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

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: https://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

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

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 https://doi.org/10.1186/ISRCTN89898870, identifier ISRCTN89898870.

Patients Undergoing Bariatric Surgery: a Special Risk Group for Lifestyle, Emotional and Behavioral Adaptations During the COVID-19 Lockdown. Lessons from the First Wave.

OBJECTIVES: To determine how the COVID-19 lockdown influenced the lifestyle, eating behavior, use of substances, mental health, and weight in patients who had undergone bariatric surgery (BS) and explore the self-perception of one's own health and fears related to COVID-19. METHODS: We performed a cross-sectional exploratory study in obesity patients who had undergone BS surgery > 1 year previously in a university hospital. Assessment was performed 40 days after initiating lockdown and included 2 periods: from April 24 until May 8 and during the initial de-escalation period: from May 9 until 22, 2020. A structured telephone interview and an online survey were administered. RESULTS: One hundred eighty-eight patients were interviewed; 156 also responded to the online survey (77% females, mean age 53.46 ± 10.48 years, mean follow-up 5.71 ± 4.30 years). Dietary habits were affected in 72% of the participants, with 15% reporting better diet planning; 83.5% reported having more sedentary behaviors; 27% and 36% showed depression and anxiety, respectively; and 45% of participants reported bad sleep quality. In relation to changes in the use of any substance, the use increased in the majority of patients who were previously users. Self-perception of one's own health and fears related to COVID-19 were only moderate. Finally, emotional eating and time since BS were statistically significant risk factors for predicting weight gain. CONCLUSIONS: Lockdown during COVID-19 pandemic negatively influenced the lifestyle, mental health, substance use, and weight in BS patients. These alterations were somewhat similar to those observed in the general population but more severe and with important clinical implications.

Administration and State in the post Covid-19 context: Towards a new type of bond?.

The Covid-19 pandemic has had profound impacts on all societies. The State and the Administration have not been left out but are in an environment characterized by dynamic changes and contingent. The changes initiated a few years before on the function and extension of the State have been accentuated, and the administrations will have to adapt to very unstable conditions: changes in the economy and political actors, rapid reformulation of methods, new demands, relationship with the society. Two central questions appear in this scenario. The first one is descriptive in nature, about the transformation of the State and the Public Administration in an insecure, complex and contingent environment. In the second of a methodological-conceptual nature, there is a need to seek and apply concepts and logics capable of interdisciplinary dialogue and with sufficient suitability and sophistication to describe this complexity. (English) [ABSTRACT FROM AUTHOR] La pandemia de Covid-19 ha tenido profundos impactos en todas las sociedades. El Estado y la Administración no han quedado al margen sino que se encuentran en un entorno caracterizado por cambios dinámicos, desconocidos y contingentes. Las transformaciones iniciadas unos años antes sobre la función y extensión del Estado se han acentuado, y las administraciones tendrán que adaptarse a unas condiciones muy inestables: cambios en la economía y de los actores políticos, reformulación rápida de métodos, nuevas demandas, reformulación de la relación con la sociedad. En este escenario aparecen dos cuestiones centrales. Una primera de carácter descriptivo, sobre la transformación del Estado y la administración en un entorno inseguro, complejo y contingente. En la segunda de índole metodológicoconceptual, aparece la necesidad de procurar y aplicar conceptos y lógicas con capacidad del diálogo interdisciplinario y con la suficiente idoneidad y sofisticación para describir esta complejidad. (Spanish) [ABSTRACT FROM AUTHOR] Copyright of Gestión y Análisis de Políticas Públicas, Nueva Época (GAPP) is the property of Instituto Nacional de Administracion Publica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Psychosocial, Lifestyle, and Body Weight Impact of COVID-19-Related Lockdown in a Sample of Participants with Current or Past History of Obesity in Spain.

PURPOSE: Home lockdown and isolation due to COVID-19 have been related to negative changes in mood, sleep, and eating behaviors. People with obesity are especially vulnerable to emotional eating and might be more prone to weight gain and negative outcomes during lockdown. MATERIALS AND METHODS: Individuals scheduled for an appointment at the Obesity Unit of a Tertiary Hospital between March 16 and June 21 (n=1230). An online survey was distributed on May 11. Multivariable logistic regression models and general linear models were used to assess the relationship between perceived COVID-19 threat, BS status, and outcome variables. RESULTS: Of the 603 (72.0% females, 39% aged >55 years) respondents, 223 (36.9%) were BS naïve (non-BS), 134 (22.2%) underwent BS within the two previous years (BS<2y), and 245 (40.6%) more than 2 years before (BS>2y). Participants worried about being infected by COVID-19 showed significantly larger changes in family contact (p=0.04), mood (p<0.01), sleep (p<0.01), dietary habits (p=0.05), purchases of unhealthy food (p=0.02), snacking (p=0.05), and physical activity (p=0.02). Non-BS and BS>2y participants reported greater impact of lockdown in mood (p<0.01), experienced more negative changes in dietary habits (p<0.01), and had a higher likelihood for weight gain (OR: 5.61, 95% CI: 3.0-10.46; OR: 5.45, 95% CI: 2.87-10.35, respectively) compared to BS<2y. CONCLUSIONS: COVID-19 pandemic is having a substantial negative impact in our population affected by obesity. During lockdown, people more than 2 years before BS behave like people without history of BS. Strategies addressed to prevent negative metabolic outcomes in this population are urgently needed.

Bariatric and metabolic surgery during and after the COVID-19 pandemic: DSS recommendations for management of surgical candidates and postoperative patients and prioritisation of access to surgery.

The coronavirus disease 2019 pandemic is wreaking havoc on society, especially health-care systems, including disrupting bariatric and metabolic surgery. The current limitations on accessibility to non-urgent care undermine postoperative monitoring of patients who have undergone such operations. Furthermore, like most elective surgery, new bariatric and metabolic procedures are being postponed worldwide during the pandemic. When the outbreak abates, a backlog of people seeking these operations will exist. Hence, surgical candidates face prolonged delays of beneficial treatment. Because of the progressive nature of obesity and diabetes, delaying surgery increases risks for morbidity and mortality, thus requiring strategies to mitigate harm. The risk of harm, however, varies among patients, depending on the type and severity of their comorbidities. A triaging strategy is therefore needed. The traditional weight-centric patient-selection criteria do not favour cases based on actual clinical needs. In this Personal View, experts from the Diabetes Surgery Summit consensus conference series provide guidance for the management of patients while surgery is delayed and for postoperative surveillance. We also offer a strategy to prioritise bariatric and metabolic surgery candidates on the basis of the diseases that are most likely to be ameliorated postoperatively. Although our system will be particularly germane in the immediate future, it also provides a framework for long-term clinically meaningful prioritisation.

Practical recommendations for the management of diabetes in patients with COVID-19.

Diabetes is one of the most important comorbidities linked to the severity of all three known human pathogenic coronavirus infections, including severe acute respiratory syndrome coronavirus 2. Patients with diabetes have an increased risk of severe complications including Adult Respiratory Distress Syndrome and multi-organ failure. Depending on the global region, 20-50% of patients in the coronavirus disease 2019 (COVID-19) pandemic had diabetes. Given the importance of the link between COVID-19 and diabetes, we have formed an international panel of experts in the field of diabetes and endocrinology to provide some guidance and practical recommendations for the management of diabetes during the pandemic. We aim to briefly provide insight into potential mechanistic links between the novel coronavirus infection and diabetes, present practical management recommendations, and elaborate on the differential needs of several patient groups.