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Women's Health Trial: Feasibility Study in Minority Populations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000481
First Posted: October 28, 1999
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
To evaluate the feasibility of recruiting women of different socioeconomic status and minority groups and to determine whether these women could achieve and maintain a modified fat-eating pattern. The full-scale trial sought to determine whether a low-fat diet could decrease the incidence of cancer and coronary heart disease in postmenopausal women. The National Heart, Lung, and Blood Institute contributed funds over a three-year period to measure lipids, lipoproteins, and other cardiovascular disease risk factors.

Condition Intervention Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause Behavioral: diet, fat-restricted Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1991
Estimated Study Completion Date: January 1996
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000481


Sponsors and Collaborators
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Valerie George University of Miami
OverallOfficial: W. Hall Emory University
OverallOfficial: Albert Oberman University of Alabama at Birmingham
  More Information

Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00000481     History of Changes
Other Study ID Numbers: 71
N01CN025427-010 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases