Women's Healthy Lifestyle Project: A randomized clinical trial - Results at 54 months

Background-The Women's Healthy Lifestyle Project Clinical Trial tested the hypothesis that reducing saturated fat and cholesterol consumption and prev enting weight gain by decreased caloric and fat intake and increased physic al activity would prevent the rise in LDL cholesterol and weight gain in wo men during perimenopause to postmenopause. Methods and Results-There were 275 premenopausal women randomized into the assessment only group and 260 women into the intervention group. The mean a ge of participants at baseline was 47 years, and 92% of the women were whit e. The mean LDL cholesterol was 115 mg/dL at baseline, and mean body mass i ndex was 25 kg/m(2). The follow-up through 54 months was excellent. By 54 m onths, 35% of the women had become postmenopausal. At the 54-month examinat ion, there was a 3.5-mg/dL increase in LDL cholesterol in the intervention group and an 8.9-mg/dL increase in the assessment-only group (P=0.009). Wei ght decreased 0.2 lb in the intervention and increased 5.2 lb in the assess ment-only group (P=0.000). Triglycerides and glucose also increased signifi cantly more in the assessment-only group than in the intervention group. Wa ist circumference decreased 2.9 cm in the intervention compared with 0.5 cm in the assessment-only group (P=0.000). Conclusions-The trial was successful in reducing the rise in LDL cholestero l during perimenopause to postmenopause but could not completely eliminate the rise in LDL. cholesterol. The trial was also successful in preventing t he increase in weight from premenopause to perimenopause to postmenopause. The difference in LDL cholesterol between the assessment and intervention g roups was most pronounced among postmenopausal women and occurred among hor mone users and nonusers.