Cardiovascular Diseases Clinical Trial
To utilize a community-based approach to nutrition education in an urban African American community.
BACKGROUND:
The investigator originally applied for the grant in response to 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. However, the grant was
not awarded as part of the RFA.
DESIGN NARRATIVE:
The overall goal was to achieve a significant increase in the proportion of African
Americans consuming a low fat, low salt "prudent" diet and to increase the proportion with
optimal levels of blood pressure and total blood cholesterol. The specific aims were to: 1)
assess the eating patterns and attendant nutrition literacy issues in urban African
Americans, 2) determine the effectiveness of a lay volunteer-mediated multimodal
culturally-specific church-based intervention compared with a strategy using solely written
and visual self-help materials, 3) determine the impact of an intensive culturally-specific
nutrition education intervention on the selection of "prudent" low fat, low salt
alternatives when compared with the usual approaches to influencing food selection in major
markets and fast-food restaurants, and 4) develop a process module which allowed
generalization of this community-based technique to other low literacy high
cultural-specificity groups.
The study had three phases and utilized a social-marketing approach. Phase I, the first year
of the study, was a community diagnosis consisting of a population-based
random-digit-dialing survey and a series of focus groups to define eating patterns and
nutrient intake in their social context in the African American population. Community focus
groups were conducted to design culturally-specific nutrition education modules to be used
in two subsequent randomized trials. Phase I also consisted of the adaptation of existing
instruments to determine nutrition literacy levels, comprehension and the readability
specifically in this population.
Phase II, in years two, three and the first six months of year four of the study, was
comprised of a randomized trial of a nutrition education module administered through trained
lay nutrition counselors in East Baltimore churches compared with churches which received
only self-help materials designed for the literacy level. Outcomes included assessment of
total calories from fat, from saturated fat, cholesterol in mg/day and blood pressure and
blood cholesterol levels measured one, six and 12 months after the intervention.
Phase III, conducted in year four, consisted of a randomized trial of an intensive nutrition
intervention which was designed for the culture and was compared with usual advertising and
food-selection influence techniques in eight fast food restaurants and four large food
markets in East Baltimore. Outcomes included the shift in sales from high to low fat and
salt alternatives (as determined by computerized sales and inventory data) during the
intervention and two weeks following the intervention. All interventions in Phase II and III
evolved from the focus groups and survey work performed in Phase I.
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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