- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04600635
Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery (CHRONO-CONF)
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in sleep and meal schedules
Lasso di tempo: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
|
before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in self-reported body weight
Lasso di tempo: before (mid-March 2020) at the end (May 11, 2020) and after containment (September 2020)
|
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
Lasso di tempo: before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).
|
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)
Lasso di tempo: before (mid-March 2020), at the end (May 11, 2020) and after confinement (September 2020).
|
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)
Lasso di tempo: before (mid-March 2020) at the end (May 11, 2020)
|
before (mid-March 2020) at the end (May 11, 2020)
|
Change in working status
Lasso di tempo: before (mid-March 2020) at the end (May 11, 2020)
|
before (mid-March 2020) at the end (May 11, 2020)
|
Change in food security status assessed by the Household Food Security Scale Measure (HFSSM)
Lasso di tempo: before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
|
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.
Lasso di tempo: before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
|
before (mid-March 2020), at the end (May 11, 2020) and after containment (September 2020).
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Anne-Laure Borel, MD, PhD, University Hospital, Grenoble
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 38RC20.281
- 2020-A02212-37 (Altro identificatore: ID RCB)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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