Remotely-delivered weight management for people living with long COVID and overweight (ReDIRECT): a wait-list controlled randomised trial.

Problem

Long COVID is a complex multi-symptom condition that can affect people following COVID-19 infection. Risk factors for long COVID include female sex, socioeconomic disadvantage, and raised body mass index (BMI). There are no established treatments for long COVID and some of the dominant symptoms (e.g. fatigue, breathlessness, brain fog) may make engagement in research difficult. The study aimed to assess whether home-delivered weight management could improve long COVID symptoms in people living with excess weight.

Approach

ReDIRECT was a randomised, wait-list-controlled trial (ISRCTN:12595520) in participants with long COVID and body-mass index >27kg/m2 (>25 kg/m2 for South Asians) recruited across the UK. The intervention comprised remotely-delivered structured weight management (formula total diet replacement (850 kcal/d), or an alternative if not tolerated) and behaviour change guidance for 12 weeks, followed by food reintroduction and weight loss maintenance support for one year. Trained dietitians provided personalised phone/video or text support, in-app weekly monitoring and nudges, and peer-group support.We pre-specified a personalised primary outcome: participants selected the major long COVID symptom they most wanted improved, from Fatigue, Breathlessness, Pain, Anxiety/Depression, and Other, assessed using validated questionnaires and VAS scales at baseline and 6 months.Secondary outcomes included changes in weight, blood pressure, health-related quality of life (EQ5D), and specific major long COVID symptoms at 3 and 6 months. The study was funded by the National Institute for Health and Care Research (NIHR). Trial registration no. ISRCTN:12595520Patient and Public Involvement: People living with long COVID were involved throughout, including a PPI lead and PPI co-investigator. The novel personalised primary endpoint was also informed by our PPI collaborators.

Findings

Between 23 December 2021 and 04 July 2023, 234 participants were randomly assigned to intervention (n=116) or waitlist control (n=118) groups. The groups were well matched for sex (84% women), ethnicity (90% white), age (mean 46 years), BMI (median 35 (32-40) kg/m2) medications and symptom distribution. The intervention improved the primary outcome (patient-selected long COVID symptom) with a mean between-group difference of -0.34 [95% CI -0.67, -0.01, p=0.047] at 6 months. Mean weight change in the intervention group was -10.3 (SD 7.5) kg at 6 months, compared to -0.7 (SD 5.2) kg in the control group. The intervention improved Fatigue (treatment effect of -3.46 [95%CI -5.42, -1.86], p<0.0001), Breathlessness (-0.27 [95%CI -0.48, -0.06], p=0.0124), Anxiety/Depression (-1.94 [95%CI -3.64, -0.25], p=0.0249) and Other symptoms (-1.13 [95%CI -1.82, -0.44], p=0.0016) vs. control group at 6 months, but not Pain. The intervention improved blood pressure and health-related quality of life, with no excess of adverse events.

Consequences

Entirely remotely delivered weight management was safe and effective at reducing long COVID symptoms that matter most to people living with long COVID and excess weight.