Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000481
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
1999-10-27
Brief Title:
Womens Health Trial Feasibility Study in Minority Populations
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Womens 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 andor 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
The Request for Proposal for the Womens 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 andor 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CN025427-010 | NIH | None | httpsreporternihgovquickSearchN01CN025427-010 |