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Title: Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity
Author: Paz Graniel, Indira
Colomer, Montserrat
Ros Rahola, Emilio
Buil Cosiales, Pilar
Corella Piquer, Dolores
Babio, Nancy
Martínez, J. Alfredo, 1957-
Alonso Gómez, Ángel M.
Wärnberg, Julia
Vioque, Jesús
Romaguera, Dora
López Miranda, José
Estruch Riba, Ramon
Tinahones, Francisco J.
Lapetra, José
Serra Majem, Lluís
Bueno Cavanillas, Aurora
Tur, Josep A.
Martín Sánchez, Vicente
Pintó Sala, Xavier
Gaforio, José J.
Matía Martín, Pilar
Vidal i Cortada, Josep
Vázquez, Clotilde
Daimiel, Lidia
García Gavilán, Jesús
Toledo Atucha, Estefanía
Nishi, Stephanie K.
Sorlí, José V.
Castañer, Olga
García Ríos, Antonio
García de la Hera, Manuela
Barón López, Francisco Javier
Ruiz Canela, Miguel
Morey, Marga
Casas Rodríguez, Rosa M.
Garrido Aguilar, Eva María
Tojal Sierra, Lucas
Fernández García, José C.
Vázquez Ruiz, Zenaida
Fernández Carrión, Rebeca
Goday Arnó, Albert
Peña Orihuela, Patricia J.
Compañ Gabucio, Laura
Schröder, Helmut, 1958-
Martínez-González, Miguel Ángel, 1957-
Salas Salvadó, Jordi
Keywords: COVID-19
Cuina mediterrània
Assaigs clínics
Mediterranean cooking
Clinical trials
Weight loss
Issue Date: 12-Jan-2023
Publisher: Frontiers Media
Abstract: Background: The 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. Methods: We 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. Results: During 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]). Conclusion: Mitigating 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 registration:, identifier ISRCTN89898870. Keywords: COVID-19; Mediterraean diet; PREDIMED-Plus; clinical trial; lockdown; weight-loss. Copyright © 2023 Paz-Graniel, Fitó, Ros, Buil-Cosiales, Corella, Babio, Martínez, Alonso-Gómez, Wärnberg, Vioque, Romaguera, López-Miranda, Estruch, Tinahones, Lapetra, Serra-Majem, Bueno-Cavanillas, Tur, Martín-Sánchez, Pintó, Gaforio, Matía-Martín, Vidal, Vázquez, Daimiel, García-Gavilán, Toledo, Nishi, Sorlí, Castañer, García-Ríos, García de la Hera, Barón-López, Ruiz-Canela, Morey, Casas, Garrido-Garrido, Tojal-Sierra, Fernández-García, Vázquez-Ruiz, Fernández-Carrión, Goday, Peña-Orihuela, Compañ-Gabucio, Schröder, Martínez-Gonzalez and Salas-Salvadó. Conflict of interest statement The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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It is part of: Frontiers In Nutrition, 2023, vol. 9, p. 1098269
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ISSN: 2296-861X
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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