Haag Laura, Richardson Janice, Cunningham Yvonne, Fraser Heather, Brosnahan Naomi, Ibbotson Tracy, Ormerod Jane, White Chris, McIntosh Emma, O'Donnell Kate, Sattar Naveed, McConnachie Alex, Lean Michael E J, Blane David N, Combet Emilie
Human Nutrition, School of Medicine, Dentistry & Nursing, University of Glasgow, Glasgow, G31 2ER, UK.
School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, G12 8TA, UK.
NIHR Open Res. 2023 Aug 3;2:57. doi: 10.3310/nihropenres.13315.2. eCollection 2022.
The Remote Diet Intervention to Reduce Long COVID Symptoms Trial (ReDIRECT) evaluates whether the digitally delivered, evidence-based, cost-effective Counterweight-Plus weight management programme improves symptoms of Long COVID in people with overweight/obesity.
Baseline randomised, non-blinded design with 240 participants allocated in a 1:1 ratio either to continue usual care or to add the remotely delivered Counterweight-Plus weight management programme, which includes a Counterweight dietitian supported delivery of 12 weeks total diet replacement, food reintroduction, and long-term weight loss maintenance. Randomisation is achieved by accessing a web-based randomisation system incorporated into the study web portal developed by a registered Clinical Trials Unit. We are using an innovative approach to outcome personalisation, with each participant selecting their most dominant Long COVID symptom as their primary outcome assessed at six months. Participants in the control arm enter the weight management programme after six months. We are recruiting participants from social media and existing networks (e.g., Long COVID Scotland groups), through newspaper advertisements and from primary care. Main inclusion criteria: people with Long COVID symptoms persisting > three months, aged 18 years or above, body mass index (BMI) above 27kg/m (>25kg/m for South Asians). The trial includes a process evaluation (involving qualitative interviews with participants and analysis of data on dose, fidelity and reach of the intervention) and economic evaluation (within-trial and long-term cost-utility analyses).
The recruitment for this study started in December 2021 and ended in July 2022. Project results are not yet available and will be shared via peer-reviewed publication once the six-months outcomes have been analysed.
Current Controlled Trials ISRCTN12595520.
远程饮食干预以减轻新冠长期症状试验（ReDIRECT）旨在评估通过数字方式提供的、基于证据且具有成本效益的Counterweight-Plus体重管理计划是否能改善超重/肥胖人群的新冠长期症状。
采用基线随机、非盲法设计，240名参与者按1:1比例分配，一组继续接受常规护理，另一组加入远程提供的Counterweight-Plus体重管理计划，该计划包括由Counterweight营养师支持的12周全代餐、食物重新引入及长期体重维持。通过访问纳入由注册临床试验单位开发的研究网站门户的基于网络的随机系统进行随机分组。我们采用创新方法实现结果个性化，让每位参与者选择其最主要的新冠长期症状作为六个月时评估的主要结果。对照组参与者在六个月后进入体重管理计划。我们通过社交媒体和现有网络（如苏格兰新冠长期症状群组）、报纸广告以及初级保健机构招募参与者。主要纳入标准：新冠长期症状持续超过三个月、年龄18岁及以上、体重指数（BMI）高于27kg/m²（南亚人高于25kg/m²）。该试验包括过程评估（对参与者进行定性访谈并分析干预剂量、保真度和覆盖范围的数据）和经济评估（试验内及长期成本效用分析）。
本研究于2021年12月开始招募，2022年7月结束。项目结果尚未可得，六个月结果分析完成后将通过同行评审出版物分享。
当前受控试验ISRCTN12595520。
