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- Ensaio Clínico NCT04600635
Effect of Confinement on Circadian Rhythms of Patients Integrated Into a Care Pathway for Bariatric Surgery (CHRONO-CONF)
Visão geral do estudo
Descrição detalhada
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 de estudo
Inscrição (Antecipado)
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Change in sleep and meal schedules
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Change in self-reported body weight
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: before (mid-March 2020) at the end (May 11, 2020)
|
before (mid-March 2020) at the end (May 11, 2020)
|
Change in working status
Prazo: 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)
Prazo: 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.
Prazo: 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).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anne-Laure Borel, MD, PhD, University Hospital, Grenoble
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 38RC20.281
- 2020-A02212-37 (Outro identificador: ID RCB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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