CClinicalTrials.gg
Status unknownNCT04600635CHRONO-CONFUpdated Oct 23, 2020

Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery

An observational study in Obesity, sponsored by University Hospital, Grenoble. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-23.

Sponsored by University Hospital, Grenoble · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Obesity
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In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients presenting with a medical history of obesity

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureBariatric 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.

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What researchers measure

Primary outcomes

  1. Change in sleep and meal schedules

    Time frame: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)

Secondary outcomes

  1. Change in self-reported body weight

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: before (mid-March 2020) at the end (May 11, 2020)

  5. Change in working status

    Time frame: 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)

    Time frame: 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.

    Time frame: before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Borel AL. Sleep Apnea and Sleep Habits: Relationships with Metabolic Syndrome. Nutrients. 2019 Nov 2;11(11):2628. doi: 10.3390/nu11112628. PubMed 31684029 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04600635
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Oct 23, 2020
Start date
Nov 2, 2020 (estimated)
Primary completion
Jan 31, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Oct 23, 2020

Study contacts

Anne-Laure Borel, MD, PhD
Contact
alborel@chu-grenoble.fr
+33476765509
M'Barka Daoukhi
Contact
mdaoukhi1@chu-grenoble.fr
+33476765509
Anne-Laure Borel, MD, PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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