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Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)

2022年3月28日 更新者：Universitätsklinikum Hamburg-Eppendorf

International, Prospective Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic on Two Obese Patient Cohorts Pre- and Post-bariatric Surgery (COBESITY-Study)

Prospective, international multicenter study to investigate the physical and psychological effects of the COVID-19 pandemic in two obese patient cohorts (BMI ≥ 25 kg/m²) pre- and post-bariatric surgery. In addition, the investigation of country-specific differences will be performed.

研究概览

地位

招聘中

条件

详细说明

The COVID-19 pandemic, first reported in November 2019, has led to a global health systems emergency. The number of confirmed COVID-19-associated deaths, according to WHO, is higher in countries with high obesity prevalence. However, whether obesity is an independent risk factor of the severity of COVID-19 remains unclear.

Obesity represents one of the major health problems worldwide and the COVID-19 pandemic is expected to further increase obesity prevalence rates. Initial research indicates that the pandemic has also led to an increased incidence and/or worsening of depression and eating disorders. Additional weight gain due to the COVID-19 pandemic may be suspected to increase the prevalence of psychological comorbidities in patients before weight-reducing surgery compared to patients who have already undergone weight-reducing surgery.

Therefore, the main aim of this international study is to gain a better understanding of the mental and physical effects of the coronavirus pandemic on obese patients before and after a weight-reducing surgery and use this to develop approaches for solutions. This study also aims to investigate the country-specific differences (Germany vs England) as well as the differences in the mental effects experienced by overweight patients who have or have not been infected with COVID-19.

To achieve these aims, obese patients aged 18 years and older, before and after weight-reducing surgery, will be recruited from the bariatric surgery clinic at King's College Hospital, NHS Trust Foundation as well as from the Medical University Hospital Hamburg-Eppendorf, Germany. Participants will be asked to complete a questionnaire about their health, socio-economic status, and the effects of the COVID-19 pandemic on their physical and mental health. The questionnaire will take 15 minutes to complete and can be done at home or during the patient's appointment at the bariatric surgery clinic to minimise unnecessary travel.

研究类型

观察性的

注册 (预期的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Pia Roser, MD
  • 电话号码：+494074100
  • 邮箱：p.roser@uke.de

学习地点

  • 德国
      • Hamburg、德国
        • 招聘中
        • Universitätsklinikum Hamburg-Eppendorf
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Overweight and obese patients with or without bariatric surgery

描述

Inclusion Criteria:

Overweight and obese patient cohort

  • Age: 18 years and older
  • BMI ≥ 25kg/m²

Overweight and obese patient cohort with bariatric surgery

  • Age: 18 years and older
  • BMI ≥ 25kg/m²
  • Status post sleeve or gastric bypass surgery

Exclusion Criteria:

  • Age under 18 years
  • Cognitive, mental and/or linguistic limitations to complete the questionnaire independently
  • Severe somatic illnesses, such as tumour diseases
  • Pregnancy or breastfeeding
  • Acute need for treatment due to comorbid mental disorders

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Overweight and obese patient cohort
  • Age: 18 years and older
  • BMI ≥ 25kg/m²
Overweight and obese patient cohort with bariatric surgery
  • Age: 18 years and older
  • BMI ≥ 25kg/m²
  • Status post sleeve or gastric bypass surgery

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
PHQ-4
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
PSS-10
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
EDEQ-score
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
BMI
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.
Before the COVID-19 pandemic vs. since the COVID-19 pandemic

次要结果测量

结果测量
大体时间
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Differences in psychological impact in obese patients pre- and post-bariatric surgery
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Differences in psychological impact between obese patients with and without COVID-19 infection
大体时间：Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Before the COVID-19 pandemic vs. since the COVID-19 pandemic

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universitätsklinikum Hamburg-Eppendorf

合作者

King's College Hospital NHS Trust

调查人员

  • 首席研究员：Pia Roser, MD、Medical University Hospital Hamburg-Eppendorf

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年12月1日

初级完成 (预期的)

2022年12月1日

研究完成 (预期的)

2022年12月1日

研究注册日期

首次提交

2022年3月19日

首先提交符合 QC 标准的

2022年3月28日

首次发布 (实际的)

2022年3月31日

研究记录更新

最后更新发布 (实际的)

2022年3月31日

上次提交的符合 QC 标准的更新

2022年3月28日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2021-100673

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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