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

Completed

• Conditions: Confinement; Obesity; Comorbidities

• Registration Number: NCT04409197
• Lead Sponsor: University Hospital, Grenoble

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-08
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Primary Completion: 2020-06-08
• Study Completion: 2020-07-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4789

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evolution of blood pressure before versus after confinement	3 months
Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement	3 months
Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight	3 months	Change in waist circumference, blood pressure, percentage of lean, fluid and muscle mass before and after the confinement period
Evaluate the impact of teleconsultation monitoring during containment on weight loss	3 months

Trial Locations

Locations (1)

CHU Grenoble Alpes; 🇫🇷 Grenoble, France