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CVD Nutrition Education

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen P. Fortmann, Stanford University
ClinicalTrials.gov Identifier:
NCT00005727
First received: May 25, 2000
Last updated: August 23, 2016
Last verified: August 2016
  Purpose
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 Intervention
Cardiovascular Diseases
Heart Diseases
Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by Stanford University:

Enrollment: 351
Study Start Date: August 1991
Study Completion Date: January 2000
Primary Completion Date: December 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  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.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Stephen P. Fortmann, C.F. Rehnborg Professor in Disease Prevention, Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00005727     History of Changes
Other Study ID Numbers: 4936  R01HL046782 
Study First Received: May 25, 2000
Last Updated: August 23, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stanford University:
Nutrition
Education

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 23, 2016