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Evaluation of Low Literacy CVD Nutrition Education

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 26, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005726
    Brief Title
    Evaluation of Low Literacy CVD Nutrition Education
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 1995 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To develop and evaluate a nutrition education program to reduce cardiovascular disease risk in persons with low literacy skills.
    Detailed Description
    BACKGROUND: The setting for the study was the Minnesota Extension Service's Expanded Food and Nutrition Education Program (EFNEP), which was a U.S. Department of Agriculture-funded program to improve the nutrition knowledge and behavior of low-income individuals who were responsible for food preparation. The emphasis of EFNEP was on obtaining adequate and nutritious foods, and not on dietary behaviors for the prevention of chronic disease. Because a large proportion of this population had no more than an 8th grade education (30.9 percent nationally), EFNEP provided access to individuals with low literacy skills and a need for nutrition education for disease prevention. For example, a pilot study indicated that 34 of 42 respondents had never had their blood cholesterol level checked. 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 developed education strategies using focus groups of both the Minnesota Extension Service's Expanded Food and Nutrition Education Program (EFNEP) program participants and the EFNEP paraprofessionals who delivered the program. The intent of the focus groups was to identify concerns, interests, barriers, and perceived needs for nutrition education for cardiovascular disease prevention. This information was used to develop effective education strategies that addressed the needs of the study participants, while accomplishing the study goal of effecting dietary change (specifically, decrease in dietary fat and cholesterol intake) for cardiovascular disease risk reduction. The effectiveness of the nutrition education program was evaluated in a randomized trial, with pre- and post-intervention measures of dietary fat intake and plasma total and HDL cholesterol as outcome measures. The study was conducted in Hennepin, Ramsey and Dakota Counties, which had a total adult EFNEP enrollment of about 1,842 people. Because EFNEP enrollment was predominantly female (94 percent), this study was limited to adult women, age 18 or older. All 22 EFNEP paraprofessionals in these counties were randomized to intervention and control group. Randomization was at the level of paraprofessional to simplify program delivery and to minimize contamination between intervention and control groups. The differential changes in fat intake and plasma cholesterol level between the intervention and control groups were estimated using analysis of covariance, adjusting for within paraprofessional correlation and other potential confounders. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9353681
    Citation
    Hartman TJ, McCarthy PR, Park RJ, Schuster E, Kushi LH. Results of a community-based low-literacy nutrition education program. J Community Health. 1997 Oct;22(5):325-41. doi: 10.1023/a:1025123519974.
    Results Reference
    background
    PubMed Identifier
    8021415
    Citation
    Hartman TJ, McCarthy PR, Park RJ, Schuster E, Kushi LH. Focus group responses of potential participants in a nutrition education program for individuals with limited literacy skills. J Am Diet Assoc. 1994 Jul;94(7):744-8. doi: 10.1016/0002-8223(94)91940-2.
    Results Reference
    background

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    Evaluation of Low Literacy CVD Nutrition Education

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