The clinical trial of Women On the Move through Activity and Nutrition (WOMAN) study

Abstract

The Women On the Move through Activity and Nutrition (WOMAN) study is the first randomized clinical trial of nonpharmacological intervention designed to modify lipoproteins, weight loss and exercise among postmenopausal women using noninvasive measures of atherosclerosis as the primary endpoint. The trial was initially designed to test whether intervention as compared to health education would be more effective in slowing progression of subclinical atherosclerosis among women on hormone therapy (HT), estrogen or estrogen+progestin. It was designed and implemented prior to the results of the Women's Health Initiative (WHI). The trial was since modified to include women who had been on HT but went off after the results of the WHI were reported. Eligible women were between the ages of 52-62, had waist circumference>or=80 cm, low density lipoprotein cholesterol between 100-160 mg% and controlled blood pressure. The intervention is low in total and saturated fat, trans fats, higher in fiber and promotes loss of 7-10% of body weight and includes at least 150 min of physical activity per week. The study has recruited 508 women. The primary endpoints are change in extent of carotid intima-media wall thickness as measured by carotid ultrasound, pulse wave velocity as a measure of vascular stiffness and coronary artery calcium using electron beam computed tomography. Body composition is measured by dual-energy X-ray absorptiometry.