CLINICAL-EVALUATION OF A MINIMAL INTERVENTION MEAL REPLACEMENT REGIMEN FOR WEIGHT-REDUCTION

Objective: The purpose of this study was to evaluate a simplified weight loss program in which subjects were provided a widely available meal replacement product and its package insert information (Ultra Slim-Fast). Method: Weekly follow-up visits were carried out by non-physician personnel for weight measurement, distribution of product, and completion of a subjective questionnaire. No dietary counseling was provided. A total of 273 of 301 subjects (91%) completed 12 weeks of study. Men lost 50% (from 119 to 108% of ideal body weight) and women lost 35% (from 122 to 111% of ideal body weight) of excess body weight. Thirty-five patients who lost <9 lbs in 12 weeks were considered non-adherent and were excluded from the next phase of the study during which 238 subjects were followed biweekly. Results: Despite a $25/week payment for participation nearly 44% of subjects dropped out or were judged non-compliant prior to the end of the study. At 116 weeks, 133 (97 females, 36 males) of 238 subjects remained in the study (44% of the initial population), with average weight loss from baseline of 13.6 +/- 10.5 lb in females and 14.0 +/- 10.5 lb in males. Discussion: The weight loss observed (approximately 10% of body weight) is significant and has been associated with important health benefits particularly for patients with hypertension and noninsulin dependent diabetes. The potential advantages of using meal replacements for mild obesity include wide availability to aid compliance, low cost and minimal professional intervention.