NCT04910607

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

April 16, 2021

Last Update Submit

December 29, 2023

Conditions

Keywords

ObesityCOVID19semi-directive interview

Outcome Measures

Primary Outcomes (2)

  • Analysed social and psychological impacts of containment

    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.

    9 months after inclusion day

  • Consequences of social distancing during the containment

    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.

    9 months after inclusion day

Study Arms (2)

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: QuestionnaireOther: Interview

Professional

Medical and paramedical staff involved in the partner CSOs will also be asked to participate in a semi-structured interview.

Other: Interview

Interventions

Questionnaire with 4 axes: sociological, reflexive medical, prospective medical, transversal

Patient

Interview concerning health pathways, experience of confinement, consequences of confinement on health, representations of obesity.

PatientProfessional

Eligibility Criteria

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

The obese population is the target population of the study.

You may qualify if:

  • Patients 18 years of age.
  • Be registered in an active file of the 3 partner CSOs.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU de Limoges

Limoges, 87042, France

Location

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

ObesityCOVID-19

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Arnaud ALESSANDRIN, Dr

    Universite de Bordeaux

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 16, 2021

First Posted

June 2, 2021

Study Start

January 21, 2022

Primary Completion

July 28, 2023

Study Completion

July 28, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations