Frontiers in Nutrition (Jan 2023)

Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity

  • Indira Paz-Graniel,
  • Indira Paz-Graniel,
  • Indira Paz-Graniel,
  • Montserrat Fitó,
  • Montserrat Fitó,
  • Emilio Ros,
  • Emilio Ros,
  • Pilar Buil-Cosiales,
  • Pilar Buil-Cosiales,
  • Dolores Corella,
  • Dolores Corella,
  • Nancy Babio,
  • Nancy Babio,
  • Nancy Babio,
  • J. Alfredo Martínez,
  • J. Alfredo Martínez,
  • J. Alfredo Martínez,
  • Ángel M. Alonso-Gómez,
  • Ángel M. Alonso-Gómez,
  • Julia Wärnberg,
  • Julia Wärnberg,
  • Jesús Vioque,
  • Jesús Vioque,
  • Dora Romaguera,
  • Dora Romaguera,
  • José López-Miranda,
  • José López-Miranda,
  • Ramon Estruch,
  • Ramon Estruch,
  • Francisco J. Tinahones,
  • Francisco J. Tinahones,
  • José Lapetra,
  • José Lapetra,
  • Lluis Serra-Majem,
  • Lluis Serra-Majem,
  • Aurora Bueno-Cavanillas,
  • Aurora Bueno-Cavanillas,
  • Josep A. Tur,
  • Josep A. Tur,
  • Vicente Martín-Sánchez,
  • Vicente Martín-Sánchez,
  • Xavier Pintó,
  • Xavier Pintó,
  • José Juan Gaforio,
  • José Juan Gaforio,
  • Pilar Matía-Martín,
  • Pilar Matía-Martín,
  • Josep Vidal,
  • Josep Vidal,
  • Clotilde Vázquez,
  • Clotilde Vázquez,
  • Lidia Daimiel,
  • Lidia Daimiel,
  • Jesus F. García-Gavilán,
  • Jesus F. García-Gavilán,
  • Jesus F. García-Gavilán,
  • Estefanía Toledo,
  • Estefanía Toledo,
  • Stephanie K. Nishi,
  • Stephanie K. Nishi,
  • Stephanie K. Nishi,
  • Stephanie K. Nishi,
  • Stephanie K. Nishi,
  • Jose V. Sorlí,
  • Jose V. Sorlí,
  • Olga Castañer,
  • Olga Castañer,
  • Antonio García-Ríos,
  • Antonio García-Ríos,
  • Manoli García de la Hera,
  • Manoli García de la Hera,
  • Francisco Javier Barón-López,
  • Francisco Javier Barón-López,
  • Miguel Ruiz-Canela,
  • Miguel Ruiz-Canela,
  • Marga Morey,
  • Marga Morey,
  • Rosa Casas,
  • Rosa Casas,
  • Eva María Garrido-Garrido,
  • Lucas Tojal-Sierra,
  • Lucas Tojal-Sierra,
  • José C. Fernández-García,
  • José C. Fernández-García,
  • Zenaida Vázquez-Ruiz,
  • Zenaida Vázquez-Ruiz,
  • Rebeca Fernández-Carrión,
  • Rebeca Fernández-Carrión,
  • Albert Goday,
  • Albert Goday,
  • Patricia J. Peña-Orihuela,
  • Patricia J. Peña-Orihuela,
  • Laura Compañ-Gabucio,
  • Laura Compañ-Gabucio,
  • Helmut Schröder,
  • Helmut Schröder,
  • Miguel A. Martínez-Gonzalez,
  • Miguel A. Martínez-Gonzalez,
  • Miguel A. Martínez-Gonzalez,
  • Jordi Salas-Salvadó,
  • Jordi Salas-Salvadó,
  • Jordi Salas-Salvadó

DOI
https://doi.org/10.3389/fnut.2022.1098269
Journal volume & issue
Vol. 9

Abstract

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BackgroundThe COVID-19 pandemic has affected the implementation of most ongoing clinical trials worldwide including the PREDIMED-Plus study. The PREDIMED-Plus is an ongoing, multicenter, controlled intervention trial, aimed at weight-loss and cardiovascular disease prevention, in which participants were randomized (1:1 ratio) to an intervention group (energy-reduced Mediterranean diet, promotion of physical activity, and behavioral support) or to a control group (Mediterranean diet with usual care advice). When the pandemic began, the trial was in the midst of the planned intervention. The objective of this report was to examine the effects of the pandemic on the delivery of the intervention and to describe the strategies established to mitigate the possible adverse effects of the pandemic lockdown on data collection and adiposity.MethodsWe assessed the integrity of the PREDIMED-Plus trial during 5 identified periods of the COVID-19 pandemic determined according to restrictions dictated by the Spanish government authorities. A standardized questionnaire was delivered to each of the 23 PREDIMED-Plus recruiting centers to collected data regarding the trial integrity. The effect of the restrictions on intervention components (diet, physical activity) was evaluated with data obtained in the three identified lockdown phases: pre lockdown, lockdown proper, and post lockdown.ResultsDuring the lockdown (March/2020-June/2021), 4,612 participants (48% women, mean age 65y) attended pre-specified yearly follow-up visits to receive lifestyle recommendations and obtain adiposity measures. The overall mean (SD) of the proportions reported by each center showed that 40.4% (25.4) participants had in-person visits, 39.8% (18.2) participants were contacted by telephone and 35% (26.3) by electronic means. Participants’ follow-up and data collection rates increased across lockdown periods (from ≈10% at onset to ≈80% at the end). Compared to pre-lockdown, waist circumference increased during (0.75 cm [95% CI: 0.60–0.91]) and after (0.72 cm [95% CI: 0.56–0.89]) lockdown. Body weight did not change during lockdown (0.01 kg [95% CI: –0.10 to 0.13) and decreased after lockdown (-0.17 kg [95% CI: –0.30 to –0.04]).ConclusionMitigating strategies to enforce the intervention and patient’s follow-up during lockdown have been successful in preserving the integrity of the trial and ensuring its continuation, with minor effects on adiposity.Clinical trial registrationhttps://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

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