CVD Nutrition Modules Tailored to Low Literacy Skills
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|ClinicalTrials.gov Identifier: NCT00005724|
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases||Behavioral: Computer Program Intervention Group Other: Minimal Intervention Group Behavioral: Health Counselor Intervention Group||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||369 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CVD Nutrition Modules Tailored to Low Literacy Skills|
|Actual Study Start Date :||August 1991|
|Actual Primary Completion Date :||July 1995|
|Actual Study Completion Date :||July 31, 1996|
Minimal Intervention Group
Pamphlets on healthy eating mailed to participants.
Other: Minimal Intervention Group
Dietary Information pamphlets.
Experimental: Health Counselor Intervention Group
Food for Heart program, a structured diet treatment program for low-income patients with high cholesterol, given by health counselor at 4 treatment visits.
Behavioral: Health Counselor Intervention Group
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.
Experimental: Computer Program Intervention Group
User-friendly interactive computer program providing dietary counseling tailored to the needs of the participant.
Behavioral: Computer Program Intervention Group
A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.
- Primary Outcome Measure [ Time Frame: 3-month follow-up ]Total cholesterol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005724
|Principal Investigator:||Thomas Keyserling, MD||University of North Carolina, Chapel Hill|