Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)
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)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pia Roser, MD
- Número de teléfono: +494074100
- Correo electrónico: p.roser@uke.de
Ubicaciones de estudio
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Hamburg, Alemania
- Reclutamiento
- Universitätsklinikum Hamburg-Eppendorf
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Contacto:
- Pia Roser, MD
- Número de teléfono: 00494074100
- Correo electrónico: p.roser@uke.de
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Overweight and obese patient cohort
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Overweight and obese patient cohort with bariatric surgery
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PHQ-4
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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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.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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PSS-10
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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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.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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EDEQ-score
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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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.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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BMI
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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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.
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Differences in psychological impact in obese patients pre- and post-bariatric surgery
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Differences in psychological impact between obese patients with and without COVID-19 infection
Periodo de tiempo: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Before the COVID-19 pandemic vs. since the COVID-19 pandemic
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- Peso corporal
- COVID-19
- Exceso de peso
Otros números de identificación del estudio
- 2021-100673
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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