Abstract 156: Main Results Of The Take Off Pounds After Stroke Trial

Abstract

Objective: To test the effectiveness of a 12-week partial meal replacement (PMR) intervention for achieving meaningful weight loss in overweight or obese patients with a recent ischemic stroke. Methods: Take Off Pounds After Stroke (TOPS) was a prospective randomized open blinded endpoint trial. Eligible patients had an ischemic stroke within the past 90 days, were ≥18 years of age, with BMI 27 to 49.9 kg/m 2 , maximum weight ≤350 pounds (limit of home scale we provided), and were able to stand on a scale unassisted, meet all nutritional needs by oral intake, and ready to undergo behavioral change. Patients were excluded if they required dialysis, had a contra-indication to a weight loss diet, had lost ≥12 lbs in the prior 3 months, were allergic to soy, did not speak English or were pregnant, breast feeding, or desired to become pregnant. Patients were randomized to a PMR (OPTAVIA® Optimal Weight 4&2&1 Plan™) or enhanced standard care (SC). The PMR program is commercially available and consists of daily intake of four meal replacements, two “lean and green” meals and one healthy snack (1,100 to 1,300 calories per day). Enhanced standard care consisted of one instructional session on a healthy diet advocated by the US Department of Agriculture (and provision of a manual). The primary outcome was achievement of at least 5% weight loss at 12 weeks. Results: From 1 2/2019 to 2/2021, a total of 38 patients were enrolled from two sites. Two patients in each arm did not complete the study. At 12 weeks, 9 of 17 patients in the PMR group and 2 of 17 patients in the SC group achieved at least 5% weight loss (52.9% v. 11.9%; Fisher’s exact p=.02). Mean percent weight loss in the PMR group was 3.0% (SD 13.7) compared with 2.6% (SD 3.4) in the SC group (Wilcoxon rank sum p=.17). Patients in the PMR group had a mean change in waist circumference of -5.0 cms (SD 9.8) compared to -4.7 cms (SD 6.3) in the standard advice group (ANOVA p=.94). Changes in blood pressure and modified Rankin Scale did not differ between groups. No adverse outcomes were associated with the study intervention. Conclusion: A dietary intervention for weight loss implemented soon after ischemic stroke is feasible, safe and effective for weight loss.