<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/NCT02202733</url>
  </required_header>
  <id_info>
    <org_study_id>2013-5379</org_study_id>
    <secondary_id>Eating Out</secondary_id>
    <nct_id>NCT02202733</nct_id>
  </id_info>
  <brief_title>Skill-based Cooking Intervention to Reduce Eating Out</brief_title>
  <official_title>A Caretaker Cooking Skills Intervention to Reduce Eating Out</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of the study is to use an iterative process to develop and refine a&#xD;
      skill-based cooking intervention to decrease the consumption of energy from foods prepared&#xD;
      away from home for evening meals, decrease energy intake, and promote a healthy weight in&#xD;
      parents and children aged 3-10 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I. Conduct 2-4 focus groups with 6-10 caretaker, who report eating foods prepared away&#xD;
      from home ≥3 times per week, per group to gain insight into current eating behaviors of foods&#xD;
      prepared away from home, current perceptions about a home prepared evening meal, and barriers&#xD;
      to preparing evening meals at home. Information gathered during Phase I will be used to&#xD;
      inform intervention development in Phase II.&#xD;
&#xD;
      Phase II. Develop, refine, and manualize a skill-based cooking intervention for&#xD;
      overweight/obese caretakers of a child aged 3-10 years. The aim of Phase II is to test the&#xD;
      feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared&#xD;
      away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast&#xD;
      food, take-out), energy intake from evening meals, and promote a healthy weight in parents&#xD;
      and children. Information collected during Phase I will inform the development of the&#xD;
      skill-based cooking intervention. Once developed, the intervention will be refined with 6&#xD;
      primary caretakers of a child, who meet criteria for being overweight/obese during a testing&#xD;
      phase. Conducting the intervention with at least six families will provide the opportunity&#xD;
      for further refinement of intervention procedures. The results will be important to&#xD;
      demonstrate feasibility for a future pilot randomized controlled trial that will test the&#xD;
      impact of a skill-based cooking intervention compared to a standard cooking demonstration&#xD;
      where recipes are simply provided to families.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary Intake (Phase II only)</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Caregivers will be asked to complete a 7-day dietary record of what they and their child eat at the evening meal. For each evening meal, the caretaker will be asked to describe the meal type (fast food, restaurant, pre-prepared frozen meal, or home prepared); the specific foods and drinks consumed, and the amount consumed by the child. Data from dietary records will be input into Nutrition Data System for Research (NDSR) software and analyzed for energy intake, percent energy from fat, and food groups (fruits, vegetables, grains, proteins, dairy) from the evening meal. Foods prepared away from home will be classified based on caretaker indication of fast food, restaurant, pre-prepared frozen meal, or home prepared on the dietary record.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caretaker Attitudes and Confidence</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Caretakers will report ease of providing foods prepared away from home (i.e., pre-prepared frozen meals, restaurant food, fast food, take-out) for an evening meal, ease of providing a home prepared evening meal, and their confidence with meal preparation using a 100-mm visual analog scale (VAS). Further caretakers will rate their ability, enjoyment of cooking and desire to cook on a 100-mm VAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Costs</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Caretakers will be provided with four visual images with each image showing one adult evening meal and two child evening meals. Caretaker will record the total cost of the meals shown in each image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Portions</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Caretakers will be provided with visual images of foods in different portion amounts and asked to identify which image best represents the amount their child would be served for dinner. Caretakers will also identify the images that best represent the amount they would serve themselves for dinner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dinner Choices</measure>
    <time_frame>0 and 10 weeks</time_frame>
    <description>Caretakers will complete a 10-question, open-ended questionnaire that solicits information related to choices of foods prepared away from home and foods prepared at home.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics</measure>
    <time_frame>0 adn 10 weeks</time_frame>
    <description>Height and weight will be measured using standard procedures.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Cooking</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A skill-based cooking intervention for caretakers of an overweight/obese child aged 3-10 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cooking</intervention_name>
    <description>The aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status.</description>
    <arm_group_label>Cooking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Phase I):&#xD;
&#xD;
          -  be ≥18 years of age&#xD;
&#xD;
          -  have a child between the ages of 3 and 10 years-old&#xD;
&#xD;
          -  report being the primary caretaker and have the primary feeding responsibility of the&#xD;
             child for dinner/supper&#xD;
&#xD;
          -  able to read, speak, and understand English&#xD;
&#xD;
          -  have transportation to the Medical Center&#xD;
&#xD;
          -  report their family including the child eats pre-prepared frozen food, restaurant&#xD;
             food, fast food, or take-out for dinner ≥3 times per week&#xD;
&#xD;
          -  has a working telephone number&#xD;
&#xD;
          -  is able to attend the scheduled date and time of a focus group.&#xD;
&#xD;
        Inclusion Criteria (Phase II):&#xD;
&#xD;
          -  caretaker is ≥18 years of age&#xD;
&#xD;
          -  caretaker is overweight or obese (BMI≥25)&#xD;
&#xD;
          -  has a child between the ages of 3 and 10 years-old&#xD;
&#xD;
          -  report being the primary caretaker and have the primary feeding responsibility of the&#xD;
             child for dinner/supper&#xD;
&#xD;
          -  caretaker is able to read, speak, and understand English&#xD;
&#xD;
          -  has transportation to the medical center and the instructional kitchen&#xD;
&#xD;
          -  does not plan to move out of the area before June 2015&#xD;
&#xD;
          -  reports their family including the child eats convenience food, restaurant food, fast&#xD;
             food, or take-out for dinner ≥3 times per week&#xD;
&#xD;
          -  reports access to a kitchen&#xD;
&#xD;
          -  able to attend the scheduled date and time of the sessions.&#xD;
&#xD;
        Exclusion Criteria (Phase II):&#xD;
&#xD;
          -  the caretaker or child is currently participating in a weight loss program and/or&#xD;
             taking weight loss medication&#xD;
&#xD;
          -  have a medical condition known to promote growth (e.g., Prader-Willi syndrome,&#xD;
             Cushing's syndrome) or had gastric bypass surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 13, 2015</last_update_submitted>
  <last_update_submitted_qc>July 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cooking skills</keyword>
  <keyword>eating out</keyword>
  <keyword>foods prepared away from home</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/NCT02202733
org study id: 2013-5379
secondary id: Eating Out
nct id: NCT02202733
lead sponsor: 
has dmc: No
The primary goal of the study is to use an iterative process to develop and refine a
      skill-based cooking intervention to decrease the consumption of energy from foods prepared
      away from home for evening meals, decrease energy intake, and promote a healthy weight in
      parents and children aged 3-10 years.
Phase I. Conduct 2-4 focus groups with 6-10 caretaker, who report eating foods prepared away
      from home ≥3 times per week, per group to gain insight into current eating behaviors of foods
      prepared away from home, current perceptions about a home prepared evening meal, and barriers
      to preparing evening meals at home. Information gathered during Phase I will be used to
      inform intervention development in Phase II.

      Phase II. Develop, refine, and manualize a skill-based cooking intervention for
      overweight/obese caretakers of a child aged 3-10 years. The aim of Phase II is to test the
      feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared
      away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast
      food, take-out), energy intake from evening meals, and promote a healthy weight in parents
      and children. Information collected during Phase I will inform the development of the
      skill-based cooking intervention. Once developed, the intervention will be refined with 6
      primary caretakers of a child, who meet criteria for being overweight/obese during a testing
      phase. Conducting the intervention with at least six families will provide the opportunity
      for further refinement of intervention procedures. The results will be important to
      demonstrate feasibility for a future pilot randomized controlled trial that will test the
      impact of a skill-based cooking intervention compared to a standard cooking demonstration
      where recipes are simply provided to families.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Dietary Intake (Phase II only)
time frame: 0 and 10 weeks
description: Caregivers will be asked to complete a 7-day dietary record of what they and their child eat at the evening meal. For each evening meal, the caretaker will be asked to describe the meal type (fast food, restaurant, pre-prepared frozen meal, or home prepared); the specific foods and drinks consumed, and the amount consumed by the child. Data from dietary records will be input into Nutrition Data System for Research (NDSR) software and analyzed for energy intake, percent energy from fat, and food groups (fruits, vegetables, grains, proteins, dairy) from the evening meal. Foods prepared away from home will be classified based on caretaker indication of fast food, restaurant, pre-prepared frozen meal, or home prepared on the dietary record.
measure: Caretaker Attitudes and Confidence
time frame: 0 and 10 weeks
description: Caretakers will report ease of providing foods prepared away from home (i.e., pre-prepared frozen meals, restaurant food, fast food, take-out) for an evening meal, ease of providing a home prepared evening meal, and their confidence with meal preparation using a 100-mm visual analog scale (VAS). Further caretakers will rate their ability, enjoyment of cooking and desire to cook on a 100-mm VAS.
measure: Food Costs
time frame: 0 and 10 weeks
description: Caretakers will be provided with four visual images with each image showing one adult evening meal and two child evening meals. Caretaker will record the total cost of the meals shown in each image.
measure: Portions
time frame: 0 and 10 weeks
description: Caretakers will be provided with visual images of foods in different portion amounts and asked to identify which image best represents the amount their child would be served for dinner. Caretakers will also identify the images that best represent the amount they would serve themselves for dinner.
measure: Dinner Choices
time frame: 0 and 10 weeks
description: Caretakers will complete a 10-question, open-ended questionnaire that solicits information related to choices of foods prepared away from home and foods prepared at home.
measure: Anthropometrics
time frame: 0 adn 10 weeks
description: Height and weight will be measured using standard procedures.
arm group label: Cooking
arm group type: Other
description: A skill-based cooking intervention for caretakers of an overweight/obese child aged 3-10 years.
intervention type: Other
intervention name: Cooking
description: The aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status.
arm group label: Cooking
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor