Multicenter randomized trail of a comprehensive prepared meal program in type 2 diabetes

OBJECTIVE - To evaluate the clinical effects of a comprehensive prepackaged meal plan, incorporating the overall dietary guidelines of the American Di abetes Association and other national health organizations, relative to tho se of a self-selected diet based on exchange lists in free-living individua ls with type 2 diabetes. RESEARCH DESIGN AND METHODS - A total of 202 women and men (BMI less than o r equal to 42 kg/m(2)) whose diabetes was treated with diet alone or an ora l hypoglycemic agent were enrolled at 10 medical centers. After a dr-week b aseline period, participants were randomized to a nutrient-fortified prepar ed meal plan or a self-selected exchange-list diet for 10 weeks. On a calor ic basis, both interventions were designed to provide 55-60% carbohydrate, 20-30% fat, and 15-20% protein. At intervals, 3-day food records were compl eted, and body weight, glycemic control, plasma lipids, and blood pressure were assessed. RESULTS - Food records showed that multiple nutritional improvements were a chieved with both diet plans. There were significant overall reductions in body weight and BMI, fasting plasma glucose and serum insulin, fructosamine , HbA(1c), total and LDI cholesterol, and blood pressure (P < 0.001 or bett er for all). In general, differences in major end points between the diet p lans were not statistically significant. CONCLUSIONS - Glycemic control and cardiovascular risk factors improve in i ndividuals with type 2 diabetes who consume diets in accordance with the Am erican Diabetes Association guidelines. The prepared meal program was as cl inically effective as the exchange-list diet. The prepared meal plan has th e additional advantages of being easily prescribed and eliminating the comp lexities of meeting the multiple dietary recommendations for type 2 diabete s management.