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Low-Fat Dietary Pattern and Risk of Colorectal Cancer
The Women's Health Initiative Randomized Controlled Dietary Modification Trial
Shirley A. A. Beresford, PhD;
Karen C. Johnson, MD;
Cheryl Ritenbaugh, PhD;
Norman L. Lasser, MD;
Linda G. Snetselaar, PhD;
Henry R. Black, MD;
Garnet L. Anderson, PhD;
Annlouise R. Assaf, PhD;
Tamsen Bassford, MD;
Deborah Bowen, PhD;
Robert L. Brunner, PhD;
Robert G. Brzyski, MD;
Bette Caan, DrPH;
Rowan T. Chlebowski, MD;
Margery Gass, MD;
Rosanne C. Harrigan, EdD;
Jennifer Hays, PhD;
David Heber, MD;
Gerardo Heiss, MD;
Susan L. Hendrix, DO;
Barbara V. Howard, PhD;
Judith Hsia, MD;
F. Allan Hubbell, MD;
Rebecca D. Jackson, MD;
Jane Morley Kotchen, MD;
Lewis H. Kuller, MD;
Andrea Z. LaCroix, PhD;
Dorothy S. Lane, MD;
Robert D. Langer, MD;
Cora E. Lewis, MD;
JoAnn E. Manson, MD;
Karen L. Margolis, MD;
Yasmin Mossavar-Rahmani, PhD;
Judith K. Ockene, PhD;
Linda M. Parker, DSc;
Michael G. Perri, PhD;
Lawrence Phillips, MD;
Ross L. Prentice, PhD;
John Robbins, MD;
Jacques E. Rossouw, MD;
Gloria E. Sarto, MD;
Marcia L. Stefanick, PhD;
Linda Van Horn, PhD;
Mara Z. Vitolins, DrPH;
Jean Wactawski-Wende, PhD;
Robert B. Wallace, MD;
Evelyn Whitlock, MD
JAMA. 2006;295:643-654.
Context Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial.
Objective To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women.
Design, Setting, and Participants The Women’s Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48 835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States.
Interventions Participants were randomly assigned to the dietary modification intervention (n = 19 541; 40%) or the comparison group (n = 29 294; 60%).The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern.
Main Outcome Measure Invasive colorectal cancer incidence.
Results A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention.
Conclusion In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up.
Clinical Trials Registration ClinicalTrials.gov Identifier: NCT00000611
Author Affiliations: University of Washington, Seattle (Dr Beresford); University of Tennessee Health Science Center, Memphis (Dr Johnson); University of Arizona, Tucson/Phoenix (Drs Ritenbaugh and Bassford); University of Medicine and Dentistry of New Jersey, Newark (Dr Lasser); University of Iowa, Iowa City/Davenport (Drs Snetselaar and Wallace); Rush University Medical Center, Chicago, Ill (Dr Black); Fred Hutchinson Cancer Research Center, Seattle, Wash (Drs Anderson, Bowen, LaCroix, and Prentice); Brown University, Providence, RI (Dr Assaf); University of Nevada, Reno (Dr Brunner); University of Texas Health Science Center, San Antonio (Dr Brzyski); Kaiser Permanente Division of Research, Oakland, Calif (Dr Caan); Harbor-UCLA Research and Education Institute, Torrance, Calif (Dr Chlebowski); University of Cincinnati, Cincinnati, Ohio (Dr Gass); University of Hawaii, Honolulu (Dr Harrigan); Baylor College of Medicine, Houston, Tex (Dr Hays); University of California at Los Angeles (Dr Heber); University of North Carolina, Chapel Hill (Dr Heiss); Wayne State University School of Medicine/Hutzel Hospital, Detroit, Mich (Dr Hendrix); MedStar Research Institute/Howard University, Washington, DC (Dr Howard); George Washington University, Washington, DC (Dr Hsia); University of California, Irvine (Dr Hubbell); Ohio State University, Columbus (Dr Jackson); Medical College of Wisconsin, Milwaukee (Dr Kotchen); University of Pittsburgh, Pittsburgh, Pa (Dr Kuller); State University of New York at Stony Brook (Dr Lane); University of California at San Diego, La Jolla/Chula Vista (Dr Langer); University of Alabama at Birmingham (Dr Lewis); Brigham and Women's Hospital, Harvard Medical School, Boston, Mass (Dr Manson); University of Minnesota, Minneapolis (Dr Margolis); Albert Einstein College of Medicine, Bronx, NY (Dr Mossavar-Rahmani); University of Massachusetts/Fallon Clinic, Worcester (Dr Ockene); University of Miami, Miami, Fla (Dr Parker); University of Florida, Gainesville/Jacksonville (Dr Perri); Emory University, Atlanta, Ga (Dr Phillips); University of California at Davis, Sacramento (Dr Robbins); National Heart, Lung, and Blood Institute, Bethesda, Md (Dr Rossouw); University of Wisconsin, Madison (Dr Sarto); Stanford Prevention Research Center, Stanford, Calif (Dr Stefanick); Northwestern University, Chicago/Evanston, Ill (Dr Van Horn); Wake Forest University School of Medicine, Winston-Salem, NC (Dr Vitolins); University at Buffalo, Buffalo, NY (Dr Wactawski-Wende); and Kaiser Permanente Center for Health Research, Portland, Ore (Dr Whitlock).
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