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Women's Healthy Eating and Living (WHEL) Study

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Women's Healthy Eating and Living (WHEL) Study

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Pierce, John P.; Faerber, Susan; Wright, Fred A.; Rock, Cheryl L.; Newman, Vicky; Flatt, Shirley W.; Kealey, Sheila; Jones, Vicky E.; Caan, Bette J.; Gold, Ellen B.; Haan, Mary; Hollenbach, Kathryn A.; Jones, Lovell A.; Marshall, James R.; Ritenbaugh, Cheryl; Stefanick, Marcia L.; Thomson, Cynthia; Wasserman, Linda; Natarajan, Loki; Thomas, Ronald G.; Gilpin, Elizabeth; Parker, Barbara A.; Greenberg, E. Robert; Al-Delaimy, Wael K.; Bardwell, Wayne A.; Carlson, Robert W.; Emond, Jennifer A.; Hajek, Richard A.; Karanja, Njeri; Madlensky, Lisa (2016). Women's Healthy Eating and Living (WHEL) Study. UC San Diego Library Digital Collections.


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).

Date Collected
  • 1995 to 2006
Date Issued
  • 2016
Principal Investigator

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.



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  • English
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    Primary associated publication

    • 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. Controlled Clinical Trials 2002;23:728-756.
    • Pierce JP, Natarajan L, Caan BJ, et al. Influence of a Diet Very High in Vegetables, Fruit, and Fiber and Low in Fat on Prognosis Following Treatment for Breast Cancer: The Women's Healthy Eating and Living (WHEL) Randomized Trial. JAMA. 2007;298(3):289–298.
    • Pierce JP, Natarajan L, Caan BJ, Parker BA, Greenberg ER, Flatt SW, Rock CL, Kealey S, Al-Delaimy WK, Bardwell WA, Carlson RW, 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. Influence of a diet very high in vegetables, fruit, and fiber and low in fat on prognosis following treatment for breast cancer: the Women's Healthy Eating and Living (WHEL) randomized trial. JAMA. 2007 Jul 18;298(3):289-98. doi: 10.1001/jama.298.3.289. PMID: 17635889.