CVD Nutrition Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005727
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : August 24, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen P. Fortmann, Stanford University

Brief Summary:
To conduct a randomized, controlled trial of cardiovascular disease nutrition education using a cluster design with two conditions, special intervention (SI) and usual care (UC).

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Behavioral: Intervention Not Applicable

Detailed Description:


Progress in educating those with low literacy levels about CVD risk factors related to nutrition had been hampered by the lack of appropriate materials and programs. It was questionable whether the traditional methods of education used with literate, middle-income populations were generalizable to low literate, lower-income populations. While past work had demonstrated significant associations between dietary practices and risk for CVD--in the form of hypercholesterolemia, obesity, and hypertension--as well as alterations in risk when dietary practices were changed, effective educational methods for low literate populations who were at high risk for CVD were still in their infancy in 1991.

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 two clusters were comprised of small groups of multi-ethnic, low-income individuals who were predominantly women aged 20-35 with low-literacy levels. The source of these groups was the Expanded Food and Nutrition Education Program (EFNEP), a program of the USDA and Cooperative Extension Services of the University of California. EFNEP provided basic, non-CVD specific nutrition information to approximately 1000 low-income families in Santa Clara County, California annually in conjunction with job training programs and specialty schools for low-literate individuals. Twenty-four groups were matched in pairs for group size and type of setting and one of each pair was allocated randomly to receive the UC or SI. The UC group received an eight one-hour classroom curriculum covering nutrition information on the basic food groups, meal planning and food purchasing, delivered primarily through lecture and print materials. The Sl involved designing an innovative CVD nutrition program, composed of distinct education modules, that used face-to-face, participatory education and mediated materials for low-literate adults. Participants learned to modify their own family menus, select and prepare low cost foods obtained from the USDA or food stamps, and received specially adapted and newly developed materials that relied little on written communication that were sensitive to cultural dietary beliefs.

Summative evaluation involved testing whether the SI groups had a greater change in CVD nutrition knowledge and behavior (as measured by self-report) 24 hour diet recalls, and serum cholesterol) from baseline to an eight week post-test, and through a five month maintenance period. The generalization phase of the research tested a revised version of the program in a non-classroom setting with Head Start families, and intervened at the community level to modify the food selection and preparation practices of organizations (such as soup kitchens, food banks, and homeless shelters) that provide food to low-income/low-literate groups. As the concluding aspect of the study, the feasibility was explored of disseminating the nutrition program and education modules to local and national groups serving low-literate populations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 1991
Actual Primary Completion Date : December 1995
Actual Study Completion Date : January 2000

Arm Intervention/treatment
Experimental: Intervention
Specially-designed nutrition education curriculum designed to lower dietary fat intake in people with low literacy skills.
Behavioral: Intervention
Classroom-based nutrition education curriculum designed for individuals with low literacy skills.

Active Comparator: Control
General nutrition education curriculum.
Behavioral: Intervention
Classroom-based nutrition education curriculum designed for individuals with low literacy skills.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria

Responsible Party: Stephen P. Fortmann, C.F. Rehnborg Professor in Disease Prevention, Emeritus, Stanford University Identifier: NCT00005727     History of Changes
Other Study ID Numbers: 4936
R01HL046782 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stephen P. Fortmann, Stanford University:

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases