The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT): protocol for a randomised controlled trial to determine the effectiveness and cost-effectiveness of a remotely delivered supported weight management programme for people with Long COVID and excess weight, with personalised improvement goals

Haag, L. et al. (2022) The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT): protocol for a randomised controlled trial to determine the effectiveness and cost-effectiveness of a remotely delivered supported weight management programme for people with Long COVID and excess weight, with personalised improvement goals. NIHR Open Research, 2, 57. (doi: 10.3310/nihropenres.13315.1)

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Abstract

Objectives: 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. Methods: 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/m2 (>25kg/m2 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). Anticipated results: 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. Trial registration: Current Controlled Trials ISRCTN12595520

Item Type:Articles
Additional Information:Version 1; peer review: awaiting peer review. The study is funded through an award from the National Institute for Health and Care Research (NIHR) to the University of Glasgow following peer review with the award reference number COV-LT2-0059. Counterweight Ltd, sub-contracted to the University of Glasgow, is the study intervention provider.
Status:Published
Refereed:No
Glasgow Author(s) Enlighten ID:Blane, Dr David and McConnachie, Professor Alex and Brosnahan, Dr Naomi and Cunningham, Dr Yvonne and Ormerod, Mrs Jane and Lean, Professor Michael and Richardson, Mrs Janice and Combet Aspray, Professor Emilie and Ibbotson, Dr Tracy and Haag, Ms Laura and White, Mr Christopher and Sattar, Professor Naveed and O'Donnell, Professor Kate and Fraser, Miss Heather
Authors: Haag, L., Richardson, J., Cunningham, Y., Fraser, H., Brosnahan, N., Ibbotson, T., Ormerod, J., White, C., O'Donnell, K., Sattar, N., McConnachie, A., Lean, M. E. J., Blane, D. N., and Combet, E.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care
College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:NIHR Open Research
Publisher:F1000Research
ISSN:2633-4402
ISSN (Online):2633-4402
Published Online:24 November 2022
Copyright Holders:Copyright © 2022 Haag L et al
First Published:First published in NIHR Open Research 2: 7
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
315071REDIRECT: REmote Diet Intervention to REduce long Covid symptoms TrialDavid BlaneNational Institute for Health Research (NIHR)COV-LT2-0059HW - Health Economics and Health Technology Assessment