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The Women's Health Initiative Dietary Modification Trial

Barbara V. Howard, PhD; JoAnn E. Manson, MD, DrPH; Marcia L. Stefanick, PhD; Shirley A. Beresford, PhD; Gail Frank, DrPH; Bobette Jones, DrPH; Rebecca J. Rodabough, MS; Linda Snetselaar, PhD; Cynthia Thomson, PhD; Lesley Tinker, PhD; Mara Vitolins, DrPH; Ross Prentice, PhD

JAMA. 2006;295:39-49.

Context  Obesity in the United States has increased dramatically during the past several decades. There is debate about optimum calorie balance for prevention of weight gain, and proponents of some low-carbohydrate diet regimens have suggested that the increasing obesity may be attributed, in part, to low-fat, high-carbohydrate diets.

Objectives  To report data on body weight in a long-term, low-fat diet trial for which the primary end points were breast and colorectal cancer and to examine the relationships between weight changes and changes in dietary components.

Design, Setting, and Participants  Randomized intervention trial of 48 835 postmenopausal women in the United States who were of diverse backgrounds and ethnicities and participated in the Women's Health Initiative Dietary Modification Trial; 40% (19 541) were randomized to the intervention and 60% (29 294) to a control group. Study enrollment was between 1993 and 1998, and this analysis includes a mean follow-up of 7.5 years (through August 31, 2004).

Interventions  The intervention included group and individual sessions to promote a decrease in fat intake and increases in vegetable, fruit, and grain consumption and did not include weight loss or caloric restriction goals. The control group received diet-related education materials.

Main Outcome Measure  Change in body weight from baseline to follow-up.

Results  Women in the intervention group lost weight in the first year (mean of 2.2 kg, P<.001) and maintained lower weight than control women during an average 7.5 years of follow-up (difference, 1.9 kg, P<.001 at 1 year and 0.4 kg, P = .01 at 7.5 years). No tendency toward weight gain was observed in intervention group women overall or when stratified by age, ethnicity, or body mass index. Weight loss was greatest among women in either group who decreased their percentage of energy from fat. A similar but lesser trend was observed with increases in vegetable and fruit servings, and a nonsignificant trend toward weight loss occurred with increasing intake of fiber.

Conclusion  A low-fat eating pattern does not result in weight gain in postmenopausal women.

Clinical Trial Registration  ClinicalTrials.gov Identifier: NCT00000611

Author Affiliations: MedStar Research Institute, Washington, DC (Dr Howard); Brigham and Women's Hospital, Harvard Medical School, Boston, Mass (Dr Manson); Stanford School of Medicine, Stanford, Calif (Dr Stefanick); Fred Hutchinson Cancer Research Center, Seattle, Wash (Drs Beresford, Tinker, and Prentice and Ms Rodabough); University of California at Irvine, Orange (Dr Frank); University of North Carolina School of Medicine and Public Health, Durham (Dr Jones); University of Iowa, Iowa City (Dr Snetselaar); University of Arizona, Department of Nutritional Sciences and Arizona Cancer Center, Tucson (Dr Thomson); and Wake Forest University School of Medicine, Winston-Salem, NC (Dr Vitolins).

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Low-Fat Diet and Weight Change in Postmenopausal Women
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Barbara V. Howard, JoAnn E. Manson, Marcia L. Stefanick, Shirley A. Beresford, Gail Frank, Bobette Jones, Rebecca J. Rodabough, Linda Snetselaar, Cynthia Thomson, Lesley Tinker, Mara Vitolins, and Ross Prentice
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