Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial.

Objectives: In this paper, we present the results of changes in risk factors by use of hormone therapy (HT) at 18 months in the Women On the Move through Activity and Nutrition (WOMAN) randomized trial.

Methods: The trial was designed to test the hypothesis that aggressive dietary changes and increased physical activity to reduce weight, waist circumference (WC), glucose, insulin, and lipoproteins would reduce progression of subclinical atherosclerosis, carotid intimal media thickness and plaque, coronary artery calcification, and pulse wave velocity (PWV). The study focused on postmenopausal women (n = 508), mean age of 57, who were randomized to the Lifestyle Change (LC) or Health Education (HE) group.

Results: At 18 months of follow-up, there was significant, 17 lb, weight loss and 10 cm WC decrease in the LC group. There were significant differences in changes in low-density lipoprotein cholesterol (LDL-C), insulin, glucose, large LDL, and LDL particles between the LC and HE groups. Risk factor changes were greater for women in the LC who lost a significant amount of weight (>or=18.8 lb). Participants at 18 months were subdivided into women who had stayed on HT, 125 (28%); stopped HT after randomization, 145 (33%); and not on HT at baseline but stopped an average of 7 months prior to randomization, 173 (39%). Weight loss in the LC was similar for all three groups, but LDL lipoprotein response was better for women who stopped HT after randomization or were not on HT at baseline.

Conclusions: The trial has been successful in increasing exercise and diet changes and reduction in weight and WC and variables related to metabolic syndrome.