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Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery (CHRONO-CONF)

2020年10月19日 更新者:University Hospital, Grenoble
Confinement disrupts social habits, the absence of professional activity or teleworking creates the possibility for individuals to work and/or sleep at times that are most convenient for them. Investigators hypothesize that subjects with a history of obesity will tend, during confinement, to return to their spontaneous chronotype. The evolution of chronotypes between the pre-confinement period and during confinement will allow to measure the percentage of subjects who are not usually living according to their spontaneous chronotype, due to social constraints. Finally, we wish to retrospectively question the subjects on the impact of confinement on their eating habits, physical activity, mood, employment, and so on.

研究概览

地位

未知

条件

详细说明

Sleep patterns, evaluated in hunter-gatherer populations, show that without artificial interference, sleep is of course concomitant with the decrease in luminosity, but is also regulated by the outside temperature. Light pollution from night lighting and artificially regulated temperature contribute to distancing us from these physiological signals. In addition, the leisure activities linked to the screens encourage a voluntary restriction of sleep manifested by a later bedtime, whereas social constraints always impose the time of getting up. Sleep debt accumulates during the week and compensates for non-working days inducing a social jet lag of small amplitude, but repeated each week. Subjects who spontaneously or habitually develop a late chronotype (i.e. a propensity to be a "late sleeper, late riser") are the most exposed to this social jetlag between days worked when the sleep debt accumulates and days off when the sleep debt compensates.

It has been widely demonstrated that a short sleep duration promotes weight gain. Subjects with a late chronotype associate a short sleep duration on days when they work and a significant social jetlag on days when they do not work. This late chronotype is associated with unfavourable eating behaviour and more emotional eating and constitutes a risk of developing metabolic diseases.

Confinement disrupts social habits: lack of work activity or teleworking creates the possibility for individuals to work and/or sleep at times that are most convenient for them. Investigators hypothesize that subjects with a history of obesity will have tended, during confinement, to return to their spontaneous chronotype. The evolution of chronotypes between the pre-confinement period and during confinement will allow to measure the percentage of subjects who are not usually living according to their spontaneous chronotype, due to social constraints. Finally, we wish to retrospectively question the subjects on the impact of confinement on their eating habits, physical activity, mood and employment.

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。

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

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients presenting with a medical history of obesity

描述

Inclusion Criteria:

  • Adult (>18 years-old, no upper limit)
  • Included in the care pathways that prepare and then follow bariatric surgery
  • Who have an e-mail address and internet access

Exclusion Criteria:

  • Subjects refusing to participate
  • Subjects who stayed in a country that did not organize containment during the COVID-19 pandemic.

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
干预/治疗
patients with a medical history of obesity
Patients included are subject who entered a structured program of care for their obesity, with or without bariatric surgery.
Some patients in the cohort are followed by a multidisciplinary team in preparation for bariatric surgery. Others have already undergone bariatric surgery and are being followed up postoperatively.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in sleep and meal schedules
大体时间:before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)

次要结果测量

结果测量
大体时间
Change in self-reported body weight
大体时间:before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
Change in obesity-related quality of life evaluated by EQVOD questionnaire
大体时间:before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).
before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).
Change in physical activity assessed by the short form of International Physical Activity Questionnaire (sf-IPAQ)
大体时间:before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).
before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).
Change in mood and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS)
大体时间:before (mid-March 2020) at the end (May 11, 2020)
before (mid-March 2020) at the end (May 11, 2020)
Change in working status
大体时间:before (mid-March 2020) at the end (May 11, 2020)
before (mid-March 2020) at the end (May 11, 2020)
Change in food security status assessed by the Household Food Security Scale Measure (HFSSM)
大体时间:before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
Search for a correlation between evolution of the chronotype and evolution of the weight, IPAQS score, HADS score, etc.
大体时间:before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).

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。

调查人员

  • 首席研究员:Anne-Laure Borel, MD, PhD、University Hospital, Grenoble

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (预期的)

2020年11月2日

初级完成 (预期的)

2021年1月31日

研究完成 (预期的)

2021年6月30日

研究注册日期

首次提交

2020年10月2日

首先提交符合 QC 标准的

2020年10月19日

首次发布 (实际的)

2020年10月23日

研究记录更新

最后更新发布 (实际的)

2020年10月23日

上次提交的符合 QC 标准的更新

2020年10月19日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 38RC20.281
  • 2020-A02212-37 (其他标识符:ID RCB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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