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CVD Nutrition Modules Tailored to Low Literacy Skills

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00005724
First received: May 25, 2000
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills.

Condition Intervention
Cardiovascular Diseases Heart Diseases Behavioral: Computer Program Intervention Group Other: Minimal Intervention Group Behavioral: Health Counselor Intervention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: CVD Nutrition Modules Tailored to Low Literacy Skills

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Primary Outcome Measure [ Time Frame: 3-month follow-up ]
    Total cholesterol


Enrollment: 369
Actual Study Start Date: August 1991
Study Completion Date: July 31, 1996
Primary Completion Date: July 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Must have high cholesterol; Low-literacy skills; Must be patient at one of 9 community health centers recruited for study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005724

Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Thomas Keyserling, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00005724     History of Changes
Other Study ID Numbers: 4933
R01HL046775 ( US NIH Grant/Contract Award Number )
Study First Received: May 25, 2000
Last Updated: April 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on June 23, 2017