The primary goal of the Clinical Trial-Cardiovascular Risk Factors and Menopause (Women's Healthy Lifestyle Project [WHLP]) is to prevent the increase in LDL cholesterol during the peri- to postmenopausal period. The secondary goals are to prevent the increase in body weight, and the associated changes in insulin, glucose, blood pressure, triglycerides and HDLc during the peri- to postmenopausal period. The investigators propose to continue this clinical trial for four more years. The trial was originally planned for seven years. They have completed four years as of February 1996. Three more years will complete the trial as originally proposed and allow 6 months in years 8 for detailed data analysis. The trial has successfully recruited 535 women, 35 above the goal of 500. All women were premenopausal at entry with a mean age of 47 years. There have been only three dropouts from the study to date. The women were randomly assigned to Intervention or Assessment Only groups. The primary endpoint of the trial is the difference in LDLc between Intervention or Assessment groups at the 54 month visit. The intervention includes decrease in fat intake to less than 25% of calories, saturated fat <7%, cholesterol intake to <100mg, a moderate decrease in total calories, and an increase in physical activity. Self- reported dietary data show significant decreases in total calories, percent of calories from fat, saturated fat and cholesterol intake in the Intervention group. Exercise also increased substantially. There were little changes in diet or exercise in the Assessment Only group. At baseline the women had a total cholesterol level of 190mg%, LDLc of 115mg%, BMI of 25, and weighed 148 pounds. At 6 months the LDLc was 116mg% and at 18 months 118mg% in the Assessment group versus 104mg% at 6 months and 109mg% at 18 months in the Intervention group (p=.000 at 6 months, and .004 at 18 months). Body weight was 147 pounds at both 6 and 18 months in the Intervention group (p values=.000). There were also significant changes in clotting factors in the Intervention group at 6 months. There were no significant changes in bone mineral density at either the 6 or 18 months visits in either group, and the intervention has positively affected depressive mood and menopausal symptoms.
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