A randomized trial of improved weight loss with a prepared meal plan in overweight and obese patients - Impact on cardiovascular risk reduction

Objective: To assess the long-term effects of a prepackaged, nutritionally complete, prepared meal plan compared with a usual-care diet (UCD) on weigh t loss and cardiovascular risk factors in overweight and obese persons. Design: In this randomized multicenter study, 302 persons with hypertension and dyslipidemia (n=183) or with type 2 diabetes mellitus (n=119) were ran domized to the nutrient-fortified prepared meal plan (approximately 22% ene rgy from fat, 58% from carbohydrate, and 20% from protein) or to a macronut rient-equivalent UCD. Main Outcome Measures: The primary outcome measure was weight change. Secon dary measures were changes in blood pressure or plasma lipid, lipoprotein, glucose, or glycosylated hemoglobin levels; quality of life; nutrient intak e; and dietary compliance. Results: After 1 year, weight change in the hypertension/dyslipidemia group was -5.8+/-6.8 kg with the prepared meal plan vs -1.7+/-6.5 kg with the UC D plan (P<.001); for the type 2 diabetes mellitus group, the change was -3. 0+/-5.4 kg with the prepared meal plan vs -1.0+/-3.8 kg with the UCD plan ( P<.001) (data given as mean+/-SD). In both groups, both interventions impro ved blood pressure, total and low-density lipoprotein cholesterol levels, g lycosylated hemoglobin level, and quality of life (P<.02); in the diabetic group, the glucose level was reduced (P<.001). Compared with those in the U CD group, participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total (P<.01) and high-density li poprotein (P<.03) cholesterol levels, systolic blood pressure (P<.03), and glucose level (P<.03); in participants with type 2 diabetes mellitus, there were greater improvements in glucose (P=.046) and glycosylated hemoglobin (P<.02) levels. The prepared meal plan group also showed greater improvemen ts in quality of life (P<.05) and compliance (P<.001) than the UCD group. Conclusions: Long-term dietary interventions induced significant weight los s and improved cardiovascular risk in high-risk patients. The prepared meal plan simultaneously provided the simplicity and nutrient composition neces sary to maintain long-term compliance and to reduce cardiovascular risk.