Title: ReDIRECT: Remote Diet Intervention to REduce long Covid symptoms Trial
Funder: Department of Health and Social Care

Abstract: We propose a randomised controlled trial of a readily-transferable programme to reduce symptom-burden in people with Long COVID and overweight/obesity, generating results within 16 months. We will use the leading dietary weight management programme (Counterweight-Plus), shown to be safe and cost-effective in achieving and sustaining mean weight loss >10kg and remission of type-2 diabetes (DiReCT trial), delivered entirely remotely with professional personal support to people at home. We will use an innovative approach to personalisation, each participant selecting their most dominant symptom as primary outcome. Around 10% of people infected with COVID-19 experience persistent symptoms for 12 weeks or longer ( Long COVID ). There are strong, likely causal, links between overweight/obesity and severity of COVID-19, and many (~70%) with Long COVID have overweight/obesity, similar to other UK adults. An inflammatory mechanism has been proposed to mediate aspects of Long COVID, aggravated by overweight/obesity. Some of the commonest symptoms (fatigue, breathlessness, pains) are also common with overweight/obesity, and helped by weight loss. However, robust trial data are needed to establish the impact of weight loss on Long COVID symptoms, and interventions must suit people whose symptoms impair mobility and ability to attend external appointments. WP1 (PPI / stakeholder engagement) will streamline a recruitment strategy and implementation plan to maximise engagement and impact, co-designed with people living with Long COVID, health care practitioners, and the online Counterweight-Plus/DiRECT weight management programme. WP2 (Randomised Controlled Trial) will evaluate whether the online weight management intervention improves primary symptoms of Long COVID, and wider health and psychological outcomes, vs standard care. WP3 (Process evaluation) will identify barriers and facilitators to delivery, explore the experience of participants, and test hypothesised mechanisms of action. WP4 (Economic evaluation) will evaluate within-trial cost-effectiveness of the intervention, model long-term cost implications, and assess cost-effectiveness across demographic groups and impact on health inequalities.

Lay abstract: WHY THIS RESEARCH IS IMPORTANT Around 10% of people infected with COVID-19 have symptoms for 12 weeks or longer (Long COVID). People with Long COVID also have overweight/obesity to a similar extent than the rest of the population (~70%), which may worsen their symptoms. Weight management programmes in adults with overweight /obesity can reduce symptoms such as fatigue, breathlessness and pains, also common with Long COVID. 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 entirely remotely, in people with Long COVID. OUR PLAN 1. We will adapt an established weight management programme and its evaluation for people with Long COVID, through stakeholder workshops with patients, carers and staff. 2. A trial will be conducted with 200 people with Long COVID, identified through their GP, patient groups or social media. We will allocate 100 individuals to receive the personalised, professionally-supported weight management programme, 100 to usual care, and compare Long COVID symptoms, weight loss, quality of life and value for money after 6 months. After 6 months, the intervention will be provided for the control group. Experiences will be documented for 12 months. INVOLVEMENT OF PATIENTS AND STAKEHOLDERS 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 will provide advice throughout the project. SHARING OUR FINDINGS We will use our relationships with patient organisations, stakeholders and the research community to share findings using traditional and social media.

Research activity codes: 5.7 PHYSICAL;6.7 PHYSICAL
Health categories: INFECTION