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

2022年3月28日更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Pia Roser, MD
電話番号：+494074100
メール：p.roser@uke.de

研究場所

ドイツ
- - Hamburg、ドイツ
    - 募集
    - Universitätsklinikum Hamburg-Eppendorf
    - コンタクト：
      
      Pia Roser, MD
      
      電話番号：00494074100
      
      メール：p.roser@uke.de

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Overweight and obese patients with or without bariatric surgery

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
PHQ-4 時間枠：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 時間枠：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 時間枠：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 時間枠：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

二次結果の測定

結果測定	時間枠
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic 時間枠：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 時間枠：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 時間枠：Before the COVID-19 pandemic vs. since the COVID-19 pandemic	Before the COVID-19 pandemic vs. since the COVID-19 pandemic

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Universitätsklinikum Hamburg-Eppendorf

協力者

King's College Hospital NHS Trust

捜査官

主任研究者：Pia Roser, MD、Medical University Hospital Hamburg-Eppendorf

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年12月1日

一次修了 (予想される)

2022年12月1日

研究の完了 (予想される)

2022年12月1日

試験登録日

最初に提出

2022年3月19日

QC基準を満たした最初の提出物

2022年3月28日

最初の投稿 (実際)

2022年3月31日

学習記録の更新

投稿された最後の更新 (実際)