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Trial NCT00000532

Resource URI: http://static.linkedct.org/resource/trials/NCT00000532
PropertyValue
linkedct:brief_title Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause
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/3802>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6173>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:condition <http://static.linkedct.org/resource/condition/7949>
linkedct:condition <http://static.linkedct.org/resource/condition/9106>
linkedct:criteria Premenopausal women, ages 45-50 at entry.
linkedct:description BACKGROUND: Coronary heart disease causes almost as many deaths in women as it does in men, with approximately 90 percent of the deaths in women occurring after the age of 50. There are substantial increases in coronary heart disease risk factors at the time of the menopause, especially increases in total cholesterol and low density lipoprotein cholesterol, that may well contribute to the increased risk of coronary heart disease. DESIGN NARRATIVE: A total of 275 premenopausal women were randomized to a control group and 260 women into a lifestyle intervention group, a cognitive-behavioral program which was designed to reduce total dietary fat to less than 25 percent of calories, saturated fat to less than 7 percent of calories, and cholesterol to less than 100 mg. All women were given a weight loss goal of five to 15 pounds, depending on baseline weight status and asked to reduce calorie intake to 1300 kcal until weight goal was achieved. The intervention included an intensive group program during the first six months and follow-up individual/group sessions from six through 54 months. The primary endpoints of the trial were difference in the change in LDL cholesterol and weight between intervention and assessment-only groups at the end of the trial. The intervention also compared whether the dietary intervention could prevent the increase in low density lipoprotein cholesterol and the weight gain observed at this period of a woman's life; whether dietary intervention affected the age of menopause or the percent of women using hormone therapy or having hysterectomy; and whether the dietary intervention had adverse effects on menopausal symptomatology, endogenous hormones, and bone mineral density. The Office of Research on Women's Health provided supplemental funds to measure hemostatic factors, including fibrinogen, factor VIIc and antigen, antithrombin III and PAI-1 in plasma samples for all subjects at baseline. The supplement allowed a longitudinal description of changes in hemostatic factors that appeared to occur during the perimenopausal transition and an investigation of whether diet and diet intervention altered the pattern of hemostatic changes observed at menopause. Beginning in February 1996, the trial was extended for four years through January 2000 to provide for data analysis and an additional follow-up of at least 4.5 years for all participants.
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 50 Years
linkedct:eligibility_minimum_age 45 Years
linkedct:end_date January 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000532
rdfs:label Trial NCT00000532
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000532
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 75
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000532>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/10902>
linkedct:reference <http://static.linkedct.org/resource/reference/4862>
linkedct:reference <http://static.linkedct.org/resource/reference/49244>
linkedct:reference <http://static.linkedct.org/resource/reference/49493>
linkedct:reference <http://static.linkedct.org/resource/reference/49533>
linkedct:reference <http://static.linkedct.org/resource/reference/50741>
linkedct:reference <http://static.linkedct.org/resource/reference/50940>
linkedct:reference <http://static.linkedct.org/resource/reference/53356>
linkedct:reference <http://static.linkedct.org/resource/reference/54529>
linkedct:reference <http://static.linkedct.org/resource/reference/54636>
linkedct:reference <http://static.linkedct.org/resource/reference/55309>
linkedct:reference <http://static.linkedct.org/resource/reference/55463>
linkedct:reference <http://static.linkedct.org/resource/reference/5947>
linkedct:reference <http://static.linkedct.org/resource/reference/6555>
linkedct:reference <http://static.linkedct.org/resource/reference/8897>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date February 1992
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct:summary To determine if the increase in low density lipoprotein (LDL) cholesterol at the time of menopause could be ameliorated or prevented by an intensive dietary intervention. Also, to prevent the increase in body weight and associated changes in insulin, glucose, blood pressure, triglycerides, and high density lipoprotein cholesterol during the peri- to postmenopausal period.
rdf:type linkedct:trials
linkedct:verification_date April 2002