<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04409197</url>
  </required_header>
  <id_info>
    <org_study_id>38RC20.150</org_study_id>
    <nct_id>NCT04409197</nct_id>
  </id_info>
  <brief_title>Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network</brief_title>
  <acronym>CO-RNPC</acronym>
  <official_title>Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During confinement, food intake can become compulsive, physical activity is significantly&#xD;
      reduced, sleep is altered with exacerbated anxiety and stress levels and increased family&#xD;
      violence. In some at-risk patients, mental health may even deteriorate. The temptation is&#xD;
      great for all to take refuge in food or in front of screens. The main elements that can&#xD;
      impact weight changes during this period of confinement are stress and anxiety, lack of&#xD;
      physical activity, changes in eating habits, sleep disturbance and alcohol consumption.&#xD;
&#xD;
      The investigators wish to study the impact of confinement on pre-post confinement weight loss&#xD;
      kinetics in adults included in weight reduction programs (RNPC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2020</start_date>
  <completion_date type="Actual">July 11, 2020</completion_date>
  <primary_completion_date type="Actual">June 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight</measure>
    <time_frame>3 months</time_frame>
    <description>Change in waist circumference, blood pressure, percentage of lean, fluid and muscle mass before and after the confinement period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of blood pressure before versus after confinement</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the impact of teleconsultation monitoring during containment on weight loss</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">4789</enrollment>
  <condition>Comorbidities</condition>
  <condition>Confinement</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from patients enrolled in a Nutritional Psycho-Behavioural&#xD;
        Re-education (RNPC) programme in one of the RNPC centres in France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 25 kg/m² and/or waist circumference &gt; 80 cm in women and 94 cm in men&#xD;
&#xD;
          -  Persons registered in the RNPC program&#xD;
&#xD;
          -  Be legally able to give consent after adequate information and submission of the&#xD;
             information note&#xD;
&#xD;
          -  Person affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being unable to understand, follow objectives and methods due to cognition or language&#xD;
             problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and&#xD;
             parturient; subject under administrative or judicial control, persons who are&#xD;
             protected under the act.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Louis PEPIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04409197
org study id: 38RC20.150
nct id: NCT04409197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
observational model: Cohort
time perspective: Prospective
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
measure: Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight
time frame: 3 months
description: Change in waist circumference, blood pressure, percentage of lean, fluid and muscle mass before and after the confinement period
measure: Evolution of blood pressure before versus after confinement
time frame: 3 months
measure: Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement
time frame: 3 months
measure: Evaluate the impact of teleconsultation monitoring during containment on weight loss
time frame: 3 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Louis PEPIN
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor