How do participants experience the work involved in the Remote Diet Intervention to REduce long-COVID symptoms Trial (ReDIRECT)?
Problem
Long COVID (LC), a new condition, is the persistence of symptoms for ≥12 weeks after a COVID-19 infection. The pathophysiology of LC is complex and symptom improvement remains a critical treatment target for individuals. Persistent inflammation is one proposed mechanism underpinning LC and excess adiposity is an established risk factor.The aim of the study is to evaluate whether the digitally delivered, evidence-based, Counterweight-Plus weight management programme improves symptoms of LC in people living with overweight/obesity. Here we present the qualitative component of the process evaluation.
Approach
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 weight management programme (Counterweight-Plus), including a dietitian-supported delivery of 12 weeks total diet replacement, followed by food reintroduction/weight loss maintenance (months 3-12). All aspects of the study are delivered remotely.We are using an innovative approach to outcome personalisation, with each participant selecting their most dominant LC symptom as their primary outcome assessed at six months after randomisation. Participants in the control arm enter the weight management programme six months after the intervention group.Process evaluation included qualitative methods to understand how the intervention was implemented and experienced. Semi-structured interviews were conducted at baseline (n=31) and at 6 months post randomization (n=16).Interviews focused on patient expectations, motivations, experiences of the intervention, impact on LC symptoms, and contextual factors that affect (and may be affected by) implementation, intervention mechanisms and outcomes.Analysis drew on Normalisation Process Theory (NPT) and Burden of Treatment Theory (BOTT) which focuses on the balance between ‘work’ (e.g. tasks of self-care or tasks given to patients by health care professionals), and ‘capacity’ (e.g. physical, mental, financial, or social ability) to perform these tasks.
Findings
Participants reported that the fully remote delivery, without any in-person study visits was helpful, as was simplified meal planning and decision-making, the offer of alternative options (e.g. low-fat, or low-carb), and being able to focus on diet without a requirement for exercise, as many were living with fatigue and/or post-exertional malaise. Interviewees reported more difficulty with the work involved in participating in the intervention at the food re-introduction phase. Using the BOTT framework, symptoms such as fatigue, post-exertional malaise and brain fog created a mismatch between the ‘work’ required to engage with the intervention and the ‘capacity’ of participants to do so.
Consequences
These findings could help us to design future interventions for other long-term conditions characterised by fatigue (such as CFS/ME). We have also learned transferrable lessons related to the fully remote delivery of this weight management intervention.