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)
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Контакты исследования
- Имя: Pia Roser, MD
- Номер телефона: +494074100
- Электронная почта: p.roser@uke.de
Места учебы
-
-
-
Hamburg, Германия
- Рекрутинг
- Universitätsklinikum Hamburg-Eppendorf
-
Контакт:
- Pia Roser, MD
- Номер телефона: 00494074100
- Электронная почта: p.roser@uke.de
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
|
Overweight and obese patient cohort
|
|
Overweight and obese patient cohort with bariatric surgery
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
PHQ-4
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Before the COVID-19 pandemic vs. since the COVID-19 pandemic
|
Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Pia Roser, MD, Medical University Hospital Hamburg-Eppendorf
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2021-100673
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .