title: Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.
abstract: BACKGROUND
  Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed.
  
  
  OBJECTIVE
  To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk.
  
  
  METHODS
  Randomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years.
  
  
  METHODS
  Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials.
  
  
  METHODS
  Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke).
  
  
  RESULTS
  By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits.
  
  
  CONCLUSIONS
  Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00000611.
authors.affiliation: MedStar Research Institute/Howard University, Washington, DC, USA. barbara.v.howard@medstar.net
authors.forename: Barbara V
authors.initials: BV
authors.lastname: Howard
authors.forename: Linda
authors.initials: L
authors.lastname: Van Horn
authors.forename: Judith
authors.initials: J
authors.lastname: Hsia
authors.forename: JoAnn E
authors.initials: JE
authors.lastname: Manson
authors.forename: Marcia L
authors.initials: ML
authors.lastname: Stefanick
authors.forename: Sylvia
authors.initials: S
authors.lastname: Wassertheil-Smoller
authors.forename: Lewis H
authors.initials: LH
authors.lastname: Kuller
authors.forename: Andrea Z
authors.initials: AZ
authors.lastname: LaCroix
authors.forename: Robert D
authors.initials: RD
authors.lastname: Langer
authors.forename: Norman L
authors.initials: NL
authors.lastname: Lasser
authors.forename: Cora E
authors.initials: CE
authors.lastname: Lewis
authors.forename: Marian C
authors.initials: MC
authors.lastname: Limacher
authors.forename: Karen L
authors.initials: KL
authors.lastname: Margolis
authors.forename: W Jerry
authors.initials: WJ
authors.lastname: Mysiw
authors.forename: Judith K
authors.initials: JK
authors.lastname: Ockene
authors.forename: Linda M
authors.initials: LM
authors.lastname: Parker
authors.forename: Michael G
authors.initials: MG
authors.lastname: Perri
authors.forename: Lawrence
authors.initials: L
authors.lastname: Phillips
authors.forename: Ross L
authors.initials: RL
authors.lastname: Prentice
authors.forename: John
authors.initials: J
authors.lastname: Robbins
authors.forename: Jacques E
authors.initials: JE
authors.lastname: Rossouw
authors.forename: Gloria E
authors.initials: GE
authors.lastname: Sarto
authors.forename: Irwin J
authors.initials: IJ
authors.lastname: Schatz
authors.forename: Linda G
authors.initials: LG
authors.lastname: Snetselaar
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Stevens
authors.forename: Lesley F
authors.initials: LF
authors.lastname: Tinker
authors.forename: Maurizio
authors.initials: M
authors.lastname: Trevisan
authors.forename: Mara Z
authors.initials: MZ
authors.lastname: Vitolins
authors.forename: Garnet L
authors.initials: GL
authors.lastname: Anderson
authors.forename: Annlouise R
authors.initials: AR
authors.lastname: Assaf
authors.forename: Tamsen
authors.initials: T
authors.lastname: Bassford
authors.forename: Shirley A A
authors.initials: SA
authors.lastname: Beresford
authors.forename: Henry R
authors.initials: HR
authors.lastname: Black
authors.forename: Robert L
authors.initials: RL
authors.lastname: Brunner
authors.forename: Robert G
authors.initials: RG
authors.lastname: Brzyski
authors.forename: Bette
authors.initials: B
authors.lastname: Caan
authors.forename: Rowan T
authors.initials: RT
authors.lastname: Chlebowski
authors.forename: Margery
authors.initials: M
authors.lastname: Gass
authors.forename: Iris
authors.initials: I
authors.lastname: Granek
authors.forename: Philip
authors.initials: P
authors.lastname: Greenland
authors.forename: Jennifer
authors.initials: J
authors.lastname: Hays
authors.forename: David
authors.initials: D
authors.lastname: Heber
authors.forename: Gerardo
authors.initials: G
authors.lastname: Heiss
authors.forename: Susan L
authors.initials: SL
authors.lastname: Hendrix
authors.forename: F Allan
authors.initials: FA
authors.lastname: Hubbell
authors.forename: Karen C
authors.initials: KC
authors.lastname: Johnson
authors.forename: Jane Morley
authors.initials: JM
authors.lastname: Kotchen
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control; D003327:Coronary Disease / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D018752:Diet, Fat-Restricted; D002149:Energy Intake; D005227:Fatty Acids / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D017698:Postmenopause; D011322:Primary Prevention; D016016:Proportional Hazards Models; D012306:Risk; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*
chemical_list: D005227:Fatty Acids