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Phase 3
50 Years
69 Years
Not Enrolling
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Postmenopause

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Trial Information


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.


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.

Inclusion Criteria

Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total
calories as fat at baseline.

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Valerie George

Investigator Affiliation:

University of Miami


United States: Federal Government

Study ID:




Start Date:

September 1991

Completion Date:

January 1996

Related Keywords:

  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Myocardial Ischemia
  • Postmenopause
  • Cardiovascular Diseases
  • Myocardial Ischemia
  • Coronary Artery Disease
  • Coronary Disease
  • Heart Diseases
  • Ischemia