<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/NCT04463407</url>
  </required_header>
  <id_info>
    <org_study_id>BIOEPUCV-H145-2017</org_study_id>
    <nct_id>NCT04463407</nct_id>
  </id_info>
  <brief_title>Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity</brief_title>
  <official_title>Efectividad de Una intervención Educativa Preventiva Previa a Vacaciones de Fiestas Patrias Sobre la composición Corporal, hábitos de alimentación y Niveles de Actividad física en Estudiantes Universitarios: Estudio Aleatorizado Controlado</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pontificia Universidad Catolica de Valparaiso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pontificia Universidad Catolica de Valparaiso</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aimed to investigate the effects of a single nutritional preventive session&#xD;
      previous to a critical period linked to fat gain in university students with overweight and&#xD;
      obesity, emulating a nutritional session of a public health system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">September 27, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body composition measurements</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes on fat mass measured by DXA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feeding questionnaires and food guide recommendations</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes on the Global Food Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feeding questionnaires and food guide recommendations</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes on the KIDMED index (questionnaire establishes the adherence to the Mediterranean diet)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feeding questionnaires and food guide recommendations</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes on the Food Guide Recommendation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>3 weeks</time_frame>
    <description>Modification on physical activity level measured by accelerometry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants keep their normal routine without intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive a single nutritional intervention previous to a critical period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students</intervention_name>
    <description>An intervention was performed emulating a traditional nutritional session from a primary healthcare center (public health system). Traditionally, this session lasts around 20 minutes and includes a body composition measurement, nutritional assessment, and a brief educational talk about healthy eating. Just the intervention group received a series of healthy recommendations specially focused on the National Holiday.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index [BMI] ≥25 kg/m2&#xD;
&#xD;
          -  Not having metal plates&#xD;
&#xD;
          -  Not studying Nutrition and Dietetics or Physical Education&#xD;
&#xD;
          -  Not being pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Presente gastrointestinal problems (vomit or diarrheas) during the three weeks that last&#xD;
        the experiment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile</name>
      <address>
        <city>Valparaíso</city>
        <state>Valparaiso</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pontificia Universidad Catolica de Valparaiso</investigator_affiliation>
    <investigator_full_name>Carlos Cristi Montero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All participant data are private.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04463407/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04463407
org study id: BIOEPUCV-H145-2017
nct id: NCT04463407
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The present study aimed to investigate the effects of a single nutritional preventive session
      previous to a critical period linked to fat gain in university students with overweight and
      obesity, emulating a nutritional session of a public health system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Body composition measurements
time frame: 3 weeks
description: Changes on fat mass measured by DXA
measure: Feeding questionnaires and food guide recommendations
time frame: 3 weeks
description: Changes on the Global Food Index
measure: Feeding questionnaires and food guide recommendations
time frame: 3 weeks
description: Changes on the KIDMED index (questionnaire establishes the adherence to the Mediterranean diet)
measure: Feeding questionnaires and food guide recommendations
time frame: 3 weeks
description: Changes on the Food Guide Recommendation
measure: Physical activity level
time frame: 3 weeks
description: Modification on physical activity level measured by accelerometry
arm group label: Control group
arm group type: No Intervention
description: Participants keep their normal routine without intervention.
arm group label: Experimental group
arm group type: Experimental
description: Participants receive a single nutritional intervention previous to a critical period.
intervention type: Other
intervention name: Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students
description: An intervention was performed emulating a traditional nutritional session from a primary healthcare center (public health system). Traditionally, this session lasts around 20 minutes and includes a body composition measurement, nutritional assessment, and a brief educational talk about healthy eating. Just the intervention group received a series of healthy recommendations specially focused on the National Holiday.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: Pontificia Universidad Catolica de Valparaiso
investigator full name: Carlos Cristi Montero
investigator title: Principal Investigator
mesh term: Obesity
sharing ipd: No
ipd description: All participant data are private.
provided document: 