<p>Long COVID (LC) is a complex multisymptom condition with no known disease-modifying treatments. This wait-list-controlled open-label trial tested whether a remotely delivered structured weight management program could improve respective LC symptoms in people living with overweight. Adults with LC (symptoms &gt;12 weeks) and body mass index &gt;27 kg m<sup>−2</sup> (&gt;25 kg m<sup>−2</sup> for South Asians) were randomized (<i>n</i> = 234, 1:1) to control (<i>n</i> = 116, usual care) or the remotely delivered structured weight management (<i>n</i> = 118, total diet replacement (850 kcal per day) for 12 weeks, followed by food reintroduction and weight loss maintenance support) via minimization and randomization (80:20) to balance dominant LC symptom, sex, age, ethnicity and postcode-based index of multiple deprivation between groups. The control group received the intervention after 6 months. Participants selected the dominant LC symptom they would most like to improve (fatigue, breathlessness, pain, anxiety/depression or other) as the prespecified respective primary outcome. Individual symptoms were assessed using validated questionnaires and a visual analog scale for those without prespecified scales. At 6 months, the primary outcome improved in the intervention group (change −1.16 (s.d. 1.42), <i>n</i> = 97 analyzed) compared with the control group (change −0.83 (s.d. 1.14), <i>n</i> = 117 analyzed) with a treatment effect of −0.34 (95% confidence interval −0.67 to −0.01), with no excess of serious adverse events. International Standard Randomised Controlled Trial Number Registry registration: ISRCTN<a href="https://doi.org/10.1186/ISRCTN12595520">12595520</a>.</p>

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Remotely delivered weight management for people with long COVID and overweight: the randomized wait-list-controlled ReDIRECT trial

  • Emilie Combet,
  • Laura Haag,
  • Janice Richardson,
  • Caroline E. Haig,
  • Yvonne Cunningham,
  • Heather L. Fraser,
  • Naomi Brosnahan,
  • Tracy Ibbotson,
  • Jane Ormerod,
  • Chris White,
  • Emma McIntosh,
  • Catherine A. O’Donnell,
  • Naveed Sattar,
  • Alex McConnachie,
  • Michael E. J. Lean,
  • David N. Blane

摘要

Long COVID (LC) is a complex multisymptom condition with no known disease-modifying treatments. This wait-list-controlled open-label trial tested whether a remotely delivered structured weight management program could improve respective LC symptoms in people living with overweight. Adults with LC (symptoms >12 weeks) and body mass index >27 kg m−2 (>25 kg m−2 for South Asians) were randomized (n = 234, 1:1) to control (n = 116, usual care) or the remotely delivered structured weight management (n = 118, total diet replacement (850 kcal per day) for 12 weeks, followed by food reintroduction and weight loss maintenance support) via minimization and randomization (80:20) to balance dominant LC symptom, sex, age, ethnicity and postcode-based index of multiple deprivation between groups. The control group received the intervention after 6 months. Participants selected the dominant LC symptom they would most like to improve (fatigue, breathlessness, pain, anxiety/depression or other) as the prespecified respective primary outcome. Individual symptoms were assessed using validated questionnaires and a visual analog scale for those without prespecified scales. At 6 months, the primary outcome improved in the intervention group (change −1.16 (s.d. 1.42), n = 97 analyzed) compared with the control group (change −0.83 (s.d. 1.14), n = 117 analyzed) with a treatment effect of −0.34 (95% confidence interval −0.67 to −0.01), with no excess of serious adverse events. International Standard Randomised Controlled Trial Number Registry registration: ISRCTN12595520.