通过配方饮食进行膳食替代比单独的生活方式干预更能减轻超重或肥胖伴心血管危险因素患者的体重——ACOORH 试验。

Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial.

机构信息

Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany.

DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany.

出版信息

Eur J Clin Nutr. 2021 Apr;75(4):661-669. doi: 10.1038/s41430-020-00783-4. Epub 2020 Oct 30.

DOI:10.1038/s41430-020-00783-4

PMID:33128036

Abstract

BACKGROUND

As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone.

METHODS

In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters.

RESULTS

From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks.

CONCLUSIONS

A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.

摘要

背景

由于配方饮食已被证明在减重方面有效，我们假设对于超重或肥胖且伴有心血管危险因素的患者，将液体配方饮食与生活方式干预相结合，在减轻体重和改善心血管危险因素方面优于单独进行生活方式干预。

方法

在这项多中心 RCT 中，463 名超重或肥胖患者（BMI：27-35kg/m²；至少有代谢综合征的另一种合并症）被随机分为仅进行生活方式干预的对照组（CON，n=155）或包括液体代餐的生活方式干预组（INT，n=308）。两组均使用远程监测设备（秤和计步器），接受有关健康饮食的信息，并被指示增加身体活动。远程监测设备自动将数据传输到个性化在线门户，并获取数据进行讨论。INT 在第一周内使用液体代餐替代三餐（约 1200kcal）。在第 2-4 周，参与者替换两餐/天，在第 5-26 周仅替换一餐/天（1300-1500kcal/天）。在 52 周后进行随访。进行意向治疗分析。主要结局为体重变化。次要结局包括代谢风险因素的变化，包括身体成分和实验室参数。

结果

从起始队列中，360 名（78%，INT：n=244；CON：n=116）和 317 名（68%，INT：n=216；CON：n=101）参与者完成了 26 周的干预阶段和 52 周的随访。两组之间的估计治疗差异（ETD）在 12 周时为-3.2kg[-4.0；-2.5]（P<0.001），在 52 周时为-1.8kg[-2.8；-0.8]（P<0.001）。