Cardiovascular Diseases Clinical Trial
To develop and evaluate a nutrition education program to reduce cardiovascular disease risk in persons with low literacy skills.
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.
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