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

Overweight and Obesity Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303012
• Other study ID #: 2021-100673
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Pia Roser, MD
• Phone: +494074100
• Email: p.roser[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	King's College Hospital NHS Trust

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ-4	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 ? 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
Primary	PSS-10	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 ? 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
Primary	EDEQ-score	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 ? 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
Primary	BMI	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 ? 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
Secondary	Country-specific differences of the physical and psychological impact of the COVID-19 pandemic		Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Secondary	Differences in psychological impact in obese patients pre- and post-bariatric surgery		Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Secondary	Differences in psychological impact between obese patients with and without COVID-19 infection		Before the COVID-19 pandemic vs. since the COVID-19 pandemic