xml: <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/NCT05982132</url>
    </required_header>
    <id_info>
      <org_study_id>19_RIPH3_13</org_study_id>
      <nct_id>NCT05982132</nct_id>
    </id_info>
    <brief_title>Weight Changes Among Martinican Prisoners</brief_title>
    <acronym>NUTRI-LAJÔL</acronym>
    <official_title>Weight Changes Among Martinican Prisoners</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Center of Martinique</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Center of Martinique</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>
        Assessment of body weight change among prisoners in Martinique between admission in jail and&#xD;
        3 months later expressed as a percentage of admission weight. Intensity of physical&#xD;
        activities, nutrition intakes and psychological state are also studied to describe associated&#xD;
        factors to body weight change.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Several studies described how weight of prisoners may vary during incarceration. Taking or&#xD;
        losing weight both have health consequences but are also a warning signal for several&#xD;
        pathologies. Female prisoners are more likely getting fat, data are rare and contradictory&#xD;
        about male prisoners. A single study was conducted in mainland France and including few men.&#xD;
        Furthermore, Martinique is a department where the prevalence of overweight and diabetes in&#xD;
        the general population are higher than the national average. Prisoners most often have&#xD;
        socio-demographic featuring and morbidity different from the general population (more men,&#xD;
        some over-represented age groups, addictive behaviors and more frequent mental health&#xD;
        problems ...). Aspects nutritional information is less often documented. What about the&#xD;
        weight variation of people held in Martinique? Is incarceration always accompanied by weight&#xD;
        gain? What are factors associated with weight variation? This study aims to answer to those&#xD;
        questions by including all men newly admit in the only martinican jail aged from 18 to 44&#xD;
        years and consenting. During admission medical consultation, prisoners will fill guided by&#xD;
        the investigator doctor of self-questionnaires of the evaluation of the level of physical&#xD;
        activity, assessment of nutritional intakes and psychological state before incarceration.&#xD;
        Measurement of weight and other anthropometrics data will be done, investigator doctor will&#xD;
        collect data about socio-economic featuring, medical history and treatment. Three months&#xD;
        later, a research technician will interview included prisoners in their life place and guide&#xD;
        them to fill new self-questionnaires of the evaluation of the level of physical activity,&#xD;
        assessment of nutritional intakes and psychological state during incarceration. Measure&#xD;
        weight and other anthropometrics data and collecting data about new treatment, stopping&#xD;
        tobacco will be done during this interview.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 11, 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Weight change between baseline and Month 3 visit among men aged 18 to 44, newly incarcerated in martinican jail</measure>
      <time_frame>The primary outcome will be collected at baseline (entrance medical examination) and Month 3 visit</time_frame>
      <description>Weight change between baseline and Month 3 visit expressed as a percentage</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Body mass index measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and Month 3 visit</time_frame>
      <description>BMI in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist size measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Waist size in centimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lean mass measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Lean body mass is measured with a body composition scale in kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body fat measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Body fat is measured with a body composition scale in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage body water measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Percentage body water is measured with a body composition scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visceral fat measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Visceral fat is measured with a body composition scale in level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Basal metabolic rate measurement change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Basal metabolic rate is measured with a body composition scale in kCal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sportive activities intensity change can be associated with weight change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Change in intensity of sports activities measured using a self-questionnaire according to RICCI &amp; GAGNON</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The variation of nutrition intakes change can be associated with weight change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>The variation in nutritional intake is assessed by means of a questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological state change can be associated with weight change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Change in psychological state will be assessed by the STAY self-questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New treatment can be associated with weight change between baseline and Month 3 visit</measure>
      <time_frame>This outcome will be collected at baseline (entrance medical examination) and visit at 3 months</time_frame>
      <description>Introduction or not of new treatment that may have an impact on the weight per data collection. Name of new treatment (in case of) will be notifed in order to search if weigth change is one of his sides effect known.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">227</enrollment>
    <condition>Weight Gain</condition>
    <condition>Weight Loss</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>anthropometric measurement</intervention_name>
      <description>Measurement of weight and other anthropometrics data</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          all men aged from 18 to 44 incarcerated in martinican jail during inclusion period and&#xD;
          consenting&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all men newly incarcerated in martinican jail during inclusion period&#xD;
  &#xD;
            -  age between 18 and 44 years old&#xD;
  &#xD;
            -  having given his consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  female&#xD;
  &#xD;
            -  44 years old and up&#xD;
  &#xD;
            -  not understanding or speaking French or English&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Eligibility is based on gender : only men</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>44 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Veronique PELONDE-ERIMEE, RCA</last_name>
      <phone>0596592697</phone>
      <phone_ext>+596</phone_ext>
      <email>veronique.pelonde-erimee@chu-martinique.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Martinique</name>
        <address>
          <city>Ducos</city>
          <zip>97224</zip>
          <country>Martinique</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Véronique Pelonde-Erimée</last_name>
        <email>veronique.pelonde-erimee@chu-martinique.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>Martinique</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 14, 2022</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prisoners</keyword>
    <keyword>Body weight</keyword>
    <keyword>Male</keyword>
    <keyword>French West Indies</keyword>
    <keyword>Epidemiology</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
      <mesh_term>Weight Gain</mesh_term>
      <mesh_term>Body Weight Changes</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982132
  org study id: 19_RIPH3_13
  nct id: NCT05982132
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Assessment of body weight change among prisoners in Martinique between admission in jail and
        3 months later expressed as a percentage of admission weight. Intensity of physical
        activities, nutrition intakes and psychological state are also studied to describe associated
        factors to body weight change.
  Several studies described how weight of prisoners may vary during incarceration. Taking or
        losing weight both have health consequences but are also a warning signal for several
        pathologies. Female prisoners are more likely getting fat, data are rare and contradictory
        about male prisoners. A single study was conducted in mainland France and including few men.
        Furthermore, Martinique is a department where the prevalence of overweight and diabetes in
        the general population are higher than the national average. Prisoners most often have
        socio-demographic featuring and morbidity different from the general population (more men,
        some over-represented age groups, addictive behaviors and more frequent mental health
        problems ...). Aspects nutritional information is less often documented. What about the
        weight variation of people held in Martinique? Is incarceration always accompanied by weight
        gain? What are factors associated with weight variation? This study aims to answer to those
        questions by including all men newly admit in the only martinican jail aged from 18 to 44
        years and consenting. During admission medical consultation, prisoners will fill guided by
        the investigator doctor of self-questionnaires of the evaluation of the level of physical
        activity, assessment of nutritional intakes and psychological state before incarceration.
        Measurement of weight and other anthropometrics data will be done, investigator doctor will
        collect data about socio-economic featuring, medical history and treatment. Three months
        later, a research technician will interview included prisoners in their life place and guide
        them to fill new self-questionnaires of the evaluation of the level of physical activity,
        assessment of nutritional intakes and psychological state during incarceration. Measure
        weight and other anthropometrics data and collecting data about new treatment, stopping
        tobacco will be done during this interview.
  observational model: Case-Only
  time perspective: Prospective
  measure: Weight change between baseline and Month 3 visit among men aged 18 to 44, newly incarcerated in martinican jail
  time frame: The primary outcome will be collected at baseline (entrance medical examination) and Month 3 visit
  description: Weight change between baseline and Month 3 visit expressed as a percentage
  measure: Body mass index measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and Month 3 visit
  description: BMI in kg/m^2
  measure: Waist size measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Waist size in centimeters
  measure: Lean mass measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Lean body mass is measured with a body composition scale in kg
  measure: Body fat measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Body fat is measured with a body composition scale in percentage
  measure: Percentage body water measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Percentage body water is measured with a body composition scale
  measure: Visceral fat measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Visceral fat is measured with a body composition scale in level
  measure: Basal metabolic rate measurement change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Basal metabolic rate is measured with a body composition scale in kCal
  measure: Sportive activities intensity change can be associated with weight change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Change in intensity of sports activities measured using a self-questionnaire according to RICCI & GAGNON
  measure: The variation of nutrition intakes change can be associated with weight change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: The variation in nutritional intake is assessed by means of a questionnaire
  measure: Psychological state change can be associated with weight change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Change in psychological state will be assessed by the STAY self-questionnaire
  measure: New treatment can be associated with weight change between baseline and Month 3 visit
  time frame: This outcome will be collected at baseline (entrance medical examination) and visit at 3 months
  description: Introduction or not of new treatment that may have an impact on the weight per data collection. Name of new treatment (in case of) will be notifed in order to search if weigth change is one of his sides effect known.
  intervention type: Other
  intervention name: anthropometric measurement
  description: Measurement of weight and other anthropometrics data
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Eligibility is based on gender : only men
  minimum age: 18 Years
  maximum age: 44 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Veronique PELONDE-ERIMEE, RCA
  phone: 0596592697
  phone ext: +596
  email: veronique.pelonde-erimee@chu-martinique.fr
  facility: 
  status: Recruiting
  contact: 
  country: Martinique
  responsible party type: Sponsor
  mesh term: Body Weight
  mesh term: Weight Loss
  mesh term: Weight Gain
  mesh term: Body Weight Changes