The women's health initiative dietary modification trial: overview and baseline characteristics of participants (2022)

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Article preview Annals of Epidemiology Introduction Section snippets Screening and eligibility for the dietary modification trial Results Comparisons of key variables to national data First page preview References (42) Ann Epidemiol J Am Diet Assoc J Am Diet Assoc J Am Diet Assoc J Am Diet Assoc Prev Med Am J Cardiol Meta-analysis of animal experiments: elucidating relationships between dietary fat and mammary tumor development in rodents Adv Exp Med Biol Quantitative review of studies of dietary fat and rat colon carcinoma Nutr Cancer Dietary fat and cancer: consistency of the epidemiologic data, and disease prevention that may follow from a practical reduction in fat consumption Cancer Causes Control Seven Countries: A multivariate analysis of death and coronary heart disease Migration patterns and breast cancer risk in Asian-American women J Natl Cancer Inst Cancer in migrants to Australia: extending the descriptive epidemiological data Cancer Res Dietary factors and risk of breast cancer: combined analysis of 12 case-control studies J Natl Cancer Inst Association of dietary intake of fat and fatty acids with risk of breast cancer JAMA Cohort studies of fat intake and the risk of breast cancer–a pooled analysis N Engl J Med Dietary fat and fiber in relation to risk of breast cancer JAMA Fat and fiber and breast cancer research-where is the field going? Breast Cancer Res The Women's Health Initiative: Overview of the Nutrition Components Results of a randomized feasibility study of a low-fat diet Arch Intern Med The Women's Health Trial Feasibility Study in Minority Populations: Design and baseline descriptions Ann Epidemiol Cited by (166) Accuracy of self-reported weight in the Women's Health Initiative Practical considerations for sandwich variance estimation in two-stage regression settings Role of dietary patterns and acculturation in cancer risk and mortality among postmenopausal Hispanic women: results from the Women’s Health Initiative (WHI) Social Isolation and Incident Heart Failure Hospitalization in Older Women: Women’s Health Initiative Study Findings Recommended articles (6) Videos
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Annals of Epidemiology

Volume 13, Issue 9, Supplement,

October 2003

, Pages S87-S97

Author links open overlay panelCherylRitenbaughPhD, MPHRuth EPattersonPhD, RDPersonEnvelopeRowan TChlebowskiMD, PhDBetteCaanDrPHLesleyFels-TinkerPhD, RDBarbaraHowardPhDJudyOckenePhD

Introduction

The Dietary Modification (DM) component of the Women's Health Initiative (WHI) is a randomized controlled evaluation of a low-fat diet that is high in fruits, vegetables, and grains. This low-fat dietary pattern is hypothesized to reduce the risk of breast and colorectal cancer and secondarily, coronary heart disease, in postmenopausal women. To test these hypotheses, 48,836 postmenopausal women were randomly assigned to either the low-fat eating pattern (40%) or self-selected dietary behavior (60%). The nutrition goals for women in the intervention arm are to reduce energy from fat to 20% and energy from saturated fat to 7%, and to increase fruit and vegetable intake to at least five servings per day and grains to at least six servings per day. Participants will be followed for an average of 8.5 years.

The DM was motivated by animal studies 1., 2., international ecologic studies of diet and disease 3., 4., migrant studies 5., 6., 7., and epidemiologic studies (8) indicating that the diet, particularly lower levels of fat intake, has the potential to reduce risk of breast cancer, colon cancer, and heart disease. Within-country analytic epidemiologic studies of fat and breast and colorectal cancers have yielded inconsistent or null results 9., 10., 11.. However there are substantial obstacles to finding clear and interpretable relationships in these studies (12):

(Video) Low-fat Diet: Not Significant for Breast Cancer Prevention

Current or recent fat intakes may differ from intakes during the years pertinent to the development of chronic diseases, likely attenuating associations.

Fat intakes in Western populations may not be highly variable, in spite of the variety of foods available.

It is difficult to estimate the relationship between fat intake and disease because diet is a complex mixture of foods, nutrients, and other bioactive compounds.

Dietary patterns often relate to other disease risk factors, offering the potential for confounding (or over-control) in these studies.

Considerable random, systematic, and person-specific errors exist in all available dietary assessment methods and the key measurement properties of these instruments are not well understood.

The purpose of this report is to describe the baseline characteristics of participants in the DM trial, with emphasis on sociodemographics, health behavior, medical history, dietary intake, and other factors that could relate to the clinical outcomes.

Section snippets

Screening and eligibility for the dietary modification trial

The WHI included postmenopausal women aged 50 to 79 years. Women with previous or existing breast cancer or invasive cancer of any type within the past 10 years were excluded. General WHI trial eligibility criteria are provided in Hays' article in this issue. The DM component also excluded women who were: 1) on a low-fat diet (<32% energy from fat); 2) had dietary needs incompatible with the intervention program (e.g. celiac sprue); 3) ate 10 or more meals per week outside the home; 4) could

Results

Similar to the presentation of results for the other components, the baseline description of participants in the Dietary Modification trial is stratified by age. Because there was a study-wide emphasis on inclusion of minorities, all demographic, medical history, dietary intake and blood analytes are given by race/ethnicity group in the Appendix to Hays' article. Differences by age and race/ethnicity are generally statistically significant because of the large sample sizes. Therefore, we simply

Comparisons of key variables to national data

Since DM participants were not recruited as a representative sample from the US population, it is instructive to compare this sample to US women aged 50 to 79 years. Compared with women from the NHANES III, DM participants are more obese. Specifically, in the three age decades, 73%, 76%, and 73% of DM participants have BMI greater than 25 as compared with 64%, 64%, and 58% of NHANES III women (19). In contrast, DM participants have lower rates of hypertension: 28%, 38%, and 45% compared with

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