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

28 mars 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Pia Roser, MD
Numéro de téléphone: +494074100
E-mail: p.roser@uke.de

Lieux d'étude

Allemagne
- - Hamburg, Allemagne
    - Recrutement
    - Universitätsklinikum Hamburg-Eppendorf
    - Contact:
      
      Pia Roser, MD
      
      Numéro de téléphone: 00494074100
      
      E-mail: p.roser@uke.de

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Overweight and obese patients with or without bariatric surgery

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
PHQ-4 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Délai
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic Délai: 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 Délai: 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 Délai: Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Before the COVID-19 pandemic vs. since the COVID-19 pandemic

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universitätsklinikum Hamburg-Eppendorf

Collaborateurs

King's College Hospital NHS Trust

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 décembre 2021

Achèvement primaire (Anticipé)

1 décembre 2022

Achèvement de l'étude (Anticipé)

1 décembre 2022

Dates d'inscription aux études

Première soumission

19 mars 2022

Première soumission répondant aux critères de contrôle qualité

28 mars 2022

Première publication (Réel)

31 mars 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)