Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity
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...
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Frontiers Media S.A.
2023-01-01
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| Series: | Frontiers in Nutrition |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnut.2022.1098269/full |
| _version_ | 1828066471866007552 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Indira Paz-Graniel |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T23:32:16Z |
| format | Article |
| id | doaj.art-e0e483c5a3dc4e558873bad6ea570d40 |
| institution | Directory Open Access Journal |
| issn | 2296-861X |
| language | English |
| last_indexed | 2024-04-10T23:32:16Z |
| publishDate | 2023-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Nutrition |
| spelling | doaj.art-e0e483c5a3dc4e558873bad6ea570d402023-01-12T05:54:19ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2023-01-01910.3389/fnut.2022.10982691098269Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposityIndira Paz-Graniel0Indira Paz-Graniel1Indira Paz-Graniel2Montserrat Fitó3Montserrat Fitó4Emilio Ros5Emilio Ros6Pilar Buil-Cosiales7Pilar Buil-Cosiales8Dolores Corella9Dolores Corella10Nancy Babio11Nancy Babio12Nancy Babio13J. Alfredo Martínez14J. Alfredo Martínez15J. Alfredo Martínez16Ángel M. Alonso-Gómez17Ángel M. Alonso-Gómez18Julia Wärnberg19Julia Wärnberg20Jesús Vioque21Jesús Vioque22Dora Romaguera23Dora Romaguera24José López-Miranda25José López-Miranda26Ramon Estruch27Ramon Estruch28Francisco J. Tinahones29Francisco J. Tinahones30José Lapetra31José Lapetra32Lluis Serra-Majem33Lluis Serra-Majem34Aurora Bueno-Cavanillas35Aurora Bueno-Cavanillas36Josep A. Tur37Josep A. Tur38Vicente Martín-Sánchez39Vicente Martín-Sánchez40Xavier Pintó41Xavier Pintó42José Juan Gaforio43José Juan Gaforio44Pilar Matía-Martín45Pilar Matía-Martín46Josep Vidal47Josep Vidal48Clotilde Vázquez49Clotilde Vázquez50Lidia Daimiel51Lidia Daimiel52Jesus F. García-Gavilán53Jesus F. García-Gavilán54Jesus F. García-Gavilán55Estefanía Toledo56Estefanía Toledo57Stephanie K. Nishi58Stephanie K. Nishi59Stephanie K. Nishi60Stephanie K. Nishi61Stephanie K. Nishi62Jose V. Sorlí63Jose V. Sorlí64Olga Castañer65Olga Castañer66Antonio García-Ríos67Antonio García-Ríos68Manoli García de la Hera69Manoli García de la Hera70Francisco Javier Barón-López71Francisco Javier Barón-López72Miguel Ruiz-Canela73Miguel Ruiz-Canela74Marga Morey75Marga Morey76Rosa Casas77Rosa Casas78Eva María Garrido-Garrido79Lucas Tojal-Sierra80Lucas Tojal-Sierra81José C. Fernández-García82José C. Fernández-García83Zenaida Vázquez-Ruiz84Zenaida Vázquez-Ruiz85Rebeca Fernández-Carrión86Rebeca Fernández-Carrión87Albert Goday88Albert Goday89Patricia J. Peña-Orihuela90Patricia J. Peña-Orihuela91Laura Compañ-Gabucio92Laura Compañ-Gabucio93Helmut Schröder94Helmut Schröder95Miguel A. Martínez-Gonzalez96Miguel A. Martínez-Gonzalez97Miguel A. Martínez-Gonzalez98Jordi Salas-Salvadó99Jordi Salas-Salvadó100Jordi Salas-Salvadó101Consorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUniversitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, SpainInstitut d’Investigació Sanitària Pere Virgili (IISPV), Reus, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUnit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d‘Investigació Médica (IMIM), Barcelona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainLipid Clinic, Department of Endocrinology and Nutrition, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clínic, Barcelona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainPrimary Health Care, IdiSNA, Servicio Navarro de Salud, Pamplona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainSchool of Medicine, Department of Preventive Medicine and Public Health, University of Valencia, Valencia, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUniversitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, SpainInstitut d’Investigació Sanitària Pere Virgili (IISPV), Reus, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainDepartment of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, Pamplona, SpainPrecision Nutrition and Cardiometabolic Health Program, IMDEA Food, CEI UAM + CSIC, Madrid, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain0Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain1EpiPHAAN Research Group, School of Health Sciences, Instituto de Investigación Biomédica en Málaga (IBIMA), University of Málaga, Málaga, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, España3Instituto de Investigación Sanitaria y Biomédica de Alicante, Universidad Miguel Hernández (ISABIAL-UMH), Alicante, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain4Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain5Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Córdoba, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain6Department of Internal Medicine, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain7Department of Endocrinology, Instituto de Investigación Biomédica de Málaga (IBIMA), Virgen de la Victoria Hospital, University of Málaga, Málaga, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain8Research Unit, Department of Family Medicine, Distrito Sanitario Atención Primaria Seville, Seville, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain9Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria and Centro Hospitalario Universitario Insular Materno Infantil (CHUIMI), Canarian Health Service, Las Palmas, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, España0Department of Preventive Medicine and Public Health, University of Granada, Granada, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain1Research Group on Community Nutrition and Oxidative Stress, University of Balearic Islands, Palma de Mallorca, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, España2Institute of Biomedicine (IBIOMED), University of León, León, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain3Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge-Idibell, Hospitalet de Llobregat, Universitat de Barcelona, Barcelona, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, España4Departamento de Ciencias de la Salud, Instituto Universitario de Investigación en Olivar y Aceites de Oliva, Universidad de Jaén, Jaén, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain5Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Universidad Complutense, Madrid, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain6Department of Endocrinology, Institut d’Investigacions Biomédiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain7Department of Endocrinology and Nutrition, Hospital Fundación Jimenez Díaz, Instituto de Investigaciones Biomédicas IISFJD, University Autonoma, Madrid, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain8Nutritional Control of the Epigenome Group, Precision Nutrition and Obesity Program, IMDEA Food, CEI UAM + CSIC, Madrid, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUniversitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, SpainInstitut d’Investigació Sanitària Pere Virgili (IISPV), Reus, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain9Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, Pamplona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUniversitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, SpainInstitut d’Investigació Sanitària Pere Virgili (IISPV), Reus, Spain0Toronto 3D (Diet, Digestive Tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Toronto, ON, Canada1Clinical Nutrition and Risk Factor Modification Centre, St. Michael’s Hospital, Unity Health Toronto, ON, CanadaConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainSchool of Medicine, Department of Preventive Medicine and Public Health, University of Valencia, Valencia, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUnit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d‘Investigació Médica (IMIM), Barcelona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain5Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, España3Instituto de Investigación Sanitaria y Biomédica de Alicante, Universidad Miguel Hernández (ISABIAL-UMH), Alicante, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain1EpiPHAAN Research Group, School of Health Sciences, Instituto de Investigación Biomédica en Málaga (IBIMA), University of Málaga, Málaga, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain9Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, Pamplona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain4Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain6Department of Internal Medicine, Institut d’Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain2Primary Care Center Zaidín-Center, Andalusian Health Service, Granada, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain0Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba University Hospital, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain7Department of Endocrinology, Instituto de Investigación Biomédica de Málaga (IBIMA), Virgen de la Victoria Hospital, University of Málaga, Málaga, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain9Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, Pamplona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainSchool of Medicine, Department of Preventive Medicine and Public Health, University of Valencia, Valencia, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUnit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d‘Investigació Médica (IMIM), Barcelona, SpainConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain5Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, España3Instituto de Investigación Sanitaria y Biomédica de Alicante, Universidad Miguel Hernández (ISABIAL-UMH), Alicante, SpainUnit of Cardiovascular Risk and Nutrition, Institut Hospital del Mar de Investigaciones Médicas Municipal d‘Investigació Médica (IMIM), Barcelona, Spain2Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, EspañaConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, Spain9Department of Preventive Medicine and Public Health, IDISNA, University of Navarra, Pamplona, Spain3Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, United StatesConsorcio CIBER, Fisiopatología de la Obesidad y Nutrición (CIBERObn), Institute of Health Carlos III, Madrid, SpainUniversitat Rovira i Virgili, Departament de Bioquímica i Biotecnologia, Unitat de Nutrició, Reus, SpainInstitut d’Investigació Sanitària Pere Virgili (IISPV), Reus, SpainBackgroundThe 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.https://www.frontiersin.org/articles/10.3389/fnut.2022.1098269/fullCOVID-19PREDIMED-Pluslockdownclinical trialweight-lossMediterraean diet |
| spellingShingle | 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 Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity Frontiers in Nutrition COVID-19 PREDIMED-Plus lockdown clinical trial weight-loss Mediterraean diet |
| title | Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity |
| title_full | Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity |
| title_fullStr | Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity |
| title_full_unstemmed | Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity |
| title_short | Impact of COVID-19 pandemic on the PREDIMED-Plus randomized clinical trial: Effects on the interventions, participants follow-up, and adiposity |
| title_sort | impact of covid 19 pandemic on the predimed plus randomized clinical trial effects on the interventions participants follow up and adiposity |
| topic | COVID-19 PREDIMED-Plus lockdown clinical trial weight-loss Mediterraean diet |
| url | https://www.frontiersin.org/articles/10.3389/fnut.2022.1098269/full |
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