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

The Women on the Move through Activity and Nutrition (WOMAN) study was designed to test whether a nonpharmacological intervention including qualitative and quantitative dietary changes to induce weight loss and increased physical activity levels would reduce blood triglyceride levels and number of low-density lipoprotein particles (LDL-P). Such decreases in lipoproteins and other risk factors could reduce or slow progression of subclinical cardiovascular disease (CVD). Study participants were randomized to either the intervention (Lifestyle Change) or assessment (Health Education) group. Most of the intervention ended at the 30-month visit. The last 48-month examination was completed in 9/2008. There was very substantial weight loss and increased exercise during the first 30 months of the trial resulting in significant decreases in CV risk factors. Most of the intervention effect was lost through 48 months. Weight loss was 3.4 kg in Lifestyle Intervention and 0.2 kg in the Health Education at 48 months (P = 0.000). There were no significant changes at 48 months in lipid levels, blood pressure (BP), glucose, insulin, or in the subclinical measures of coronary calcium, carotid intima media thickness, or plaque. There was a significant decrease in long-distance corridor walk time in the Lifestyle vs. Health Education groups. Significant lifestyle changes can be achieved that result in decreases in CV risk factors. Whether such changes reduce CV outcomes is still untested in clinical trials of weight loss or exercise. Long-term maintenance of successful lifestyle changes, weight loss and reduced risk factors is the hurdle for lifestyle interventions attempting to prevent CV and other chronic diseases.

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 ≥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 minutes 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.

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Background Standard behavioral obesity treatment produces poor long-term results. Focusing on healthy eating behaviors, rather than caloric intake, may be an alternative strategy. Furthermore, important behaviors might differ for short- vs. long-term weight control. Objective To describe and compare associations between changes in eating behaviors and weight after 6 and 48 months Design Secondary analysis of data collected during a randomized weight loss intervention trial with 48-month follow-up Participants 465 overweight and obese postmenopausal women enrolled in the Women on the Move through Activity and Nutrition (WOMAN) Study Main outcome measures Changes in weight from baseline to 6 and 48 months. Statistical analyses performed Linear regression models examined the associations between 6- and 48-month changes in eating habits assessed by the Conner Diet Habit Survey and changes in weight. Analyses were conducted in the combined study population and stratified by randomization group. Results At 6 months in the combined population, weight loss was independently associated with decreased desserts (p<0.001), restaurant eating (p=0.042), sugar-sweetened beverages (p=0.009), and fried foods (p<0.001), and increased fish consumption (p=0.003). Results were similar in intervention participants; only reduced desserts and fried foods associated with weight loss in controls. At 48 months in the combined population, weight loss was again associated with decreased desserts (p=0.003) and sugar-sweetened beverages (p=0.011), but also decreased meats/cheeses (p=0.024) and increased fruits/vegetables (p<0.001). Decreased meats/cheeses predicted weight loss in intervention participants; desserts, sugar-sweetened beverages, and fruits/vegetables were independently associated in controls. Conclusions Changes in eating behaviors were associated with weight change, though important behaviors differed for short- and long-term weight change and by randomization group. Future studies should determine whether interventions targeting these behaviors could improve long-term obesity treatment outcomes.

Using the artificial beta-cell (Biostator), we determined the insulin requirements in five nonobese type I (insulin-dependent) diabetic subjects who received isocaloric 40 and 60% mixed-carbohydrate diets in a crossover randomized fashion for 4 days, each day consisting of four equal meals. This was followed on day 5 by a "Big Mac Attack" lunch consisting of a Big Mac, french fries, and milk shake. Insulin requirements to maintain normoglycemia were calculated for each 24-h period and for the 2 h after each meal. The mean 24-h insulin requirements to maintain normoglycemia was greater for the 60% carbohydrate diet than the 40% diet. Although the four meals were of equal size, in all patients the insulin required to cover breakfast greater than lunch greater than dinner greater than or equal to snack. Expressed as milliunits per kilocalorie, the amount of insulin to cover breakfast was greater for the 60% (P less than .05) than the 40% carbohydrate diet and greater for breakfast than the other meals (P less than .01). Insulin requirements for the Big Mac (43% carbohydrate) were 58% greater than for the 40% carbohydrate diet, even after correction for caloric differences. In summary, 1) increasing dietary carbohydrate from 40 to 60% results in an increased insulin requirement for meals only; 2) insulin requirements are greater in the morning than in the evening, even when meal size is constant; and 3) very large meals with high fat and carbohydrate content result in a major increase in insulin requirement. These data indicate that diet has an important impact on insulin requirements in diabetes.

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