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Original Investigation
July 24, 2000

A Randomized Trial of Improved Weight Loss With a Prepared Meal Plan in Overweight and Obese Patients: Impact on Cardiovascular Risk Reduction

Author Affiliations

From the Division of Nephrology, Hypertension, and Clinical Pharmacology, Department of Medicine, Oregon Health Sciences University (Drs Metz, Morris, Hatton, and McCarron, Ms Reusser, and Mr Snyder), and the Clinical Research Group of Oregon (Dr Clark and Mss Chester and McMahon), Portland; and Division of Clinical Nutrition and Metabolism, Departments of Nutrition and Internal Medicine, University of California at Davis (Dr Stern); the Nutrition Department, College of Health and Human development, Pennsylvania State University, University Park (Dr Oparil); the Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario (Dr Haynes); the Division of Endocrinology/Hypertension, Wayne State University Medical Center, Detroit, Mich (Dr Resnick); and the Division of Endocrinology, Diabetes, and Nutrition, St Luke's/Roosevelt Hospital, Columbia University, New York, NY (Dr Pi-Sunyer).

Arch Intern Med. 2000;160(14):2150-2158. doi:10.1001/archinte.160.14.2150

Objective  To assess the long-term effects of a prepackaged, nutritionally complete, prepared meal plan compared with a usual-care diet (UCD) on weight 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 randomized to the nutrient-fortified prepared meal plan (approximately 22% energy from fat, 58% from carbohydrate, and 20% from protein) or to a macronutrient-equivalent UCD.

Main Outcome Measures  The primary outcome measure was weight change. Secondary measures were changes in blood pressure or plasma lipid, lipoprotein, glucose, or glycosylated hemoglobin levels; quality of life; nutrient intake; 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 UCD 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 improved blood pressure, total and low-density lipoprotein cholesterol levels, glycosylated hemoglobin level, and quality of life (P<.02); in the diabetic group, the glucose level was reduced (P<.001). Compared with those in the UCD group, participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total (P<.01) and high-density lipoprotein (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 improvements in quality of life (P<.05) and compliance (P<.001) than the UCD group.

Conclusions  Long-term dietary interventions induced significant weight loss and improved cardiovascular risk in high-risk patients. The prepared meal plan simultaneously provided the simplicity and nutrient composition necessary to maintain long-term compliance and to reduce cardiovascular risk.