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临床试验/NCT00005727
NCT00005727已完成不适用

CVD Nutrition Education

Stanford University0 个研究点目标入组 351 人开始时间: 1991年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
351

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 100 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen P. Fortmann

C.F. Rehnborg Professor in Disease Prevention, Emeritus

Stanford University

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