modules Tailored to Low Literacy Skills

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Cardiovascular Diseases
Heart Diseases

Treatments

Other: Minimal Intervention Group
Behavioral: Computer Program Intervention Group
Behavioral: Health Counselor Intervention Group

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00005724
R01HL046775 (U.S. NIH Grant/Contract)
4933

Details and patient eligibility

About

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

Full 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.

Enrollment

369 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

369 participants in 3 patient groups

Minimal Intervention Group
Other group
Description:
Pamphlets on healthy eating mailed to participants.
Treatment:
Other: Minimal Intervention Group
Health Counselor Intervention Group
Experimental group
Description:
Food for Heart program, a structured diet treatment program for low-income patients with high cholesterol, given by health counselor at 4 treatment visits.
Treatment:
Behavioral: Health Counselor Intervention Group
Computer Program Intervention Group
Experimental group
Description:
User-friendly interactive computer program providing dietary counseling tailored to the needs of the participant.
Treatment:
Behavioral: Computer Program Intervention Group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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