<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/NCT01710423</url>
  </required_header>
  <id_info>
    <org_study_id>12-009579</org_study_id>
    <nct_id>NCT01710423</nct_id>
  </id_info>
  <brief_title>Peer-mentored Cooking Classes for Parents of Toddlers: Do Families Cook More and Eat Healthier After the Intervention?</brief_title>
  <official_title>Improving Home Food Preparation Practices Among Families With Young Children: A Peer Mentoring Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to test the effectiveness of a community-located, peer mentored intervention&#xD;
      to improve home food preparation practices in families with young children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Barriers to healthy eating and active living are at the heart of the obesity epidemic. This&#xD;
      study focuses on a key factor underlying healthy eating: home food preparation. Preparing&#xD;
      food at home entails a sequence of steps from obtaining food, to planning and cooking or&#xD;
      preparing meals, to finally serving and eating the meal. Many strategies to curb obesity in&#xD;
      children focus on eliminating processed and fast food from the diet, as well as improving&#xD;
      access to fresh produce and other healthy ingredients. A collective ability to regularly and&#xD;
      reliably prepare healthy food at home is implicit in these and other prevention strategies.&#xD;
      Little research, however, has grappled with the phenomenon that there has been a generational&#xD;
      loss of home food preparation ability over the past few decades. What is urgently needed is&#xD;
      to design effective, enticing, and scalable interventions to improve home food preparation&#xD;
      practices across diverse groups.&#xD;
&#xD;
      This study aims to test the effectiveness of a community-located, peer mentored intervention&#xD;
      to improve home food preparation practices in families with young children. The investigators&#xD;
      will partner with Children's Hospital of Philadelphia Early Head Start, a community-based&#xD;
      organization serving families with children ages 0 to 3 years in West Philadelphia, aiming&#xD;
      specifically to:&#xD;
&#xD;
        1. Use the principles of Community Based Participatory Research (CBPR) to design, evaluate&#xD;
           and disseminate a peer mentored intervention aimed at improving home food preparation&#xD;
           practices among families with young children.&#xD;
&#xD;
        2. Conduct a randomized controlled trial with a delayed entry control group to test the&#xD;
           effect of the intervention on three outcomes: home food preparation practices,&#xD;
           healthfulness of the diet, and cooking-related self-efficacy.&#xD;
&#xD;
      The investigators hypothesize that families participating in this intervention will&#xD;
      demonstrate improvement in parental self-efficacy related to cooking, home food preparation&#xD;
      practices, and the healthfulness of parents' and toddlers' diets post-intervention, compared&#xD;
      to families who do not participate in the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food Frequency Questionnaire</measure>
    <time_frame>23 weeks from Baseline</time_frame>
    <description>The primary outcome will be the change in healthfulness of the diet as measured by food frequency questionnaires for participants through the course of the study. Study staff will meet with each participant and ask them to answer questions about the frequency of their food and beverage consumption over the course of a 12 month period. The results will be analyzed for consumption of specific food-groups (fruits, vegetables, whole grains, dairy, etc.). The primary endpoint is the difference in the healthfulness of the diet between the immediate intervention group and the control group at week 23.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cooking-related self-efficacy</measure>
    <time_frame>23 weeks from Baseline</time_frame>
    <description>Self-efficacy related to cooking will be measured using a 25-item instrument. We will assess to assess the difference between the immediate intervention group and the control group at week 23.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home food preparation practices</measure>
    <time_frame>23 weeks from Baseline</time_frame>
    <description>Home food preparation practices will be measured using questions from the National Health and Nutrition Examination Survey. We will measure the difference in home food preparation practices between the immediate intervention group and the control group at week 23.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>41 weeks from Baseline</time_frame>
    <description>We will measure the change in parent and child body mass index before and after the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Immediate Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peer mentoring intervention ('Cooking with Friends')</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Entry Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer mentoring intervention ('Cooking with Friends')</intervention_name>
    <description>'Cooking with Friends' is a community-located, peer mentoring intervention aimed at improving home food preparation practices in families with young children.&#xD;
The intervention was developed in an iterative, community-based research approach, and will be conducted in partnership with Early Head Start (EHS) at The Children's Hospital of Philadelphia. Cooking with Friends builds on existing monthly cooking classes at EHS that have proven popular with EHS families. Through 5 weekly classes, this intervention will explore topics of how to prepare healthy foods at home.&#xD;
The peer mentoring component is a novel innovation to this intervention. The intervention pairs peer mentors to individual mentees in a community setting, to effect behavioral change among caregivers of young children.</description>
    <arm_group_label>Immediate Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Mentee Inclusion Criteria:&#xD;
&#xD;
          1. Eligible mentees will be caregivers of 0-3 year old children who are enrolled in Early&#xD;
             Head Start at The Children's Hospital of Philadelphia (CHOP EHS) at the time of&#xD;
             recruitment.&#xD;
&#xD;
          2. Caregiver enrollment in CHOP EHS requires the following:&#xD;
&#xD;
               1. Children are 0-3 years old (Expectant mothers are also eligible to enroll)&#xD;
&#xD;
               2. The family has an income at or below federal poverty level&#xD;
&#xD;
               3. The family lives in West Philadelphia, within the geographic area served by CHOP&#xD;
                  EHS.&#xD;
&#xD;
          3. Caregiver is able to give informed consent.&#xD;
&#xD;
        Mentor Inclusion Criteria:&#xD;
&#xD;
          1. Eligible peer mentors should meet the inclusion criteria set for above for mentees.&#xD;
&#xD;
          2. The study team, in conjunction with EHS staff, will decide which participants will be&#xD;
             invited to be peer mentors, based on attributes including interest, leadership&#xD;
             ability, and home food preparation skills.&#xD;
&#xD;
        Children Inclusion Criteria:&#xD;
&#xD;
          1. 0-3 year old children of mentee caregivers enrolled in the study&#xD;
&#xD;
          2. If a mentee caregiver has more than one child currently enrolled in CHOP EHS, then all&#xD;
             their eligible children will be enrolled in the study.&#xD;
&#xD;
          3. If there are expectant mothers who are enrolled as mentees, their children will be&#xD;
             enrolled in the study upon delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Caregivers and children not meeting the inclusion criteria above.&#xD;
&#xD;
          2. Subjects who, in the opinion of the Investigator, may be unable to participate in the&#xD;
             study schedules or procedures.&#xD;
&#xD;
          3. Children of peer mentors will not be eligible for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Senbagam Virudachalam, MD, MSHP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>February 4, 2015</last_update_submitted>
  <last_update_submitted_qc>February 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Home Food Preparation</keyword>
  <keyword>Peer Mentoring</keyword>
  <keyword>Early Head Start</keyword>
  <keyword>Cooking</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT01710423
org study id: 12-009579
nct id: NCT01710423
lead sponsor: 
has dmc: No
This study aims to test the effectiveness of a community-located, peer mentored intervention
      to improve home food preparation practices in families with young children.
Barriers to healthy eating and active living are at the heart of the obesity epidemic. This
      study focuses on a key factor underlying healthy eating: home food preparation. Preparing
      food at home entails a sequence of steps from obtaining food, to planning and cooking or
      preparing meals, to finally serving and eating the meal. Many strategies to curb obesity in
      children focus on eliminating processed and fast food from the diet, as well as improving
      access to fresh produce and other healthy ingredients. A collective ability to regularly and
      reliably prepare healthy food at home is implicit in these and other prevention strategies.
      Little research, however, has grappled with the phenomenon that there has been a generational
      loss of home food preparation ability over the past few decades. What is urgently needed is
      to design effective, enticing, and scalable interventions to improve home food preparation
      practices across diverse groups.

      This study aims to test the effectiveness of a community-located, peer mentored intervention
      to improve home food preparation practices in families with young children. The investigators
      will partner with Children's Hospital of Philadelphia Early Head Start, a community-based
      organization serving families with children ages 0 to 3 years in West Philadelphia, aiming
      specifically to:

        1. Use the principles of Community Based Participatory Research (CBPR) to design, evaluate
           and disseminate a peer mentored intervention aimed at improving home food preparation
           practices among families with young children.

        2. Conduct a randomized controlled trial with a delayed entry control group to test the
           effect of the intervention on three outcomes: home food preparation practices,
           healthfulness of the diet, and cooking-related self-efficacy.

      The investigators hypothesize that families participating in this intervention will
      demonstrate improvement in parental self-efficacy related to cooking, home food preparation
      practices, and the healthfulness of parents' and toddlers' diets post-intervention, compared
      to families who do not participate in the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Food Frequency Questionnaire
time frame: 23 weeks from Baseline
description: The primary outcome will be the change in healthfulness of the diet as measured by food frequency questionnaires for participants through the course of the study. Study staff will meet with each participant and ask them to answer questions about the frequency of their food and beverage consumption over the course of a 12 month period. The results will be analyzed for consumption of specific food-groups (fruits, vegetables, whole grains, dairy, etc.). The primary endpoint is the difference in the healthfulness of the diet between the immediate intervention group and the control group at week 23.
measure: Cooking-related self-efficacy
time frame: 23 weeks from Baseline
description: Self-efficacy related to cooking will be measured using a 25-item instrument. We will assess to assess the difference between the immediate intervention group and the control group at week 23.
measure: Home food preparation practices
time frame: 23 weeks from Baseline
description: Home food preparation practices will be measured using questions from the National Health and Nutrition Examination Survey. We will measure the difference in home food preparation practices between the immediate intervention group and the control group at week 23.
measure: Body mass index
time frame: 41 weeks from Baseline
description: We will measure the change in parent and child body mass index before and after the intervention.
arm group label: Immediate Intervention
arm group type: Experimental
description: Peer mentoring intervention ('Cooking with Friends')
arm group label: Delayed Entry Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Peer mentoring intervention ('Cooking with Friends')
description: 'Cooking with Friends' is a community-located, peer mentoring intervention aimed at improving home food preparation practices in families with young children.
The intervention was developed in an iterative, community-based research approach, and will be conducted in partnership with Early Head Start (EHS) at The Children's Hospital of Philadelphia. Cooking with Friends builds on existing monthly cooking classes at EHS that have proven popular with EHS families. Through 5 weekly classes, this intervention will explore topics of how to prepare healthy foods at home.
The peer mentoring component is a novel innovation to this intervention. The intervention pairs peer mentors to individual mentees in a community setting, to effect behavioral change among caregivers of young children.
arm group label: Immediate Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Senbagam Virudachalam, MD, MSHP
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity