Clinical trial NCT05303012: Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pandemic
Overweight and Obesity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2022-03-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese patients with or without bariatric surgery

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PHQ-4
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
measure: PSS-10
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
measure: EDEQ-score
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
measure: BMI
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Secondary outcomes:
measure: Country-specific differences of the physical and psychological impact of the COVID-19 pandemic
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
measure: Differences in psychological impact in obese patients pre- and post-bariatric surgery
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
measure: Differences in psychological impact between obese patients with and without COVID-19 infection
timeFrame: Before the COVID-19 pandemic vs. since the COVID-19 pandemic
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Medical University Hospital Hamburg-Eppendorf
name: Pia Roser, MD
role: PRINCIPAL_INVESTIGATOR
References: