The Women's Health Trial Feasibility Study in Minority Populations: Design and baseline descriptions

• Published in: Annals of epidemiology 1996-11, Vol.6 (6), p.507-519
• Main Authors: Bowen, Deborah, Clifford, Carolyn K., Coates, Ralph, Evans, Marguerite, Feng, Ziding, Fouad, Mona, George, Valerie, Gerace, Terence, Grizzle, James E., Hall, W.Dallas, Hearn, Marsha, Henderson, Maureen, Kestin, Mark, Kristal, Alan, Leary, Elizabeth Teng, Lewis, Cora E., Oberman, Albert, Prentice, Ross, Raczynski, James, Toivola, Bert, Urban, Nicole
• Format: Article
• Language: English
• Subjects: Aged; Analysis of Variance; cholesterol; Cholesterol, Dietary - adverse effects; clinical trial; dietary fat; Dietary Fats - adverse effects; Feasibility Studies; Female; Humans; intervention; Middle Aged; minorities; Minority Groups; Patient Compliance; Patient Selection; Randomized Controlled Trials as Topic; Reproducibility of Results; Research Design; Risk Factors; Socioeconomic Factors; weight; Women's Health
• ISSN: 1047-2797; 1873-2585
• DOI: 10.1016/S1047-2797(96)00072-5

The Women's Health Trial: Feasibility Study in Minority Populations (WHT:FSMP), a randomized trial of 2208 women, was conducted to investigate three questions. First, can women from minority and low-socioeconomic-status populations be recruited in numbers sufficient to evaluate a dietary intervention designed to lower fat intake. Second, the efficacy of a low fat, increased fruit/vegetable/ grain product intervention for reducing fat consumption. Third, will participation in the intervention lower plasma cholesterol and estradiol levels relative to the controls. The baseline results showed that an adequate number of minority and low SES women could be recruited to test the study hypotheses. A diverse study population of postmenopausal women consuming a high fat diet was recruited: 28% of participants were Black, 16% were Hispanic, 11% had less than a high school level of education, and 15.5% had household incomes of < $15,000.