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Trial NCT00000481

Resource URI: http://static.linkedct.org/resource/trials/NCT00000481
linkedct:brief_title Women's Health Trial: Feasibility Study in Minority Populations
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5381>
linkedct:condition <http://static.linkedct.org/resource/condition/10439>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 69 Years
linkedct:eligibility_minimum_age 50 Years
linkedct:end_date January 1996
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000481
rdfs:label Trial NCT00000481
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000481
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 71
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/1052>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/59907>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60594>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000481>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/4718>
linkedct:reference <http://static.linkedct.org/resource/reference/51370>
linkedct:reference <http://static.linkedct.org/resource/reference/53383>
linkedct:reference <http://static.linkedct.org/resource/reference/55093>
linkedct:reference <http://static.linkedct.org/resource/reference/5524>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1991
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2001