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 non-insulin dependent diabetes. The potential advantages of using meal replacements for mild obesity include wide availability to aid compliance, low cost and minimal professional intervention.