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Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)

28 de março de 2022 atualizado por: Universitätsklinikum Hamburg-Eppendorf

International, Prospective Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic on Two Obese Patient Cohorts Pre- and Post-bariatric Surgery (COBESITY-Study)

Prospective, international multicenter study to investigate the physical and psychological effects of the COVID-19 pandemic in two obese patient cohorts (BMI ≥ 25 kg/m²) pre- and post-bariatric surgery. In addition, the investigation of country-specific differences will be performed.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

The COVID-19 pandemic, first reported in November 2019, has led to a global health systems emergency. The number of confirmed COVID-19-associated deaths, according to WHO, is higher in countries with high obesity prevalence. However, whether obesity is an independent risk factor of the severity of COVID-19 remains unclear.

Obesity represents one of the major health problems worldwide and the COVID-19 pandemic is expected to further increase obesity prevalence rates. Initial research indicates that the pandemic has also led to an increased incidence and/or worsening of depression and eating disorders. Additional weight gain due to the COVID-19 pandemic may be suspected to increase the prevalence of psychological comorbidities in patients before weight-reducing surgery compared to patients who have already undergone weight-reducing surgery.

Therefore, the main aim of this international study is to gain a better understanding of the mental and physical effects of the coronavirus pandemic on obese patients before and after a weight-reducing surgery and use this to develop approaches for solutions. This study also aims to investigate the country-specific differences (Germany vs England) as well as the differences in the mental effects experienced by overweight patients who have or have not been infected with COVID-19.

To achieve these aims, obese patients aged 18 years and older, before and after weight-reducing surgery, will be recruited from the bariatric surgery clinic at King's College Hospital, NHS Trust Foundation as well as from the Medical University Hospital Hamburg-Eppendorf, Germany. Participants will be asked to complete a questionnaire about their health, socio-economic status, and the effects of the COVID-19 pandemic on their physical and mental health. The questionnaire will take 15 minutes to complete and can be done at home or during the patient's appointment at the bariatric surgery clinic to minimise unnecessary travel.

Tipo de estudo

Observacional

Inscrição (Antecipado)

500

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Pia Roser, MD
Número de telefone: +494074100
E-mail: p.roser@uke.de

Locais de estudo

Alemanha
- - Hamburg, Alemanha
    - Recrutamento
    - Universitätsklinikum Hamburg-Eppendorf
    - Contato:
      
      Pia Roser, MD
      
      Número de telefone: 00494074100
      
      E-mail: p.roser@uke.de

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Overweight and obese patients with or without bariatric surgery

Descrição

Inclusion Criteria:

Overweight and obese patient cohort

Age: 18 years and older
BMI ≥ 25kg/m²

Overweight and obese patient cohort with bariatric surgery

Age: 18 years and older
BMI ≥ 25kg/m²
Status post sleeve or gastric bypass surgery

Exclusion Criteria:

Age under 18 years
Cognitive, mental and/or linguistic limitations to complete the questionnaire independently
Severe somatic illnesses, such as tumour diseases
Pregnancy or breastfeeding
Acute need for treatment due to comorbid mental disorders

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
Overweight and obese patient cohort Age: 18 years and older BMI ≥ 25kg/m²
Overweight and obese patient cohort with bariatric surgery Age: 18 years and older BMI ≥ 25kg/m² Status post sleeve or gastric bypass surgery

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
PHQ-4 Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
PSS-10 Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
EDEQ-score Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
BMI Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Impact of the COVID-19 pandemic on mental health (measured by PHQ-4, PSS-10, and EDEQ scores) as well as on physical health (measured by Δ BMI (kg/m^2) before and after the onset of the pandemic) in two obese patient cohorts pre- and post- bariatric surgery.	Before the COVID-19 pandemic vs. since the COVID-19 pandemic

Medidas de resultados secundários

Medida de resultado	Prazo
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Differences in psychological impact in obese patients pre- and post-bariatric surgery Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Differences in psychological impact between obese patients with and without COVID-19 infection Prazo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Before the COVID-19 pandemic vs. since the COVID-19 pandemic

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universitätsklinikum Hamburg-Eppendorf

Colaboradores

King's College Hospital NHS Trust

Investigadores

Investigador principal: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de dezembro de 2021

Conclusão Primária (Antecipado)

1 de dezembro de 2022

Conclusão do estudo (Antecipado)

1 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

19 de março de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de março de 2022

Primeira postagem (Real)

31 de março de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)