ComorbiditiesCO-RNPCNCT04409197
Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network
An observational study of Comorbidities and Confinement, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comorbidities, Confinement, Obesity
- How many people
- 4,789 participants
- Where
- 1 siteFrance
- Study dates
- 8 May 2020to 11 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from patients enrolled in a Nutritional Psycho-Behavioural Re-education (RNPC) programme in one of the RNPC centres in France.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Comorbidities, Confinement, Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months
Evolution of blood pressure before versus after confinement
Measured: 3 months
Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement
Measured: 3 months
Evaluate the impact of teleconsultation monitoring during containment on weight loss
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start8 May 2020
- Primary completion8 Jun 2020
- Study completion11 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComorbiditiesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,789 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409197
- Sponsor's protocol ID
- 38RC20.150
- Acronym
- CO-RNPC
- Status last verified
- Dec 2025
- First submitted
- 18 May 2020
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bailly S, Fabre O, Legrand R, Pantagis L, Mendelson M, Terrail R, Tamisier R, Astrup A, Clement K, Pepin JL. The Impact of the COVID-19 Lockdown on Weight Loss and Body Composition in Subjects with Overweight and Obesity Participating in a Nationwide Weight-Loss Program: Impact of a Remote Consultation Follow-Up-The CO-RNPC Study. Nutrients. 2021 Jun 23;13(7):2152. doi: 10.3390/nu13072152.
PubMed 34201490
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network
- ClinicalTrials.gov ID
- NCT04409197
- Acronym / sponsor ID
- CO-RNPC / 38RC20.150
- Conditions
- Comorbidities, Confinement, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,789 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 11 Jul 2020 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from patients enrolled in a Nutritional Psycho-Behavioural Re-education (RNPC) programme in one of the RNPC centres in France.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France
Time frame: 3 months
4 secondary outcomes
Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight
Time frame: 3 months
Evolution of blood pressure before versus after confinement
Time frame: 3 months
Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement
Time frame: 3 months
Evaluate the impact of teleconsultation monitoring during containment on weight loss
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 34201490Bailly S, Fabre O, Legrand R, Pantagis L, Mendelson M, Terrail R, Tamisier R, Astrup A, Clement K, Pepin JL. The Impact of the COVID-19 Lockdown on Weight Loss and Body Composition in Subjects with Overweight and Obesity Participating in a Nationwide Weight-Loss Program: Impact of a Remote Consultation Follow-Up-The CO-RNPC Study. Nutrients. 2021 Jun 23;13(7):2152. doi: 10.3390/nu13072152.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comorbidities and Confinement, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.