Protocol The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT) [...], 2023, Haag et al

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

Laura Haag, Janice Richardson, Yvonne Cunningham, Heather Fraser, Naomi Brosnahan, Tracy Ibbotson, Jane Ormerod, Chris White, Emma McIntosh, Kate O'Donnell, Naveed Sattar, Alex McConnachie, Michael E J Lean, David N Blane, Emilie Combet

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/m 2 (>25kg/m 2 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.



Plain language summary
While most people infected with COVID-19 recover within a short amount of time, some people continue to have symptoms for 12 weeks or longer. This condition is known as Long COVID. Roughly two-thirds of people with Long COVID are overweight, a proportion similar to that found in the general population. Being overweight may worsen symptoms such as fatigue, breathlessness and pains. Weight management programmes in adults with overweight/obesity can reduce such symptoms, however we do not know how effective intentional weight loss is to reduce symptoms for people with Long COVID. The aim of this project is to test a well-established weight management programme, delivered and supported remotely, in people with Long COVID.

The trial is conducted with 240 people with Long COVID, identified through their GP, patient groups, social media, or newspaper advertisements. A total of 120 individuals will receive the personalised, professionally supported weight management programme (treatment group), and 120 participants are allocated to usual care (control group). The one-year long weight management programme involves 12 weeks of total diet replacement (TDR) using soups and shakes, followed by food reintroduction and weight maintenance. Food based alternatives are available to those who are unable, or prefer not to, follow the TDR approach. The two groups will be compared for Long COVID symptoms, weight loss, quality of life and value for money after six months. After six months, the weight management programme will also be provided for the control group. Experiences while on the programme will be documented for 12 months for all participants.

People with Long COVID have been involved extensively in developing this project. Their priorities are to reduce symptoms like fatigue, breathlessness and pain. They are keen to explore if effective weight management would help their symptoms and overall functioning, especially a programme that can be followed remotely from home. A group of patients and other stakeholders has been set up to provide advice throughout the project.

Conflict of interest statement
Competing interests: AM is a member of Clinical Steering Committee for ARC Medical Inc. NS has received institutional grant support from AstraZeneca, Boehringer Ingelheim, Novartis, Roche Diagnostics and honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Sanofi ML has consulted for Novo Nordisk, Nestle, Oviva, Merck, Sanofi and is an unpaid medical advisor to Counterweight Ltd. NB is an employee and shareholder of Counterweight Ltd., subcontracted to the University of Glasgow to deliver the ReDIRECT intervention

Full text (PubMed Central) | Trial registration

 

Registration page says the study ended on 31 May 2024, and they intend to publish on 1 November 2024.

 

Previous trial studying this intervention in diabetes:

Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial, 2017, Lean et al

Link (The Lancet) [Paywall]

 

Hmm -

So, rate of being overweight is the same as the general population.

Losing weight may help some non-ME LC sufferers but this isn't a healthy diet. Surely meal replacements are the epitome of ultra-processed foods, about which there's much concern. Also replacing a normal diet in this way doesn't help people to learn healthy eating patterns.

No mention of pwLC struggling to buy and prepare food, difficulties with digestion, new food intolerances or allergies.

 

The meal replacement stage is only the first 8-12 weeks, then a 4-12 week transition into a full-food diet, which will be eaten the rest of the six months (~0-12 weeks). A counselor will help them maintain a healthy diet. And outcomes will be measured at 12 months.