1. Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity
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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, and Salas Salvadó, Jordi
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Weight loss ,Nutrition and Dietetics ,Endocrinology, Diabetes and Metabolism ,Mediterraean diet ,COVID-19 ,PREDIMED-Plus ,clinical trial ,Clinical trial ,lockdown ,Aprimament ,Mediterranean cooking ,Clinical trials ,Weight-loss ,Cuina mediterrània ,Lockdown ,Assaigs clínics ,weight-loss ,Food Science - 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 (energyreduced 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., Instituto de Salud Carlos III (ISCIII), through the Fondo de Investigacion para la Salud (FIS) European Commission PI13/00673 PI13/00492 PI13/00272 PI13/01123 PI13/00462 PI13/00233 PI13/02184 PI13/00728 PI13/01090 PI13/01056 PI14/01722 PI14/00636 PI14/00618 PI14/00696 PI14/01206, Especial Action Project, European Research Council (ERC) European Commission 340918 2013ACUP00194, Junta de Andalucia PI0458/2013 PS0358/2016 PI0137/2018, Center for Forestry Research & Experimentation (CIEF) PROMETEO/2017/017 PROMETEO 21/2021, Department of Health of the Generalitat de Catalunya SLT006/17/00246, Spanish Government FPU 17/01925, Fundacion Francisco Soria Melguizo, ICREA under the ICREA Academia programme, Canadian Institutes of Health Research (CIHR), A European Regional Development Fund PI14/01919 PI14/00853 PI14/01374 PI14/00972 PI14/00728 PI14/01471 PI16/00473 PI16/00662 PI16/01873 PI16/01094 PI16/00501 PI16/00533 PI16/00381 PI16/00366 PI16/01522 PI16/01120 PI17/00764 PI17/01183 PI17/00855, The European Regional Development Fund PI19/00386 PI19/00309 PI19/01032 PI19/00576 PI19/00017 PI19/01226 PI19/00781 PI19/01560 PI19/01332 PI20/01802 PI20/00138 PI20/01532 PI20/00456 PI20/00339 PI20/00557 PI20/00886 PI20/01158
- Published
- 2023