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

Obesity Clinical Trial

— CHRONO-CONF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04600635
• Other study ID #: 38RC20.281
• Secondary ID: 2020-A02212-37
• Status: Not yet recruiting
• Start date: November 2, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: University Hospital, Grenoble
• Contact: Anne-Laure Borel, MD, PhD
• Phone: +33476765509
• Email: alborel[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

References & Publications (1)

Borel AL. Sleep Apnea and Sleep Habits: Relationships with Metabolic Syndrome. Nutrients. 2019 Nov 2;11(11). pii: E2628. doi: 10.3390/nu11112628. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep and meal schedules		before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
Secondary	Change in self-reported body weight		before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
Secondary	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).
Secondary	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).
Secondary	Change in mood and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS)		before (mid-March 2020) at the end (May 11, 2020)
Secondary	Change in working status		before (mid-March 2020) at the end (May 11, 2020)
Secondary	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).
Secondary	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).