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Substudies
phs000227.v5.p3 : PAGE: Women's Health Initiative (WHI)
phs000281.v8.p3 : NHLBI GO-ESP: Women's Health Initiative Exome Sequencing Project (WHI) - WHISP
phs000315.v8.p3 : WHI GARNET
phs000386.v8.p3 : NHLBI WHI SHARe
phs000503.v6.p3 : Women's Health Initiative Sight Examination (WHISE)
phs000675.v4.p3 : WHIMS+ GWAS: GWAS on Selected WHI Hormone Trial European Americans
phs000746.v3.p3 : WHI Harmonized and Imputed GWAS Data
phs001334.v2.p3 : Metabolomics of Coronary Heart Disease (CHD) in the WHI
phs001335.v2.p3 : NHLBI's BA23 in WHI
phs001614.v1.p3 : WHI Long Life Study Phase III GWAS Data

Study Description

The Women's Health Initiative (WHI) is a long-term national health study that has focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. The original WHI study included 161,808 postmenopausal women enrolled between 1993 and 1998. The Fred Hutchinson Cancer Research Center in Seattle, WA serves as the WHI Clinical Coordinating Center for data collection, management, and analysis of the WHI.

The WHI has two major parts: a partial factorial randomized Clinical Trial (CT) and an Observational Study (OS); both were conducted at 40 Clinical Centers nationwide.

The CT enrolled 68,132 postmenopausal women between the ages of 50-79 into trials testing three prevention strategies. If eligible, women could choose to enroll in one, two, or all three of the trial components. The components are:

  • Hormone Therapy Trials (HT): This double-blind component examined the effects of combined hormones or estrogen alone on the prevention of coronary heart disease and osteoporotic fractures, and associated risk for breast cancer. Women participating in this component with an intact uterus were randomized to estrogen plus progestin (conjugated equine estrogens [CEE], 0.625 mg/d plus medroxyprogesterone acetate [MPA] 2.5 mg/d] or a matching placebo. Women with prior hysterectomy were randomized to CEE or placebo. Both trials were stopped early, in July 2002 and March 2004, respectively, based on adverse effects. All HT participants continued to be followed without intervention until close-out.
  • Dietary Modification Trial (DM): The Dietary Modification component evaluated the effect of a low-fat and high fruit, vegetable and grain diet on the prevention of breast and colorectal cancers and coronary heart disease. Study participants were randomized to either their usual eating pattern or a low-fat dietary pattern.
  • Calcium/Vitamin D Trial (CaD): This double-blind component began 1 to 2 years after a woman joined one or both of the other clinical trial components. It evaluated the effect of calcium and vitamin D supplementation on the prevention of osteoporotic fractures and colorectal cancer. Women in this component were randomized to calcium (1000 mg/d) and vitamin D (400 IU/d) supplements or a matching placebo.

The Observational Study (OS) examines the relationship between lifestyle, environmental, medical and molecular risk factors and specific measures of health or disease outcomes. This component involves tracking the medical history and health habits of 93,676 women not participating in the CT. Recruitment for the observational study was completed in 1998 and participants were followed annually for 8 to 12 years.

Extension Studies: The original protocol allowed for follow-up until March 2005, after which participants were invited to enroll in the first WHI Extension Study for follow-up through 2010. Participants were invited again to participate in the second WHI Extension Study with continued follow up from 2010 to at least 2015. As of March 31, 2011 there were 93,122 women enrolled in the second extension.

In Extension Study 2, the overall WHI study population was divided into two new subsamples, the Medical Records Cohort (MRC) and the Self-Report Cohort (SRC). The MRC consists of all former hormone trial participants and all African American and Hispanic participants from all study components. The SRC consists of the remaining participants. The extent of outcome information collected differs between the two cohorts, with more extensive outcomes information collection on the MRC.

As part of Extension Study 2, selected older WHI participants were invited to participate in an In Person Visit (a.k.a., Long Life Study) at their homes during which additional blood samples were collected and various measurements were taken (such as blood pressure, height, weight, waist circumference, grip strength, etc.).

In October 2015, Extension Study 2 was renewed with continued follow-up planned through October 2020, pending annual contract review and renewal.

Additional Information: The WHI website, https://www.whi.org/about/SitePages/About%20WHI.aspx has much more information about the study. For WHI data collection forms used over the years, please see https://www.whi.org/researchers/studydoc/SitePages/Forms.aspx. For additional dataset documentation, see https://www.whi.org/researchers/data/Pages/Available%20Data.aspx. For data preparation and use, please refer to 'WHI dbGaP Cohort Data Release Data Preparation Guide May 2018' for additional details about the WHI data.

The WHI Cohort is utilized in the following dbGaP substudies. To view genotypes, analysis, expression data, other molecular data, and derived variables collected in these substudies, please click on the following substudies below or in the "Substudies" section of this top-level study page phs000200 WHI Cohort.

Authorized Access
Publicly Available Data (Public ftp)

Connect to the public download site. The site contains release notes and manifests. The site also contains data dictionaries, variable summaries, documents, and truncated analyses, whenever available.

Study Inclusion/Exclusion Criteria

All women enrolled in the WHI were between 50 and 79 years old and were postmenopausal at the time of enrollment. In addition, eligibility criteria for the clinical trial (CT) and observational study (OS) included ability and willingness to provide written informed consent and an intention to reside in the area for at least 3 years after enrollment. Component specific exclusion criteria are listed in Table 1 of the Baseline Monograph paper available at: https://www.whi.org/about/Baseline%20Monograph/baseline_Recruitment.pdf

Study History

  • October 1992 - Clinical Coordinating Center operations begin
  • March 1993 - 16 Clinical Centers selected
  • September 1993 - Recruitment of participants for 2 Hormone Therapy Trials (HT) trials and the Dietary Modification Trial (DM) begins
  • September 1994 - 24 additional Clinical Centers selected; Recruitment of participants for the Observational Study (OS) begins
  • June 1995 - CaD randomization begins
  • August 1998 - Randomization of participants for the DM ends
  • October 1998 - Randomization of participants for the HT ends
  • December 1998 - Recruitment of participants for the OS ends
  • September 2000 - Randomization of participants for the CaD ends
  • July 2002 - Estrogen plus Progestin HT was stopped early and main results published
  • March 2004 - Estrogen-Alone HT was stopped early
  • April 2004 - Main results of Estrogen-Alone HT published; Closeout of OS begins
  • October 2004 - Closeout of clinical trials (HT, DM, and CaD) begins
  • March 2005 - Study close-out ends
  • April 2005 - Extension study 2005-2010 (Extension 1) begins
  • September 2005 - Final WHI outcomes obtained and WHI database closed
  • February 2006 - Main results of DM and CaD published
  • September 2010 - Extension study 2005-2010 (Extension 1) closed
  • October 2010 - Extension study 2010-2015 (Extension 2) begins
  • March 2012-May 2013 - In Person Visits conducted (Long Life Study (https://www.whi.org/studies/SitePages/Long%20Life%20Study.aspx)
  • October 2015 - Extension study 2 renewed 2015-2020

About WHI: https://www.whi.org/about/SitePages/About%20WHI.aspx

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