NCT04600635

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 2, 2020

Last Update Submit

October 19, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in sleep and meal schedules

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

Secondary Outcomes (7)

  • Change in self-reported body weight

    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

    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)

    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)

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

  • Change in working status

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

  • +2 more secondary outcomes

Study Arms (1)

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

Bariatric surgeryPROCEDURE

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.

patients with a medical history of obesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting with a medical history of obesity

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

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

    PMID: 31684029BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Anne-Laure Borel, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure Borel, MD, PhD

CONTACT

+33476765509alborel@chu-grenoble.fr

M'Barka Daoukhi

CONTACT

+33476765509mdaoukhi1@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 23, 2020

Study Start

November 2, 2020

Primary Completion

January 31, 2021

Study Completion

June 30, 2021

Last Updated

October 23, 2020

Record last verified: 2020-10