Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

Obesity Clinical Trial

— CO-RNPC  

Official title:

Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409197
• Other study ID #: 38RC20.150
• Status: Completed
• Start date: May 8, 2020
• Est. completion date: July 11, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption.

The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4789
• Est. completion date: July 11, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI > 25 kg/m² and/or waist circumference > 80 cm in women and 94 cm in men

• Persons registered in the RNPC program

• Be legally able to give consent after adequate information and submission of the information note

• Person affiliated to social security

Exclusion Criteria:

• Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.

Related Conditions & MeSH terms

• Comorbidities
• Confinement
• Obesity

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France		3 months
Secondary	Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight	Change in waist circumference, blood pressure, percentage of lean, fluid and muscle mass before and after the confinement period	3 months
Secondary	Evolution of blood pressure before versus after confinement		3 months
Secondary	Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement		3 months
Secondary	Evaluate the impact of teleconsultation monitoring during containment on weight loss		3 months