<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/NCT02258802</url>
  </required_header>
  <id_info>
    <org_study_id>102014-CIE</org_study_id>
    <nct_id>NCT02258802</nct_id>
  </id_info>
  <brief_title>Pilot Psychoeducational Intervention Model to Improve Nutritional Status in Low Resource Settings</brief_title>
  <official_title>A Psychoeducational Intervention Model in Nutrition to Improve Nutritional Status in a Pilot Low Resource Population in the City of Saltillo, Coahuila Mexico.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Monterrey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FEMSA Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Monterrey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop, implement and evaluate a psychoeducational&#xD;
      intervention focused to improve nutritional status, specifically micronutrients, of mothers&#xD;
      and caregivers of children between the ages of 5 and 13 years and their children through&#xD;
      providing healthy cooking lessons in their communities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mexico's malnutrition problem goes beyond lack of food. Nutrition transition in our country&#xD;
      has modified dietary patterns in a way that now we observe more and more a decrease in&#xD;
      consumption of micronutrient rich foods, like vegetables, and an increase in consumption of&#xD;
      high energy-dense foods with low content of micronutrients (highly processed foods). In&#xD;
      Mexico, over 70% of the population presents an inadequate vegetable intake, with a higher&#xD;
      prevalence in scholars (5 - 11 years), where only 17% of them consume &gt;50% of the recommended&#xD;
      vegetable intake. A vegetable poor diet is related to malnutrition, poor cognitive&#xD;
      development and low physical performance. Added to this, Mexican families have lost the&#xD;
      tradition of cooking at home. It is well known that different factors contribute to a&#xD;
      population's diet and cooking at home as well as eating with the family have been identified&#xD;
      as fundamental factors to promote a healthy diet. Therefore, the aim of this&#xD;
      psychoeducational intervention in nutrition is to improve nutritional status in families,&#xD;
      particularly mothers and caregivers of children between the ages of 5 and 13 years and their&#xD;
      children through providing healthy cooking lessons in their communities where the optimal&#xD;
      preparation and use of local foods based on vegetables is promoted at the same time the&#xD;
      importance of cooking at home and eating as a family is highlighted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in food knowledge and behaviour</measure>
    <time_frame>baseline, 6 months, 1 year</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in vegetable intake</measure>
    <time_frame>baseline, 1 year</time_frame>
    <description>24 hour recall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dietary practices</measure>
    <time_frame>baseline, 6 months, 1 year</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food waste</measure>
    <time_frame>baseline, 6 months, 1 year</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive development in children</measure>
    <time_frame>baseline, 1 year</time_frame>
    <description>questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anthropometry</measure>
    <time_frame>baseline, 6 months, 1 year</time_frame>
    <description>weight, height and waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in micronutrient status</measure>
    <time_frame>baseline, 1 year</time_frame>
    <description>serum sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammatory markers</measure>
    <time_frame>baseline, 1 year</time_frame>
    <description>serum sample</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Child Malnutrition</condition>
  <condition>Child Overnutrition</condition>
  <condition>Malnutrition in Children</condition>
  <condition>Malnutrition, Child</condition>
  <condition>Nutrition Disorders, Child</condition>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Psychoeducational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual food practices</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These are participants from the communities where the intervention is active but are not attending the cooking lessons.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducational intervention</intervention_name>
    <description>A mobile kitchen visits the 5 selected communities every 2 weeks for a period of 1 year. A 30 minute cooking lesson is given by a trained instructor, the recipes have been designed to be quick and easy to make, use local and inexpensive ingredients, contain mostly vegetables and have a good taste. During the lesson, healthy habit and cooking tips are mentioned. A printed version of the recipe is given to every participant. Every lesson a different participant is encouraged to help prepare the recipe. At the end of the lesson all the participants get to taste the meal and express their opinion.</description>
    <arm_group_label>Psychoeducational intervention</arm_group_label>
    <other_name>Psychoeducational intervention in nutrition</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 60 years&#xD;
&#xD;
          -  Premenopausal&#xD;
&#xD;
          -  BMI &lt; 45 during enrollment&#xD;
&#xD;
          -  Apparently healthy&#xD;
&#xD;
          -  With a child in her care between the ages of 5 and 13 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  With a hysterectomy in the past 3 months&#xD;
&#xD;
          -  Alcohol consumption &gt; 14 drinks a week&#xD;
&#xD;
          -  Use of vitamin supplements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Carla Cepeda-Lopez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Monterrey</affiliation>
  </overall_official>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychoeducational intervention</keyword>
  <keyword>nutrition intervention</keyword>
  <keyword>malnutrition</keyword>
  <keyword>micronutrient deficiency</keyword>
  <keyword>nutrition transition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Child Nutrition Disorders</mesh_term>
    <mesh_term>Overnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02258802
org study id: 102014-CIE
nct id: NCT02258802
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to develop, implement and evaluate a psychoeducational
      intervention focused to improve nutritional status, specifically micronutrients, of mothers
      and caregivers of children between the ages of 5 and 13 years and their children through
      providing healthy cooking lessons in their communities.
Mexico's malnutrition problem goes beyond lack of food. Nutrition transition in our country
      has modified dietary patterns in a way that now we observe more and more a decrease in
      consumption of micronutrient rich foods, like vegetables, and an increase in consumption of
      high energy-dense foods with low content of micronutrients (highly processed foods). In
      Mexico, over 70% of the population presents an inadequate vegetable intake, with a higher
      prevalence in scholars (5 - 11 years), where only 17% of them consume >50% of the recommended
      vegetable intake. A vegetable poor diet is related to malnutrition, poor cognitive
      development and low physical performance. Added to this, Mexican families have lost the
      tradition of cooking at home. It is well known that different factors contribute to a
      population's diet and cooking at home as well as eating with the family have been identified
      as fundamental factors to promote a healthy diet. Therefore, the aim of this
      psychoeducational intervention in nutrition is to improve nutritional status in families,
      particularly mothers and caregivers of children between the ages of 5 and 13 years and their
      children through providing healthy cooking lessons in their communities where the optimal
      preparation and use of local foods based on vegetables is promoted at the same time the
      importance of cooking at home and eating as a family is highlighted.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in food knowledge and behaviour
time frame: baseline, 6 months, 1 year
description: questionnaire
measure: Change in vegetable intake
time frame: baseline, 1 year
description: 24 hour recall
measure: Change in dietary practices
time frame: baseline, 6 months, 1 year
description: questionnaire
measure: Change in food waste
time frame: baseline, 6 months, 1 year
description: questionnaire
measure: Change in cognitive development in children
time frame: baseline, 1 year
description: questionnaire
measure: Change in anthropometry
time frame: baseline, 6 months, 1 year
description: weight, height and waist circumference
measure: Change in micronutrient status
time frame: baseline, 1 year
description: serum sample
measure: Change in inflammatory markers
time frame: baseline, 1 year
description: serum sample
arm group label: Psychoeducational intervention
arm group type: Experimental
description: Participants will be receiving a cooking lesson in their community every 2 weeks for 1 year.
arm group label: Usual food practices
arm group type: No Intervention
description: These are participants from the communities where the intervention is active but are not attending the cooking lessons.
intervention type: Behavioral
intervention name: Psychoeducational intervention
description: A mobile kitchen visits the 5 selected communities every 2 weeks for a period of 1 year. A 30 minute cooking lesson is given by a trained instructor, the recipes have been designed to be quick and easy to make, use local and inexpensive ingredients, contain mostly vegetables and have a good taste. During the lesson, healthy habit and cooking tips are mentioned. A printed version of the recipe is given to every participant. Every lesson a different participant is encouraged to help prepare the recipe. At the end of the lesson all the participants get to taste the meal and express their opinion.
arm group label: Psychoeducational intervention
other name: Psychoeducational intervention in nutrition
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ana Carla Cepeda-Lopez, PhD
role: Principal Investigator
affiliation: Universidad de Monterrey
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Nutrition Disorders
mesh term: Child Nutrition Disorders
mesh term: Overnutrition
sharing ipd: No