Weight loss with a behavioral program using meal replacements, fruit and vegetables: a 24-week randomized, controlled trial

The efficacy and safety of behavioral programs using meal replacements (MR), fruit and vegetables (F/V) are well documented (Anderson JW, JADA Aug09) but randomized controlled trials (RCT) have not been done. This RCT compared a standardized behavioral program using 5 MR and 5 svg of F/V daily with usual care dietetic counseling. Healthy mildly or moderately obese subjects (BMI 30-40 kg/m2) were randomized to RD counseling or “Healthy Solutions” (HS) utilizing 3 shakes, 2 entrees and 5 svg F/V daily (~1200 kcal/d). Control (C) subjects received counseling by a RD skilled in weight management counseling at baseline, 8 and 16 weeks. The HS group attended 90 minute weekly weight loss classes for 16 weeks and 1 hr “Weight Maintenance” classes for 8 weeks. At baseline, 8, 16 and 24 weeks all subjects had: adverse event assessment; triplicate weight, waist and blood pressure measurements; fasting blood for chemistry and lipids. The HS group was instructed to: keep daily records of MR, F/V, food, physical activity; make midweek phone calls. Subject enrollments were: C, 16; HS, 22. Baseline age (47.9 y), % female (76%), race/ethnicity, BMI (35.4) did not differ between groups. Completion rates were: C, 13 (81%), HS, 18 (82%). Reported adverse events were similar in C and HS groups. Adherence to behavioral guidelines were good to excellent: class attendance, 97%; midweek calls, 93%; weekly summaries, 99%; minimum MR use, 88%; no intake of food not prescribed, 88%. Mean food intakes, svg/week, were: shakes (goal 21), 24; entrees (goal 14), 15; bars (optional), 5; F/V (goal 35), 43. Incremental physical activity (goal >2000 kcal) was 2234 kcal/wk. Weight losses for available cases at 8, 16 and 24 wks were: C group-- 1.7% (se 0.7), 1.5% (1), 1.4% (1.1) or 3.1 pounds; and HS group—8.7% (0.9), 14.3% (0.8), 16.3% (0.9) or 37 pounds. Mean weight loss at 24 wks for intention-to-treat and completer analyses, respectively, were: C, 0.7 (se 1.1)%, 0.6 (1.2)% or 1.3 pounds; HS, 13.8 (1.1)%, 15.4 (1.0)% or 33.5 pounds (P<0.0001 vs. C). Reductions in waist circumference, fasting serum glucose, cholesterol, and LDL-cholesterol were significantly greater in HS vs. C group. This RCT documented that a behavioral program with low-energy diets including MR and F/V was well tolerated and associated with significantly greater weight losses, reductions in waist circumference, reductions in serum glucose, and reductions in serum cholesterol values than usual care RD counseling.