We are proposing a 2 year continuation of the Women On the Move through Activity And Nutrition Study, NIH# HL66468-05. The primary goal of this trial is to determine whether a nonpharmacological intervention that includes weight loss, exercise and low saturated fat and cholesterol diet and moderate increase in polyunsaturates will result in the slowing of progression of subclinical atherosclerosis as measured by changes in coronary artery calcium (CAC), carotid intima media thickness (IMT) and plaque and pulse wave velocity (PWV). To be eligible for the trial the women had to have a waist circumference (WC) of 80 cm, age 50-62 and low density lipoprotein cholesterol (LDLc) of 100-160 mg% and body mass index between 25-39.9 kg/m2. All had to be normotensive but could be on antihypertensive therapy. Randomization into intervention (Lifestyle Change [LC], n=253) and comparison (Health Education [HE], n= 255) began in 4/2002 and was completed in 10/2003. The rationale for the trial based on the results of our previous studies showing that increase in weight from the peri- to post-menopause, increase in WC and insulin resistance, increased triglyceride levels, reductions in high density lipoprotein cholesterol (HDLc) and increase in glucose and insulin was associated with a substantial increase risk of atherosclerosis as measured by subclinical disease and heart disease in postmenopausal women, that oral estrogen therapy would further raise triglyceride levels, small LDL particles, total LDL particles and apolipoprotein-B and that this possible adverse effect of hormone therapy (HT) could perhaps blunt the proposed benefits. Our hypothesis was borne out, unfortunately, by the results of the Women's Health. At baseline, 60% were on HT and at 30 months, 24%. At 30 months, close to 90% were still participating. At 30 months, there was a 12.6 Ib. weight loss in the LC group, 8.4 cm decrease in WC and significant differences in the LC versus HE group in LDLc, HDLc, triglycerides, insulin and glucose. There was also a significant difference in the %-mile corridor walk, a measure of exercise performance. In both the LC and HE groups there was also a very strong association between risk factor changes and changes in weight. This is one of the first and currently the only study in healthy postmenopausal women to evaluate whether aggressive lifestyle interventions focusing on weight loss and decrease in WC can stop the progression of subclinical atherosclerosis. ? ? ?
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