<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/NCT03798808</url>
  </required_header>
  <id_info>
    <org_study_id>NUTRIATHLON-2015-259 R-2</org_study_id>
    <nct_id>NCT03798808</nct_id>
  </id_info>
  <brief_title>Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children</brief_title>
  <official_title>The Impact of an Innovative Family and Web-based Nutrition Intervention to Increase Vegetable, Fruit, and Dairy Intakes in Children With Overweight or Obesity: A Single-blinded Randomized Family Clustered Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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>
      Considering the high prevalence of childhood obesity worldwide, effective interventions are&#xD;
      needed . Parental involvement in interventions and the use of web-based modalities appear to&#xD;
      be promising approaches. The aim of the study was to evaluate the efficacy of an innovative&#xD;
      family and Web-based nutrition intervention called &quot;Family Nutriathlon&quot; on consumption of&#xD;
      vegetables and fruit and dairy products and/or alternatives and on diet quality among&#xD;
      children and their parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty-three families, with at least one child with a BMI &gt;85th percentile, participated in&#xD;
      either the intervention (n=24) or control group (n=19) over an 8-week period. Families in the&#xD;
      intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to&#xD;
      increase their consumption and variety of fruits and vegetables and dairy products by&#xD;
      recording their daily intakes using a Web-based platform. Families in the control group&#xD;
      received recommendations based on general nutrition guidelines. Three follow-ups with a&#xD;
      dietitian once every two weeks via Skype to assess progress were scheduled. A three-day food&#xD;
      record was completed at baseline (week 0), immediately after (week 8) and 6 months after the&#xD;
      intervention. A two-way repeated measures analysis of variance was used to assess changes in&#xD;
      consumption of fruits and vegetables and dairy products, diet quality and dietary intakes&#xD;
      between groups and over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary intakes and diet quality</measure>
    <time_frame>8 weeks</time_frame>
    <description>Fruit, vegetable and dairy product consumption and diet quality as measured by the Nutrient-Rich Foods Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>Weeks 0, 9 and 18-36 (follow-up)</time_frame>
    <description>Body weight, height and body mass index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Diet Habit</condition>
  <arm_group>
    <arm_group_label>Family Nutriathlon group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Web-based nutrition program (encouraging consumption of fruits, vegetables and dairy products through an online platform)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>General nutrition guidelines (e.g. following Canada's Food Guide)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Consumption of fruits, vegetables and dairy products</intervention_name>
    <description>Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption.</description>
    <arm_group_label>Family Nutriathlon group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        All inclusion/exclusion criterion were the same between the two projects (including the&#xD;
        intervention) except for the inclusion of a child living with obesity or overweight.&#xD;
&#xD;
        Children were aged between 8 and 16 years, but there was no age limit for parents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Vicky Drapeau</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>vegetables, fruits, dairy, children, habits</keyword>
  <!-- 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/NCT03798808
org study id: NUTRIATHLON-2015-259 R-2
nct id: NCT03798808
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Considering the high prevalence of childhood obesity worldwide, effective interventions are
      needed . Parental involvement in interventions and the use of web-based modalities appear to
      be promising approaches. The aim of the study was to evaluate the efficacy of an innovative
      family and Web-based nutrition intervention called "Family Nutriathlon" on consumption of
      vegetables and fruit and dairy products and/or alternatives and on diet quality among
      children and their parents.
Forty-three families, with at least one child with a BMI >85th percentile, participated in
      either the intervention (n=24) or control group (n=19) over an 8-week period. Families in the
      intervention (Family Nutriathlon) will participated in a nutrition challenge that aimed to
      increase their consumption and variety of fruits and vegetables and dairy products by
      recording their daily intakes using a Web-based platform. Families in the control group
      received recommendations based on general nutrition guidelines. Three follow-ups with a
      dietitian once every two weeks via Skype to assess progress were scheduled. A three-day food
      record was completed at baseline (week 0), immediately after (week 8) and 6 months after the
      intervention. A two-way repeated measures analysis of variance was used to assess changes in
      consumption of fruits and vegetables and dairy products, diet quality and dietary intakes
      between groups and over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Dietary intakes and diet quality
time frame: 8 weeks
description: Fruit, vegetable and dairy product consumption and diet quality as measured by the Nutrient-Rich Foods Index
measure: Anthropometric measurements
time frame: Weeks 0, 9 and 18-36 (follow-up)
description: Body weight, height and body mass index
arm group label: Family Nutriathlon group
arm group type: Experimental
description: Web-based nutrition program (encouraging consumption of fruits, vegetables and dairy products through an online platform)
arm group label: Control group
arm group type: No Intervention
description: General nutrition guidelines (e.g. following Canada's Food Guide)
intervention type: Other
intervention name: Consumption of fruits, vegetables and dairy products
description: Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption.
arm group label: Family Nutriathlon group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Vicky Drapeau
investigator title: Professor