Trial Information

BACKGROUND:

The Request for Proposal for the Women's Health Trial: Feasibility Study in Minority
Populations was developed and released by the National Cancer Institute with assistance from
the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

Randomized. Recruitment began in August 1992 and ended in February 1994. Forty percent of
the subjects were randomized to a control group and 60 percent to the dietary intervention
group. Dietary counseling aimed to reduce total fat to 20 percent of calories, reduce
saturated fat and dietary cholesterol intakes, and to increase the intake of fruits,
vegetables, and grain products. Recruitment and randomization were conducted over an
18-month period at three clinical centers. Other objectives of the trial included:
development and evaluation of strategies for recruiting and retaining women of different
racial and SES groups into a dietary intervention study; identification of factors affecting
compliance; assessment of the effects of a modified fat eating pattern on cardiovascular
disease risk factors, including fasting blood lipids and lipoproteins, glucose and insulin,
body weight and blood pressure; identification and assessment of potential biochemical
and/or biological markers for dietary adherence.

Close-out visits began in May 1994 and ended in September 1994. These visits included six,
twelve, and eighteen-month follow-up. NCI extended the coordinating center contract through
January 1996 to support data analysis and publication of research results.