Cardiovascular DiseasesPhase 3NCT00000481
Women's Health Trial: Feasibility Study in Minority Populations
A Phase 3 study testing diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by National Cancer Institute (NCI).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- diet, fat-restricted
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Jan 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Postmenopause
- Being tested
- diet, fat-restricted
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet, fat-restrictedBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startSep 1991
- Study completionJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Valerie George, University of MiamiW. Hall, Emory UniversityAlbert Oberman, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000481
- Sponsor's protocol ID
- 71
- Other IDs
- N01CN025427-010
- Status last verified
- Feb 2017
- First submitted
- 27 Oct 1999
- Last updated
- 14 Feb 2017
- Results posted
- No
Publications
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.
PubMed 8978881Coates 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.
PubMed 10369504Kristal 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.
PubMed 9384206Kristal 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.
PubMed 10512559Lewis 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.
PubMed 9741867Bhargava 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.
PubMed 29779054
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Health Trial: Feasibility Study in Minority Populations
- ClinicalTrials.gov ID
- NCT00000481
- Acronym / sponsor ID
- 71
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Postmenopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1991
- Study completion
- Jan 1996
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet, fat-restricted | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Background: PubMed 8978881Bowen 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.
- Background: PubMed 10369504Coates 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.
- Background: PubMed 9384206Kristal 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.
- Background: PubMed 10512559Kristal 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.
- Background: PubMed 9741867Lewis 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.
- Derived from this study: PubMed 29779054Bhargava 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie George
University of Miami
W. Hall
Emory University
Albert Oberman
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by National Cancer Institute (NCI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000481, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.