Women's Healthy Eating and Living (WHEL) Study

The study randomly assigned 3088 such women to an intensive diet intervention or to a comparison group between 1995 and 2000 and followed them through 2006. Two thirds of these women were under 55 years of age at randomization. This research study had a coordinating center and seven clinical sites. Randomization was stratified by age, stage of tumor and clinical site. A comprehensive intervention program that included intensive telephone counseling, cooking classes and print materials helped shift the dietary pattern of women in the intervention. Through an innovative telephone counseling program, dietary counselors encouraged women in the intervention group to meet the following daily behavioral targets: five vegetable servings, 16 ounces of vegetable juice, three fruit servings, 30 g of fiber and 15-20% energy from fat. Adherence assessments occurred at baseline, 6, 12, 24 or 36, 48 and 72 months. These assessments can include dietary intake (repeated 24-hour dietary recalls and food frequency questionnaire), circulating carotenoid concentrations, physical measures and questionnaires about health symptoms, quality of life, personal habits and lifestyle patterns. Outcome assessments were completed by telephone interview every 6 months with medical record verification. We assessed evidence of effectiveness by the length of the breast cancer event-free interval, as well as by overall survival separately in all the women in the study as well as specifically in women under and over the age of 55 years.