INTRODUCTION Over half of patients with acute ischemic stroke are overweight or obese as defined by a body mass index (BMI) ≥25 kg/m2. Professional and government agencies recommend weight management for these persons to improve risk factors for cardiovascular disease, including hypertension, dyslipidemia, vascular inflammation, and diabetes. However, approaches to weight loss have not been adequately tested specifically in patients with stroke. In anticipation of a larger trial with vascular or functional outcomes, we tested the feasibility and safety of a 12-week partial meal replacement (PMR) intervention for weight loss in overweight or obese patients with a recent ischemic stroke. METHODS This randomized open-label trial enrolled participants from December 2019 to February 2021 (with hiatus from March-August 2020 due to COVID-19 pandemic restrictions on research). Eligible patients had a recent ischemic stroke and BMI 27 to 49·9 kg/m². Patients were randomized to a PMR diet (OPTAVIA® Optimal Weight 4 & 2 & 1 Plan®) plus standard care (SC) or SC alone. The PMR diet consisted of four meal replacements supplied to participants, two meals with lean protein and vegetables (self-prepared or supplied) and a healthy snack (also self-prepared or supplied). The PMR diet provided 1,100 to 1,300 calories per day. SC consisted of one instructional session on a healthy diet. Co-primary outcomes were ≥5% weight loss at 12 weeks and to identify barriers to successful weight loss among participants assigned to PMR. Safety outcomes included hospitalization, falls, pneumonia or hypoglycemia requiring treatment by self or others. Due to the COVID-19 pandemic, study visits after August 2020 were by remote communication. RESULTS We enrolled 38 patients from two institutions. Two patients in each arm were lost and could not be included in outcome analyses. At 12 weeks, 9/17 patients in the PMR group and 2/17 patients in the SC group achieved ≥5% weight loss (52·9% v. 11·9%; Fisher's exact p=0·03). Mean percent weight change in the PMR group was -3·0% (SD 13·7) and -2·6% (SD 3·4) in the SC group (Wilcoxon rank sum p=0·17). No adverse events were attributed to study participation. Some participants had difficulty completing home monitoring of weight. In the PMR group, participants reported that food cravings and dislike for some food products were barriers to weight loss. CONCLUSION A PMR diet after ischemic stroke is feasible, safe and effective for weight loss. In future trials, in-person or improved remote outcome monitoring may reduce anthropometric data variation.

中文翻译：

---

中风后体重减轻的部分膳食替代：试点临床试验的结果。

简介 根据体重指数 (BMI) ≥ 25 kg/m2 的定义，超过一半的急性缺血性卒中患者超重或肥胖。专业和政府机构建议对这些人进行体重管理，以改善心血管疾病的危险因素，包括高血压、血脂异常、血管炎症和糖尿病。然而，减肥方法尚未在中风患者中得到充分测试。预计将进行更大规模的血管或功能结果试验，我们测试了 12 周部分膳食替代 (PMR) 干预对近期缺血性中风的超重或肥胖患者减肥的可行性和安全性。方法 这项随机开放标签试验招募了 2019 年 12 月至 2021 年 2 月的参与者（由于 COVID-19 大流行对研究的限制，从 2020 年 3 月至 2020 年 8 月中断）。符合条件的患者最近发生过缺血性中风且 BMI 为 27 至 49·9 kg/m²。患者被随机分配到 PMR 饮食（OPTAVIA® 最佳体重 4 & 2 & 1 Plan®）加标准治疗 (SC) 或单独接受 SC。PMR 饮食包括提供给参与者的四种代餐、两顿含瘦肉蛋白和蔬菜的正餐（自备或提供）和一份健康零食（也是自备或提供）。PMR 饮食每天提供 1,100 至 1,300 卡路里的热量。SC 包括一个关于健康饮食的指导课程。共同主要结果是 12 周时体重减轻 ≥ 5%，并确定分配到 PMR 的参与者成功减肥的障碍。安全结果包括住院、跌倒、肺炎或需要自己或他人治疗的低血糖症。由于 COVID-19 大流行，2020 年 8 月之后的研究访问是通过远程通信进行的。结果 我们从两个机构招募了 38 名患者。每组中有两名患者丢失，无法纳入结果分析。在 12 周时，PMR 组中有 9/17 名患者和 SC 组中有 2/17 名患者体重减轻≥5%（52·9% 对 11·9%；Fisher 精确 p=0·03）。PMR 组的平均体重变化百分比为 -3·0% (SD 13·7)，SC 组为 -2·6% (SD 3·4)（Wilcoxon 秩和 p=0·17）。没有不良事件归因于研究参与。一些参与者难以完成家庭体重监测。在 PMR 组中，参与者报告说，对食物的渴望和对某些食品的厌恶是减肥的障碍。结论 缺血性卒中后采用 PMR 饮食减肥是可行、安全和有效的。在未来的试验中，面对面或改进的远程结果监测可能会减少人体测量数据的变化。