Emilie Combet, Laura Haag, Janice Richardson, Caroline E. Haig, Yvonne Cunningham, Heather L. Fraser, Naomi Brosnahan, Tracy Ibbotson, Jane Ormerod, Chris White, Emma McIntosh, Catherine A. O’Donnell, Naveed Sattar, Alex McConnachie, Michael E. J. Lean, David N. Blane
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Adults with LC (symptoms >12 weeks) and body mass index >27 kg m−2 (>25 kg m−2 for South Asians) were randomized (n = 234, 1:1) to control (n = 116, usual care) or the remotely delivered structured weight management (n = 118, total diet replacement (850 kcal per day) for 12 weeks, followed by food reintroduction and weight loss maintenance support) via minimization and randomization (80:20) to balance dominant LC symptom, sex, age, ethnicity and postcode-based index of multiple deprivation between groups. The control group received the intervention after 6 months. Participants selected the dominant LC symptom they would most like to improve (fatigue, breathlessness, pain, anxiety/depression or other) as the prespecified respective primary outcome. Individual symptoms were assessed using validated questionnaires and a visual analog scale for those without prespecified scales. 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引用次数: 0
摘要
长冠状病毒病(LC)是一种复杂的多症状疾病,目前尚无已知的改善疾病的治疗方法。这项等待名单控制的开放标签试验测试了远程交付的结构化体重管理程序是否可以改善超重人群的LC症状。患有LC(症状>;12周)和体重指数>;27 kg m - 2 (>;25 kg m - 2的南亚人)的成年人被随机(n = 234, 1:1)随机分配到对照组(n = 116,常规护理)或远程提供结构化体重管理(n = 118,总饮食替代(每天850千卡),持续12周,然后重新引入食物和减肥维持支持),通过最小化和随机化(80:20)来平衡主要的LC症状、性别、年龄、基于种族和邮政编码的群体多重剥夺指数。对照组于6个月后接受干预。参与者选择他们最想改善的主要LC症状(疲劳、呼吸困难、疼痛、焦虑/抑郁或其他)作为预先指定的各自的主要结局。使用有效的问卷和视觉模拟量表对没有预先指定量表的患者进行个体症状评估。6个月时,干预组的主要结局(变化- 1.16(标准差1.42),分析n = 97)较对照组(变化- 0.83(标准差1.14),分析n = 117)有所改善,治疗效果为- 0.34(95%可信区间- 0.67至- 0.01),未发生过多严重不良事件。国际标准随机对照试验号注册:ISRCTN12595520。
Remotely delivered weight management for people with long COVID and overweight: the randomized wait-list-controlled ReDIRECT trial
Long COVID (LC) is a complex multisymptom condition with no known disease-modifying treatments. This wait-list-controlled open-label trial tested whether a remotely delivered structured weight management program could improve respective LC symptoms in people living with overweight. Adults with LC (symptoms >12 weeks) and body mass index >27 kg m−2 (>25 kg m−2 for South Asians) were randomized (n = 234, 1:1) to control (n = 116, usual care) or the remotely delivered structured weight management (n = 118, total diet replacement (850 kcal per day) for 12 weeks, followed by food reintroduction and weight loss maintenance support) via minimization and randomization (80:20) to balance dominant LC symptom, sex, age, ethnicity and postcode-based index of multiple deprivation between groups. The control group received the intervention after 6 months. Participants selected the dominant LC symptom they would most like to improve (fatigue, breathlessness, pain, anxiety/depression or other) as the prespecified respective primary outcome. Individual symptoms were assessed using validated questionnaires and a visual analog scale for those without prespecified scales. At 6 months, the primary outcome improved in the intervention group (change −1.16 (s.d. 1.42), n = 97 analyzed) compared with the control group (change −0.83 (s.d. 1.14), n = 117 analyzed) with a treatment effect of −0.34 (95% confidence interval −0.67 to −0.01), with no excess of serious adverse events. International Standard Randomised Controlled Trial Number Registry registration: ISRCTN 12595520 . In a randomized trial, a remotely delivered weight management intervention for people with long COVID and excess weight improved respective long COVID symptoms and quality of life and resulted in substantial weight loss when compared with a control group, with no serious adverse effects reported.
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