Combet Emilie, Haag Laura, Richardson Janice, Haig Caroline E, Cunningham Yvonne, Fraser Heather L, Brosnahan Naomi, Ibbotson Tracy, Ormerod Jane, White Chris, McIntosh Emma, O'Donnell Catherine A, Sattar Naveed, McConnachie Alex, Lean Michael E J, Blane David N
Human Nutrition, School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.
School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
Nat Med. 2025 Jan;31(1):258-266. doi: 10.1038/s41591-024-03384-x. Epub 2025 Jan 8.
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 (>25 kg m 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 .
长期新冠（LC）是一种复杂的多症状疾病，目前尚无已知的疾病改善治疗方法。这项等待名单对照的开放标签试验测试了远程提供的结构化体重管理计划是否能改善超重的长期新冠患者的相应症状。患有长期新冠（症状持续超过12周）且体重指数>27 kg/m²（南亚人为>25 kg/m²）的成年人被随机分组（n = 234，1:1），分为对照组（n = 116，常规护理）或远程提供的结构化体重管理组（n = 118，每天进行850千卡的全代餐12周，随后重新引入食物并提供体重减轻维持支持），通过最小化和随机化（80:20）来平衡各组之间主要的长期新冠症状、性别、年龄、种族和基于邮政编码的多重贫困指数。对照组在6个月后接受干预。参与者选择他们最希望改善的主要长期新冠症状（疲劳、呼吸急促、疼痛、焦虑/抑郁或其他）作为预先指定的各自主要结局。对于没有预先指定量表的个体症状，使用经过验证的问卷和视觉模拟量表进行评估。在6个月时，与对照组（分析n = 117，变化-0.83（标准差1.14））相比，干预组（分析n = 97，变化-1.16（标准差1.42））的主要结局有所改善，治疗效果为-0.34（95%置信区间-0.67至-0.01），且严重不良事件无增加。国际标准随机对照试验编号注册：ISRCTN 12595520 。
