Obesity Clinical Trial
— CO-RNPCOfficial title:
Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network
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 |
Verified date | August 2020 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Grenoble Alpes | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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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