Women's Health Trial: Feasibility Study in Minority Populations
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|ClinicalTrials.gov Identifier: NCT00000481|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : February 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Postmenopause||Behavioral: diet, fat-restricted||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||September 1991|
|Study Completion Date :||January 1996|
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
|OverallOfficial:||Valerie George||University of Miami|
|OverallOfficial:||W. Hall||Emory University|
|OverallOfficial:||Albert Oberman||University of Alabama at Birmingham|