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临床试验/NCT05430542
NCT05430542已完成不适用

Different Variations of Intra-familial Body Mass Index Subjected to COVID-19 Lockdown

University of Bari1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
298
试验地点
1
主要终点
Effects of COVID-19 lockdown on changes of anthropometric indices

研究概览

简要总结

The COVID-19 lockdown has represented an unedited model of increased metabolic risk in all age groups, due to negative changes in dietary habits, physical activity, lifestyle. These effects have been generally explored at a population level in distinct age groups. Potential intra-familial, specific effects in adults and children sharing the same socio-economic, cultural level and living habits have been scarcely explored. The investigators aimed to extend the previous observations concerning anthropometric data at the intra-familial level. In particular, The investigators prospectively characterized the variations in lifestyle habits and related outcomes over a 2 two months COVID-19 lockdown period, exploring both parents and their children. A cohort of 149 couple parent/children were prospectively enrolled. By a validated questionnaire The investigators explored changes of Body Mass Index (BMI) and individual lifestyle during a 2-month lockdown.

详细描述

The COVID-19 lockdown has represented an unedited model of increased metabolic risk in all age groups, due to negative changes in dietary habits, physical activity, lifestyle. These effects have been generally explored at a population level in distinct age groups. Potential intra-familial, specific effects in adults and children sharing the same socio-economic, cultural level and living habits have been scarcely explored. The investigators aimed to extend the previous observations concerning anthropometric data at the intra-familial level. In particular, The investigators prospectively characterized the variations in lifestyle habits and related outcomes over a 2 two months COVID-19 lockdown period, exploring both parents and their children. A cohort of 149 couple parent/children were prospectively enrolled. By a validated questionnaire The investigators explored changes of Body Mass Index (BMI) and individual lifestyle during a 2-month lockdown.

The pandemic diffusion of the new severe acute respiratory syndrome coronavirus SARS-CoV-2 caused major impacts on health, economy, and social dynamics. During the first wave of the pandemic, besides the direct effect of the COVID-19 disease, staying at home has promoted, in non-infected subjects, sedentary lifestyle, negative psychological consequences, restriction in spending, and accumulation of long-life food with limited use of fresh foods, such as seasonal fruit and vegetables. As a consequence, the lockdown has represented a population-based, inedited model of increased metabolic risk in all age groups, able to affect the health status in a relatively short period.

Previous studies reported negative metabolic outcomes of the lockdown both adults and in children. These effects have been linked with altered eating behavior and lifestyle, with a significant reduction in physical activity, and with an impairment of psychological health. However, these studies were based on self-reported questionnaires, which may lead to misreporting of data. Furthermore, the reported effects on body size variations have been generally explored, at a population level, in separate age groups, and the existence of possible intra-familial, distinct outcomes in adults and children sharing the same critical event and living environment have been scarcely explored.

Although several studies have shown the impact of Lockdown on metabolic status, potential intra-familial, specific effects in adults and children sharing the same socio-economic, cultural level and living habits have been scarcely explored. In the present study The investigators had the chance to dissect the intra-familial impact of two month of lockdown due to COVID-19 pandemic on BMI in a large cohort of non-infected parents and in their children/adolescents.

Primary objective: to characterize changes of dietary habits, lifestyle and anthropometric indices in parents and in their children during lockdown.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects able to sign the Informed Consent
  • Subjects who were in Lockdown
  • For children, the inclusion criteria were: (i) age between 5 and 18 years; (ii) absence of ongoing therapies.

排除标准

  • Subjects not able to provide informed consent
  • SARS-CoV-2 infection
  • Diagnosis of organic diseases including neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders.

结局指标

主要结局

Effects of COVID-19 lockdown on changes of anthropometric indices

时间窗: 2 months

To characterize changes of dietary habits, lifestyle and anthropometric indices in parents and in their children during lockdown.

次要结局

未报告次要终点

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

piero portincasa

Professor, MD

University of Bari

研究点 (1)

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