<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/NCT02215421</url>
  </required_header>
  <id_info>
    <org_study_id>H-33915</org_study_id>
    <secondary_id>R44HD075521</secondary_id>
    <nct_id>NCT02215421</nct_id>
  </id_info>
  <brief_title>Mommio: Training in Vegetable Parenting</brief_title>
  <official_title>Kiddio Food Fight: Training Parents in Effective Vegetable Parenting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Archimage, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Archimage, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 20 episode video game called Mommio simulates parent-child feeding interactions for parents&#xD;
      of 3-5 year old children within a storyline addressing a problem commonly reported by parents&#xD;
      (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the&#xD;
      vegetable), thereby training parents in effective food parenting practices. This research&#xD;
      evaluates whether the 20 episodes targeting barriers identified by parents across five levels&#xD;
      of difficulty influences vegetable parenting practices and children's dietary intake. We had&#xD;
      to discontinue the study since changes in commercial availability of game development&#xD;
      software required reprogramming and available funding did not allow for completion of game&#xD;
      programming. Thus, no game evaluation was possible.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Video games for parents that simulate interactions with a child using a narrative, offering&#xD;
      feedback on performance and goal setting for changing practices in the real world, and&#xD;
      addressing vegetable (V) feeding problems commonly reported by parents, may elicit desirable&#xD;
      cognitive, affective, and behavioral outcomes.&#xD;
&#xD;
      The rationale for training parents of preschool children in effective V parenting practices&#xD;
      is that: 1) parents have an important influence on young children's dietary intake; 2) child&#xD;
      dietary intake tracks into the adult years; and 3) high V consumption protects against&#xD;
      several chronic diseases later in life. Since parents of young children commonly complain&#xD;
      about not getting their child to eat V, there should be broad interest in playing Mommio.&#xD;
&#xD;
      A pre-post randomized clinical trial with 110 parents of 3-5 year olds who report having&#xD;
      difficulty getting their child to eat vegetables will be employed. The primary outcome will&#xD;
      be parent report of children's dietary intake; the secondary outcome will be use of V&#xD;
      parenting practices.&#xD;
&#xD;
      We had to discontinue the study since changes in commercial availability of game development&#xD;
      software required reprogramming and available funding did not allow for completion of game&#xD;
      programming. Thus, no game evaluation was possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding did not allow for completion of game programming&#xD;
  </why_stopped>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Parent Reported Child Vegetable FFQ</measure>
    <time_frame>One month from pre to post</time_frame>
    <description>To assess the preschool child's usual vegetable (V) intake, the participating parent will complete the V items from a 36 item FV screener which was demonstrated to have acceptable correlations with serum lycopene, lutein, cryptoxanthin, alphacarotene, and beta-carotene with a validity coefficient (r=0.35 with total carotenoids) comparable to the sum of three 24-hour dietary recalls. Parents have been shown to reliably and validly report preschool child diet intake. The response scales will be worded to reflect child's intake in the previous week. Item responses will be summed to estimate number of V servings consumed in the previous week. This questionnaire has been validated for parent report on children, and was sensitive to change.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Vegetable Parenting Practices Questionnaire</measure>
    <time_frame>One month from pre to post</time_frame>
    <description>Fruit and Vegetable Parenting Practices Questionnaire (FVPPQ), a parent-report questionnaire, includes 33 items associated with the effectiveness of parenting practices to get children to eat FV. Items will be scored on a three-point scale to indicate frequency of use of V parenting practices (1 - &quot;frequently&quot;, 2 - &quot;sometime&quot;, 3 - &quot;rarely-never&quot;). Internal consistency has been demonstrated. Helping HAND induced changes in these parenting practices.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative Interviews</measure>
    <time_frame>One month at post only</time_frame>
    <description>The intensive interviews will be conducted using a standardized script and commonly accepted procedures (e.g., 8-10 open ended questions, with follow up questions, prompts, and areas to probe). The questions will assess whether they attempted changes in their vegetable parenting practices with their 3-5 year old child, problems they encountered, what parents liked and disliked about the game, and how it could be made better. The parents' interviews will be about 30 minutes and audio tape recorded. Audio tapes will be transcribed verbatim and checked for accuracy prior to analysis. Following generally accepted qualitative data coding and analysis procedures, NVIVO, a qualitative software analysis program, will be utilized to facilitate data coding, retrieval, and analysis.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Play Mommio for 2 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, &quot;Totally Frobisher&quot; (providing backstory to the game), and play a game called Mommio (a &quot;casual&quot; video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No game play</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mommio</intervention_name>
    <description>The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, &quot;Totally Frobisher&quot; (providing backstory to the game), and play a game called Mommio (a &quot;casual&quot; video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store.</description>
    <arm_group_label>Play Mommio for 2 months</arm_group_label>
    <other_name>Kiddio: Food Fight</other_name>
    <other_name>Kiddia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being a parent of a child 3-5 years old&#xD;
&#xD;
          -  willing to complete all measures&#xD;
&#xD;
          -  having an iPhone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the parent not speaking English (since the games are in English alone, due to budget&#xD;
             constraints);&#xD;
&#xD;
          -  having a 3-5 year old child with a medical condition that influences diet; or&#xD;
&#xD;
          -  a parent with an illness that impairs the ability to complete questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Buday, FAIA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Archimage, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Beltran A, O'Connor T, Hughes S, Baranowski J, Nicklas TA, Thompson D, Baranowski T. Alpha Test of a Videogame to Increase Children's Vegetable Consumption. Games Health J. 2012 Jun;1(3):219-222. doi: 10.1089/g4h.2011.0027.</citation>
    <PMID>24761315</PMID>
  </reference>
  <reference>
    <citation>Baranowski T, O'Connor T, Hughes S, Beltran A, Baranowski J, Nicklas T, Sleddens E, Thompson D, Lu AS, Buday R. Smart phone video game simulation of parent-child interactions: Learning skills for effective vegetable parenting. In: Arnab S, Dunwell I, Debattista K (Eds). Serious Games for Healthcare: Applications and Implications. Hershey, PA: IGI Global, 2012, 248-265.</citation>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vegetables</keyword>
  <keyword>dietary intake</keyword>
  <keyword>preschoolers</keyword>
  <keyword>parents</keyword>
  <keyword>video game</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/NCT02215421
org study id: H-33915
secondary id: R44HD075521
nct id: NCT02215421
lead sponsor: 
collaborator: 
has dmc: No
A 20 episode video game called Mommio simulates parent-child feeding interactions for parents
      of 3-5 year old children within a storyline addressing a problem commonly reported by parents
      (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the
      vegetable), thereby training parents in effective food parenting practices. This research
      evaluates whether the 20 episodes targeting barriers identified by parents across five levels
      of difficulty influences vegetable parenting practices and children's dietary intake. We had
      to discontinue the study since changes in commercial availability of game development
      software required reprogramming and available funding did not allow for completion of game
      programming. Thus, no game evaluation was possible.
Video games for parents that simulate interactions with a child using a narrative, offering
      feedback on performance and goal setting for changing practices in the real world, and
      addressing vegetable (V) feeding problems commonly reported by parents, may elicit desirable
      cognitive, affective, and behavioral outcomes.

      The rationale for training parents of preschool children in effective V parenting practices
      is that: 1) parents have an important influence on young children's dietary intake; 2) child
      dietary intake tracks into the adult years; and 3) high V consumption protects against
      several chronic diseases later in life. Since parents of young children commonly complain
      about not getting their child to eat V, there should be broad interest in playing Mommio.

      A pre-post randomized clinical trial with 110 parents of 3-5 year olds who report having
      difficulty getting their child to eat vegetables will be employed. The primary outcome will
      be parent report of children's dietary intake; the secondary outcome will be use of V
      parenting practices.

      We had to discontinue the study since changes in commercial availability of game development
      software required reprogramming and available funding did not allow for completion of game
      programming. Thus, no game evaluation was possible.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in Parent Reported Child Vegetable FFQ
time frame: One month from pre to post
description: To assess the preschool child's usual vegetable (V) intake, the participating parent will complete the V items from a 36 item FV screener which was demonstrated to have acceptable correlations with serum lycopene, lutein, cryptoxanthin, alphacarotene, and beta-carotene with a validity coefficient (r=0.35 with total carotenoids) comparable to the sum of three 24-hour dietary recalls. Parents have been shown to reliably and validly report preschool child diet intake. The response scales will be worded to reflect child's intake in the previous week. Item responses will be summed to estimate number of V servings consumed in the previous week. This questionnaire has been validated for parent report on children, and was sensitive to change.
measure: Change in Vegetable Parenting Practices Questionnaire
time frame: One month from pre to post
description: Fruit and Vegetable Parenting Practices Questionnaire (FVPPQ), a parent-report questionnaire, includes 33 items associated with the effectiveness of parenting practices to get children to eat FV. Items will be scored on a three-point scale to indicate frequency of use of V parenting practices (1 - "frequently", 2 - "sometime", 3 - "rarely-never"). Internal consistency has been demonstrated. Helping HAND induced changes in these parenting practices.
measure: Qualitative Interviews
time frame: One month at post only
description: The intensive interviews will be conducted using a standardized script and commonly accepted procedures (e.g., 8-10 open ended questions, with follow up questions, prompts, and areas to probe). The questions will assess whether they attempted changes in their vegetable parenting practices with their 3-5 year old child, problems they encountered, what parents liked and disliked about the game, and how it could be made better. The parents' interviews will be about 30 minutes and audio tape recorded. Audio tapes will be transcribed verbatim and checked for accuracy prior to analysis. Following generally accepted qualitative data coding and analysis procedures, NVIVO, a qualitative software analysis program, will be utilized to facilitate data coding, retrieval, and analysis.
arm group label: Play Mommio for 2 months
arm group type: Experimental
description: The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, "Totally Frobisher" (providing backstory to the game), and play a game called Mommio (a "casual" video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store.
arm group label: No game play
arm group type: No Intervention
description: No intervention control.
intervention type: Behavioral
intervention name: Mommio
description: The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, "Totally Frobisher" (providing backstory to the game), and play a game called Mommio (a "casual" video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store.
arm group label: Play Mommio for 2 months
other name: Kiddio: Food Fight
other name: Kiddia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Buday, FAIA
role: Principal Investigator
affiliation: Archimage, Inc.
facility: 
country: United States
citation: Beltran A, O'Connor T, Hughes S, Baranowski J, Nicklas TA, Thompson D, Baranowski T. Alpha Test of a Videogame to Increase Children's Vegetable Consumption. Games Health J. 2012 Jun;1(3):219-222. doi: 10.1089/g4h.2011.0027.
PMID: 24761315
citation: Baranowski T, O'Connor T, Hughes S, Beltran A, Baranowski J, Nicklas T, Sleddens E, Thompson D, Lu AS, Buday R. Smart phone video game simulation of parent-child interactions: Learning skills for effective vegetable parenting. In: Arnab S, Dunwell I, Debattista K (Eds). Serious Games for Healthcare: Applications and Implications. Hershey, PA: IGI Global, 2012, 248-265.
responsible party type: Sponsor