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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04409197
Other study ID # 38RC20.150
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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