NCT00000481

Brief Summary

To evaluate the feasibility of recruiting women of different socioeconomic status and minority groups and to determine whether these women could achieve and maintain a modified fat-eating pattern. The full-scale trial sought to determine whether a low-fat diet could decrease the incidence of cancer and coronary heart disease in postmenopausal women. The National Heart, Lung, and Blood Institute contributed funds over a three-year period to measure lipids, lipoproteins, and other cardiovascular disease risk factors.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1991

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1991

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1996

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

First QC Date

October 27, 1999

Last Update Submit

February 13, 2017

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial IschemiaPostmenopause

Interventions

diet, fat-restrictedBEHAVIORAL

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (6)

  • Bowen D, Clifford CK, Coates R, Evans M, Feng Z, Fouad M, George V, Gerace T, Grizzle JE, Hall WD, Hearn M, Henderson M, Kestin M, Kristal A, Leary ET, Lewis CE, Oberman A, Prentice R, Raczynski J, Toivola B, Urban N. The Women's Health Trial Feasibility Study in Minority Populations: design and baseline descriptions. Ann Epidemiol. 1996 Nov;6(6):507-19. doi: 10.1016/s1047-2797(96)00072-5.

    PMID: 8978881BACKGROUND

  • Coates RJ, Bowen DJ, Kristal AR, Feng Z, Oberman A, Hall WD, George V, Lewis CE, Kestin M, Davis M, Evans M, Grizzle JE, Clifford CK. The Women's Health Trial Feasibility Study in Minority Populations: changes in dietary intakes. Am J Epidemiol. 1999 Jun 15;149(12):1104-12. doi: 10.1093/oxfordjournals.aje.a009764.

    PMID: 10369504BACKGROUND

  • Kristal AR, Feng Z, Coates RJ, Oberman A, George V. Associations of race/ethnicity, education, and dietary intervention with the validity and reliability of a food frequency questionnaire: the Women's Health Trial Feasibility Study in Minority Populations. Am J Epidemiol. 1997 Nov 15;146(10):856-69. doi: 10.1093/oxfordjournals.aje.a009203.

    PMID: 9384206BACKGROUND

  • Kristal AR, Shattuck AL, Patterson RE. Differences in fat-related dietary patterns between black, Hispanic and White women: results from the Women's Health Trial Feasibility Study in Minority Populations. Public Health Nutr. 1999 Sep;2(3):253-62. doi: 10.1017/s1368980099000348.

    PMID: 10512559BACKGROUND

  • Lewis CE, George V, Fouad M, Porter V, Bowen D, Urban N. Recruitment strategies in the women's health trial: feasibility study in minority populations. WHT:FSMP Investigators Group. Women's Health Trial:Feasibility Study in Minority Populations. Control Clin Trials. 1998 Oct;19(5):461-76. doi: 10.1016/s0197-2456(98)00031-2.

    PMID: 9741867BACKGROUND

  • Bhargava A. Dietary Modifications and Lipid Accumulation Product Are Associated with Systolic and Diastolic Blood Pressures in the Women's Health Trial: Feasibility Study in Minority Populations. Curr Hypertens Rep. 2018 May 19;20(6):50. doi: 10.1007/s11906-018-0846-2.

    PMID: 29779054DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Valerie George

    University of Miami

  • W. Hall

    Emory University

  • Albert Oberman

    University of Alabama at Birmingham

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1991

Study Completion

January 1, 1996

Last Updated

February 14, 2017

Record last verified: 2017-02