- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04600635
Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery (CHRONO-CONF)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in sleep and meal schedules
기간: 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)
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Change in self-reported body weight
기간: 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
기간: 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)
기간: 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)
기간: before (mid-March 2020) at the end (May 11, 2020)
|
before (mid-March 2020) at the end (May 11, 2020)
|
Change in working status
기간: 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)
기간: 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.
기간: 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).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anne-Laure Borel, MD, PhD, University Hospital, Grenoble
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 38RC20.281
- 2020-A02212-37 (기타 식별자: ID RCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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