NCT05303012

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 19, 2022

Last Update Submit

March 28, 2022

Conditions

COVID-19 PandemicOverweight and Obesity

Outcome Measures

Primary Outcomes (4)

  • 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 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

    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

    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

    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

Secondary Outcomes (3)

  • 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

  • Differences in psychological impact in obese patients pre- and post-bariatric surgery

    Before the COVID-19 pandemic vs. since the COVID-19 pandemic

  • Differences in psychological impact between obese patients with and without COVID-19 infection

    Before the COVID-19 pandemic vs. since the COVID-19 pandemic

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Overweight and obese patients with or without bariatric surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19OverweightObesity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pia Roser, MD

    Medical University Hospital Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia Roser, MD

CONTACT

+494074100p.roser@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 31, 2022

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)