The Women's Healthy Eating & Living (WHEL) Study was an NIH-supported clinical trial. In compliance with the terms and conditions of NIH's Data Sharing Policy as well as to promote the concept of data sharing, these data are being made publicly available. Also in accordance with NIH policy, the datasets include only de-identified data and documentation. All personally identifiable health information such as dates or study sites has been removed in accordance with the HIPAA privacy rule.
The Women's Healthy Eating and Living (WHEL) Study was a multisite randomized controlled trial of the effectiveness of a high-vegetable, low-fat diet, aimed at markedly raising circulating carotenoid concentrations from food sources, in reducing additional breast cancer events and early death in women with early-stage invasive breast cancer (within 4 years of diagnosis). 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.
Senior Statistician/Data Management Coordinator
UCSD Moores Cancer Center
Phone: (858) 822-6830
Fax: (858) 822-6896
For questions about data file access:
Interim Data Services Librarian
Social Sciences & Humanities Library
University of California, San Diego
Phone: (858) 822-1993
Fax: (858) 534-7548
WHEL Bibliography (.doc)
Pierce JP, Faerber S, Wright FA, Rock CL, Newman V, Flatt SW, Kealey S, Jones VE, Caan BJ, Gold EB, Haan M, Hollenbach KA, Jones L, Marshall JR, Ritenbaugh C, Stefanick ML, Thomson C, Wasserman L, Natarajan L, Gilpin EA, Thomas RG, for the WHEL Study Group. A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: Women’s Healthy Eating and Living (WHEL) Study. Control Clin Trials 2002;23:728-756. PUB MED
Pierce JP, Natarajan L, Caan BJ, Parker BA, Greenberg ER, Flatt SW, Rock CL, Kealey S, Al-Delaimy WK, Bardwell WA, Carlson R, Emond JA, Faerber S, Gold EB, Hajek RA, Hollenbach K, Jones LA, Karanja N, Madlensky L, Marshall J, Newman VA, Ritenbaugh C, Thomson CA, Wasserman L, Stefanick ML. The influence of a very high vegetable-fruit-fiber, low-fat diet on prognosis following treatment for breast cancer. The Women’s Healthy Eating and Living (WHEL) randomized trial. The Women’s Healthy Eating and Living (WHEL) randomized trial. JAMA 2007;298:289-298. PUB MED PMCID: PMC2083253