Women's Health Trial: Feasibility Study in Minority Populations
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, fat-restricted
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000481
First Posted
October 27, 1999
Last Updated
February 13, 2017
Sponsor
National Cancer Institute (NCI)
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000481
Brief Title
Women's Health Trial: Feasibility Study in Minority Populations
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 1991 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1996 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
Detailed Description
BACKGROUND:
The Request for Proposal for the Women's Health Trial: Feasibility Study in Minority Populations was developed and released by the National Cancer Institute with assistance from the National Heart, Lung, and Blood Institute.
DESIGN NARRATIVE:
Randomized. Recruitment began in August 1992 and ended in February 1994. Forty percent of the subjects were randomized to a control group and 60 percent to the dietary intervention group. Dietary counseling aimed to reduce total fat to 20 percent of calories, reduce saturated fat and dietary cholesterol intakes, and to increase the intake of fruits, vegetables, and grain products. Recruitment and randomization were conducted over an 18-month period at three clinical centers. Other objectives of the trial included: development and evaluation of strategies for recruiting and retaining women of different racial and SES groups into a dietary intervention study; identification of factors affecting compliance; assessment of the effects of a modified fat eating pattern on cardiovascular disease risk factors, including fasting blood lipids and lipoproteins, glucose and insulin, body weight and blood pressure; identification and assessment of potential biochemical and/or biological markers for dietary adherence.
Close-out visits began in May 1994 and ended in September 1994. These visits included six, twelve, and eighteen-month follow-up. NCI extended the coordinating center contract through January 1996 to support data analysis and publication of research results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Postmenopause
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet, fat-restricted
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie George
Organizational Affiliation
University of Miami
First Name & Middle Initial & Last Name & Degree
W. Hall
Organizational Affiliation
Emory University
First Name & Middle Initial & Last Name & Degree
Albert Oberman
Organizational Affiliation
University of Alabama at Birmingham
12. IPD Sharing Statement
Citations:
PubMed Identifier
8978881
Citation
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.
Results Reference
background
PubMed Identifier
10369504
Citation
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.
Results Reference
background
PubMed Identifier
9384206
Citation
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. Erratum In: Am J Epidemiol 1998 Oct 15;148(8):820.
Results Reference
background
PubMed Identifier
10512559
Citation
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.
Results Reference
background
PubMed Identifier
9741867
Citation
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.
Results Reference
background
PubMed Identifier
29779054
Citation
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.
Results Reference
derived
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Women's Health Trial: Feasibility Study in Minority Populations
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