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The Women's Health Initiative Randomized Controlled Dietary Modification Trial

Lesley F. Tinker, PhD; Denise E. Bonds, MD, MPH; Karen L. Margolis, MD, MPH; JoAnn E. Manson, MD, DrPH; Barbara V. Howard, PhD; Joseph Larson, MS; Michael G. Perri, PhD; Shirley A. A. Beresford, PhD; Jennifer G. Robinson, MD, MPH; Beatriz Rodríguez, MD, PhD; Monika M. Safford, MD; Nanette K. Wenger, MD; Victor J. Stevens, PhD; Linda M. Parker, DSc

Arch Intern Med. 2008;168(14):1500-1511.

Background  Decreased fat intake with weight loss and increased exercise may reduce the risk of diabetes mellitus in persons with impaired glucose tolerance. This study was undertaken to assess the effects of a low-fat dietary pattern on incidence of treated diabetes among generally healthy postmenopausal women.

Methods  A randomized controlled trial was conducted at 40 US clinical centers from 1993 to 2005, including 48 835 postmenopausal women aged 50 to 79 years. Women were randomly assigned to a usual-diet comparison group (n = 29 294 [60.0%]) or an intervention group with a 20% low-fat dietary pattern with increased vegetables, fruits, and grains (n = 19 541 [40.0%]). Self-reported incident diabetes treated with oral agents or insulin was assessed.

Results  Incident treated diabetes was reported by 1303 intervention participants (7.1%) and 2039 comparison participants (7.4%) (hazard ratio, 0.96; 95% confidence interval, 0.90-1.03; P = .25). Weight loss occurred in the intervention group, with a difference between intervention and comparison groups of 1.9 kg after 7.5 years (P < .001). Subgroup analysis suggested that greater decreases in percentage of energy from total fat reduced diabetes risk (P for trend = .04), which was not statistically significant after adjusting for weight loss.

Conclusions  A low-fat dietary pattern among generally healthy postmenopausal women showed no evidence of reducing diabetes risk after 8.1 years. Trends toward reduced incidence were greater with greater decreases in total fat intake and weight loss. Weight loss, rather than macronutrient composition, may be the dominant predictor of reduced risk of diabetes.

Trial Registration  clinicaltrials.gov Identifier: NCT00000611

Author Affiliations: Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington (Dr Tinker and Mr Larson); Division of Public Health Sciences and Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina (Dr Bonds); Department of Medicine, University of Minnesota, Minneapolis (Dr Margolis); Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (Dr Manson); Department of Field Studies, MedStar Research Institute, Washington, DC (Dr Howard); Department of Clinical and Health Psychology, University of Florida, Gainesville (Dr Perri); Department of Epidemiology, University of Washington, Seattle (Dr Beresford); Departments of Epidemiology and Medicine, University of Iowa, Iowa City (Dr Robinson); Department of Geriatric Medicine, University of Hawaii, Honolulu (Dr Rodríguez); Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center (Dr Safford); Department of Medicine, Emory University School of Medicine, Atlanta, Georgia (Dr Wenger); Science Programs Department, Kaiser Permanente Center for Health Research, Portland, Oregon (Dr Stevens); and School of Nursing and Health Sciences, University of Miami, Miami, Florida (Dr Parker). Dr Bonds is now with the Departments of Public Health Sciences and Medicine, University of Virginia, Charlottesville; Dr Margolis is now with HealthPartners Research Foundation, Minneapolis.

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