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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04600635
Collaborator
(none)
500
7.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery
Anticipated Study Start Date :
Nov 2, 2020
Anticipated Primary Completion Date :
Jan 31, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in sleep and meal schedules [before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)]

Secondary Outcome Measures

  1. Change in self-reported body weight [before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)]

  2. Change in obesity-related quality of life evaluated by EQVOD questionnaire [before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).]

  3. Change in physical activity assessed by the short form of International Physical Activity Questionnaire (sf-IPAQ) [before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).]

  4. Change in mood and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS) [before (mid-March 2020) at the end (May 11, 2020)]

  5. Change in working status [before (mid-March 2020) at the end (May 11, 2020)]

  6. Change in food security status assessed by the Household Food Security Scale Measure (HFSSM) [before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).]

  7. Search for a correlation between evolution of the chronotype and evolution of the weight, IPAQS score, HADS score, etc. [before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Anne-Laure Borel, MD, PhD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04600635
Other Study ID Numbers:
  • 38RC20.281
  • 2020-A02212-37
First Posted:
Oct 23, 2020
Last Update Posted:
Oct 23, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 23, 2020