OBIMPACOV: Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.

• Sponsor: University Hospital, Bordeaux (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04910607
• Collaborator: Région Nouvelle Aquitaine (Other)
• Enrollment: 310
• Locations: 3
• Anticipated Duration (Months): 8.3
• Patients Per Site: 103.3
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief Summary

The population suffering from obesity is particularly at risk during this pandemic period. The Nouvelle Aquitaine region is not spared, since according to the regional epidemiological report of 7 May 2020, carried out by Santé Publique France, 39.2% of cases admitted to the intensive care unit in Nouvelle Aquitaine and presenting risk factors are overweight or obese.

Other risk factors, such as social-environmental factors, must be taken into consideration. Socio-demographic surveys in this area highlight the socio-economic and territorial inequalities that interfere with obesity issues. Similarly, the issues of stigmatisation and isolation seem to be at the heart of the question of how to deal with these people.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Covid19	Other: Questionnaire; Other: Interview

Detailed Description

This is a prospective multicentre study. Participating patients will be recruited from the Specialised Obesity Centres (CHU and SSR, as well as patient associations) to fill in a questionnaire and take part in an interview (a varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age).

The medical and paramedical staff involved in the partner CSOs and the patients' resources (identified by the patients' associations) will also be asked to participate in a semi-directive interview.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 310 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Social and Psychological Impacts of SARS-Cov-2 Pandemic Period in the Obese Population.
• Actual Study Start Date: Jan 21, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patient Participating patients will be recruited from the Specialised Obesity Centres =CSO (CHU and Follow-up and rehabilitation care (SSR), as well as patient associations) to fill in a questionnaire and take part in an interview (varied panel representative of the target population in terms of place of residence, socio-professional category, sex and age).	Other: Questionnaire; Questionnaire with 4 axes: sociological, reflexive medical, prospective medical, transversal; Other: Interview; Interview concerning health pathways, experience of confinement, consequences of confinement on health, representations of obesity.
Professional Medical and paramedical staff involved in the partner CSOs will also be asked to participate in a semi-structured interview.	Other: Interview; Interview concerning health pathways, experience of confinement, consequences of confinement on health, representations of obesity.

Outcome Measures

Primary Outcome Measures

1. Analysed social and psychological impacts of containment [9 months after inclusion day]

   Thanks to sociology questionnaire based on the experience and paths of individuals (not a score). The treatments carried out will be limited to cross sorting and flat sorting, factorial analyzes and -previously- the chi-square analysis.

2. Consequences of social distancing during the containment [9 months after inclusion day]

   Thanks to sociology questionnaire based on the experience and paths of individuals(not a score). The treatments carried out will be limited to cross sorting and flat sorting, factorial analyzes and -previously- the chi-square analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients 18 years of age.

• Be registered in an active file of the 3 partner CSOs.

Exclusion Criteria:

• Patients under 18 years of age.

• Patients under protective measures or deprived of liberty:

• pregnant or breastfeeding woman,

• under guardianship,

• under guardianship,

• safeguard of justice,

• incarcerated.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Limoges	Limoges		France	87042
2	Hôpital Haut-Lévêque	Pessac		France	33604
3	CHU de Poitiers	Poitiers		France	86000

Sponsors and Collaborators

• University Hospital, Bordeaux
• Région Nouvelle Aquitaine

Investigators

• Study Chair: Arnaud ALESSANDRIN, Dr, Universite de Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT04910607
• Other Study ID Numbers: CHUBX 2020/38
• First Posted: Jun 2, 2021
• Last Update Posted: Mar 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Bordeaux: Obesity; COVID19; semi-directive interview
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Mar 10, 2022