Women's Health Trial: Feasibility Study in Minority Populations

National Cancer Institute (NCI) logo

National Cancer Institute (NCI)

Status and phase

Completed
Phase 3

Conditions

Myocardial Ischemia
Cardiovascular Diseases
Postmenopause
Heart Diseases
Coronary Disease

Treatments

Behavioral: diet, fat-restricted

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000481
71
N01CN025427-010 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

50 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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