ObesityCHRONO-CONFNCT04600635
Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery
An observational study of Obesity, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting with a medical history of obesity
Who may be able to join
- 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
Who cannot join
- Subjects refusing to participate
- Subjects who stayed in a country that did not organize containment during the COVID-19 pandemic.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Obesity
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep and meal schedules
Measured: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
Secondary outcomes (7)
Change in self-reported body weight
Measured: 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
Measured: 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)
Measured: 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)
Measured: before (mid-March 2020) at the end (May 11, 2020)
Change in working status
Measured: before (mid-March 2020) at the end (May 11, 2020)
Change in food security status assessed by the Household Food Security Scale Measure (HFSSM)
Measured: 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.
Measured: before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start2 Nov 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Borel, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600635
- Sponsor's protocol ID
- 38RC20.281
- Other IDs
- 2020-A02212-37
- Acronym
- CHRONO-CONF
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04600635
- Acronym / sponsor ID
- CHRONO-CONF / 38RC20.281
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 2 Nov 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a medical history of obesity | – | Procedure: Bariatric surgeryPatients included are subject who entered a structured program of care for their obesity, with or without bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with a medical history of obesity
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects refusing to participate
- Subjects who stayed in a country that did not organize containment during the COVID-19 pandemic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgerySome 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. | Procedure or surgery | patients with a medical history of obesity |
Primary outcome
Change in sleep and meal schedules
Time frame: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
7 secondary outcomes
Change in self-reported body weight
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: before (mid-March 2020) at the end (May 11, 2020)
Change in working status
Time frame: before (mid-March 2020) at the end (May 11, 2020)
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 31684029Borel AL. Sleep Apnea and Sleep Habits: Relationships with Metabolic Syndrome. Nutrients. 2019 Nov 2;11(11):2628. doi: 10.3390/nu11112628.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laure Borel, MD, PhD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Laure Borel, MD, PhD (+33476765509, alborel@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep and meal schedules (time frame: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.