xml: <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/NCT05994924</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00078071</org_study_id>
      <nct_id>NCT05994924</nct_id>
    </id_info>
    <brief_title>Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children</brief_title>
    <acronym>STORY</acronym>
    <official_title>A Pilot Randomized Controlled Trial Using Storytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wake Forest University Health Sciences</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this qualitative trial study is to assess the usefulness and acceptability of the&#xD;
        intervention in diverse clinical and community settings. The main questions it aims to answer&#xD;
        are:&#xD;
  &#xD;
          -  How many parents were approached and consented to participate?&#xD;
  &#xD;
          -  How many parents viewed the videos via link versus viewed the video with a discussion in&#xD;
             group sessions?&#xD;
  &#xD;
          -  How did parents feel about the process of being recruited and interventions that they&#xD;
             participated in?&#xD;
  &#xD;
          -  How did the providers feel about the intervention recruitment and delivery?&#xD;
  &#xD;
          -  How did the facilitators feel about their delivery of the material? Participants will&#xD;
             complete a survey and an interview after completing second part of the intervention.&#xD;
  &#xD;
        Researchers will compare handout, online-only video, and group class interventions to see if&#xD;
        an intervention delivery is useful and accepted by parents or providers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a pilot randomized trial to assess feasibility and acceptability of STORY. The study&#xD;
        will recruit 30 parents. Parents will complete a questionnaire and dyad's heights and weights&#xD;
        will be measured. Families will be randomized to the control group or 1 of 2 intervention&#xD;
        delivery approaches (IA). Parents will be given a handout (controls), links to the videos to&#xD;
        watch independently (IA 1), or information on how they will be contacted to schedule their&#xD;
        intervention sessions (IAs 2). After 2 video/sessions, all parents will complete a written&#xD;
        survey assessing their experience with the intervention and any change same at home; the&#xD;
        written survey will reassess baseline measures. Intervention parents will also complete a&#xD;
        semi-structured interview to assess the family's experience with the STORY trial.&#xD;
  &#xD;
        Sub aim 2a: Feasibility: number of parents approached, number of parents consented Sub aim&#xD;
        2b: Adherence: number of parents who complete videos or sessions Sub aim 2c: Acceptability to&#xD;
        parents and providers&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Number of Parents Approached</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of parents who are approached for participation at 3 primary care offices.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Parents Consented</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of parents that consented to participating in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Parents who Viewed Videos Provided by Provider</measure>
      <time_frame>Month 2</time_frame>
      <description>tracking the number of videos viewed by each parent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Parents who Complete In-Person Group Sessions</measure>
      <time_frame>Month 2</time_frame>
      <description>tracking the number of sessions attended by each parent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Parent Acceptance of Intervention - Percent of parents</measure>
      <time_frame>Month 4</time_frame>
      <description>Measure parent acceptability of intervention using brief survey and semi-structured interview responses - Percent of parents who respond on the survey that the intervention was acceptable or completely acceptable to them</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provider Acceptance of Intervention - Percent of providers</measure>
      <time_frame>Month 4</time_frame>
      <description>Measure provider acceptability using a short survey - Percent of providers who respond on the survey that the intervention was acceptable or completely acceptable to them</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Facilitator Acceptance of Intervention - Percent of facilitators</measure>
      <time_frame>Month 4</time_frame>
      <description>Measure facilitator acceptability using semi-structured interviews - Percent of facilitators who respond on the survey that the intervention was acceptable or completely acceptable to them</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean pressure to eat score (Child Feeding Questionnaire)</measure>
      <time_frame>Month 4</time_frame>
      <description>The 4-item subscale from the Child Feeding Questionnaire, called Pressure to Eat, measures parents' tendency to pressure their children to eat more food, typically at mealtimes. Possible scores range from 1-5, with higher scores indicating greater severity of parents' tendency to pressuring their children to eat more food. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean restriction score (Child Feeding Questionnaire)</measure>
      <time_frame>Month 4</time_frame>
      <description>The 8-item subscale from the Child Feeding Questionnaire, called Restriction, measures the extent to which parents restrict their child's access to foods. Possible scores range from 1-5, with higher scores indicating greater severity of parents restricting their child's access to foods. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean satiety responsiveness score</measure>
      <time_frame>Month 4</time_frame>
      <description>Mean satiety responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores indicating higher self-regulation. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean food responsiveness score</measure>
      <time_frame>Month 4</time_frame>
      <description>Mean food responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean enjoyment of food score</measure>
      <time_frame>Month 4</time_frame>
      <description>Mean enjoyment of food score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean of families using structured mealtime practices</measure>
      <time_frame>Month 4</time_frame>
      <description>The 10-item Structure of Family Meals subscale from the Meals in our Household Questionnaire measures how often families spend their mealtimes in a specific setting. Possible scores range from 0-4, with higher scores indicating higher occurrences of specific mealtime settings. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of families eating family meals at least 3 times per week</measure>
      <time_frame>Month 4</time_frame>
      <description>Percentage of families eating family meals at least 3 times per week using Family Meal Frequency Questionnaire which asks how many times a week the family eats dinner together, both at home and at a restaurant. Information to be utilized in a future larger study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fidelity of intervention delivery - Percentage of key points</measure>
      <time_frame>month 4</time_frame>
      <description>Study staff will complete Evaluation Checklist of key points communicated during each session to determine intervention delivery - Percentage of key points communicated during the sessions from the Evaluation Checklist</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Facilitator Self-Competence Percentage - Percentage of facilitators</measure>
      <time_frame>month 4</time_frame>
      <description>Facilitator self-competence percentage will be collected from facilitators responding to an open-ended question after each session to evaluate the strong and weak points of their own delivery - : Percentage of facilitators who respond agree or strongly agree to survey question about perceived self-competence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fidelity of Receipt - : Percentage of parents</measure>
      <time_frame>month 4</time_frame>
      <description>Percentage of parents who respond agree or strongly agree to survey question about whether the video content was relevant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Parents who Identified a Goal</measure>
      <time_frame>month 4</time_frame>
      <description>Receipt will be collected through the follow-up survey. Information collected includes a response of &quot;yes&quot; or &quot;no&quot; by parent expert assessment of whether the parent identified an attainable, specific, and measurable goal. Percentage of parents who identified a goal will include the percentage who answer &quot;yes&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Enactment percentage</measure>
      <time_frame>month 4</time_frame>
      <description>Enactment will be collected through the follow-up survey. Enactment Percentage will include those considered by an expert to have made a specific and measurable change in feeding practices.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Qualitative Analysis</measure>
      <time_frame>month 4</time_frame>
      <description>Information collected from semi-structured interviews. Thematic analysis performed and coded by two independent investigators. Representative quotes will be recorded, and transcript codes will be grouped into similar categories. Investigators will interpret themes and sub-themes from these categories.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Obesity, Childhood</condition>
    <arm_group>
      <arm_group_label>Handout Only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Parents in this group receive an educational handout at the baseline visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online-Only Video Series</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group Sessions</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Parents will participate in 2 weekly group sessions with video viewing and group discussion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational Handout</intervention_name>
      <description>Educational handout describing responsive feeding practices.</description>
      <arm_group_label>Handout Only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Video Series</intervention_name>
      <description>Videos geared toward responsive feeding practices.</description>
      <arm_group_label>Group Sessions</arm_group_label>
      <arm_group_label>Online-Only Video Series</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Group Discussion Sessions</intervention_name>
      <description>Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.</description>
      <arm_group_label>Group Sessions</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Parent of 2-4 year old child&#xD;
  &#xD;
            -  Is at least 18 years old&#xD;
  &#xD;
            -  Participant can read and write English&#xD;
  &#xD;
            -  The participant's child has no medical conditions that affect development, feeding, or&#xD;
               growth&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant is not a parent of a 2-4 year old child&#xD;
  &#xD;
            -  Parent is less than 18 years old&#xD;
  &#xD;
            -  Parent can not read and write English&#xD;
  &#xD;
            -  Participant's child has a medical condition that affects development, feeding, or&#xD;
               growth&#xD;
  &#xD;
            -  Family/household member participating in study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Callie Brown, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Callie Brown, MD, MPH</last_name>
      <phone>336-716-4987</phone>
      <email>calbrown@wakehealth.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Atrium Health Wake Forest Baptist</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Callie Brown, MD, MPH</last_name>
        <phone>336-716-4987</phone>
        <email>calbrown@wakehealth.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>obesity</keyword>
    <keyword>young children</keyword>
    <keyword>feeding practices</keyword>
    <keyword>obesity prevention</keyword>
    <keyword>obesity intervention</keyword>
    <keyword>child feeding questionnaire</keyword>
    <keyword>satiety responsiveness</keyword>
    <keyword>food responsiveness</keyword>
    <keyword>family meal frequency questionnaire</keyword>
    <keyword>structure of family meals</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994924
  org study id: IRB00078071
  nct id: NCT05994924
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this qualitative trial study is to assess the usefulness and acceptability of the
        intervention in diverse clinical and community settings. The main questions it aims to answer
        are:
  
          -  How many parents were approached and consented to participate?
  
          -  How many parents viewed the videos via link versus viewed the video with a discussion in
             group sessions?
  
          -  How did parents feel about the process of being recruited and interventions that they
             participated in?
  
          -  How did the providers feel about the intervention recruitment and delivery?
  
          -  How did the facilitators feel about their delivery of the material? Participants will
             complete a survey and an interview after completing second part of the intervention.
  
        Researchers will compare handout, online-only video, and group class interventions to see if
        an intervention delivery is useful and accepted by parents or providers.
  This is a pilot randomized trial to assess feasibility and acceptability of STORY. The study
        will recruit 30 parents. Parents will complete a questionnaire and dyad's heights and weights
        will be measured. Families will be randomized to the control group or 1 of 2 intervention
        delivery approaches (IA). Parents will be given a handout (controls), links to the videos to
        watch independently (IA 1), or information on how they will be contacted to schedule their
        intervention sessions (IAs 2). After 2 video/sessions, all parents will complete a written
        survey assessing their experience with the intervention and any change same at home; the
        written survey will reassess baseline measures. Intervention parents will also complete a
        semi-structured interview to assess the family's experience with the STORY trial.
  
        Sub aim 2a: Feasibility: number of parents approached, number of parents consented Sub aim
        2b: Adherence: number of parents who complete videos or sessions Sub aim 2c: Acceptability to
        parents and providers
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of Parents Approached
  time frame: Baseline
  description: Number of parents who are approached for participation at 3 primary care offices.
  measure: Number of Parents Consented
  time frame: Baseline
  description: Number of parents that consented to participating in the study.
  measure: Number of Parents who Viewed Videos Provided by Provider
  time frame: Month 2
  description: tracking the number of videos viewed by each parent
  measure: Number of Parents who Complete In-Person Group Sessions
  time frame: Month 2
  description: tracking the number of sessions attended by each parent
  measure: Parent Acceptance of Intervention - Percent of parents
  time frame: Month 4
  description: Measure parent acceptability of intervention using brief survey and semi-structured interview responses - Percent of parents who respond on the survey that the intervention was acceptable or completely acceptable to them
  measure: Provider Acceptance of Intervention - Percent of providers
  time frame: Month 4
  description: Measure provider acceptability using a short survey - Percent of providers who respond on the survey that the intervention was acceptable or completely acceptable to them
  measure: Facilitator Acceptance of Intervention - Percent of facilitators
  time frame: Month 4
  description: Measure facilitator acceptability using semi-structured interviews - Percent of facilitators who respond on the survey that the intervention was acceptable or completely acceptable to them
  measure: Mean pressure to eat score (Child Feeding Questionnaire)
  time frame: Month 4
  description: The 4-item subscale from the Child Feeding Questionnaire, called Pressure to Eat, measures parents' tendency to pressure their children to eat more food, typically at mealtimes. Possible scores range from 1-5, with higher scores indicating greater severity of parents' tendency to pressuring their children to eat more food. Information to be utilized in a future larger study.
  measure: Mean restriction score (Child Feeding Questionnaire)
  time frame: Month 4
  description: The 8-item subscale from the Child Feeding Questionnaire, called Restriction, measures the extent to which parents restrict their child's access to foods. Possible scores range from 1-5, with higher scores indicating greater severity of parents restricting their child's access to foods. Information to be utilized in a future larger study.
  measure: Mean satiety responsiveness score
  time frame: Month 4
  description: Mean satiety responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores indicating higher self-regulation. Information to be utilized in a future larger study.
  measure: Mean food responsiveness score
  time frame: Month 4
  description: Mean food responsiveness score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study.
  measure: Mean enjoyment of food score
  time frame: Month 4
  description: Mean enjoyment of food score obtained using a 5-point scale from Child Eating Behavior Questionnaire. Possible scores range from 1-5, with higher scores on food responsiveness indicating lower self-regulation. Information to be utilized in a future larger study.
  measure: Mean of families using structured mealtime practices
  time frame: Month 4
  description: The 10-item Structure of Family Meals subscale from the Meals in our Household Questionnaire measures how often families spend their mealtimes in a specific setting. Possible scores range from 0-4, with higher scores indicating higher occurrences of specific mealtime settings. Information to be utilized in a future larger study.
  measure: Percentage of families eating family meals at least 3 times per week
  time frame: Month 4
  description: Percentage of families eating family meals at least 3 times per week using Family Meal Frequency Questionnaire which asks how many times a week the family eats dinner together, both at home and at a restaurant. Information to be utilized in a future larger study.
  measure: Fidelity of intervention delivery - Percentage of key points
  time frame: month 4
  description: Study staff will complete Evaluation Checklist of key points communicated during each session to determine intervention delivery - Percentage of key points communicated during the sessions from the Evaluation Checklist
  measure: Facilitator Self-Competence Percentage - Percentage of facilitators
  time frame: month 4
  description: Facilitator self-competence percentage will be collected from facilitators responding to an open-ended question after each session to evaluate the strong and weak points of their own delivery - : Percentage of facilitators who respond agree or strongly agree to survey question about perceived self-competence
  measure: Fidelity of Receipt - : Percentage of parents
  time frame: month 4
  description: Percentage of parents who respond agree or strongly agree to survey question about whether the video content was relevant
  measure: Percentage of Parents who Identified a Goal
  time frame: month 4
  description: Receipt will be collected through the follow-up survey. Information collected includes a response of "yes" or "no" by parent expert assessment of whether the parent identified an attainable, specific, and measurable goal. Percentage of parents who identified a goal will include the percentage who answer "yes".
  measure: Enactment percentage
  time frame: month 4
  description: Enactment will be collected through the follow-up survey. Enactment Percentage will include those considered by an expert to have made a specific and measurable change in feeding practices.
  measure: Qualitative Analysis
  time frame: month 4
  description: Information collected from semi-structured interviews. Thematic analysis performed and coded by two independent investigators. Representative quotes will be recorded, and transcript codes will be grouped into similar categories. Investigators will interpret themes and sub-themes from these categories.
  arm group label: Handout Only
  arm group type: Active Comparator
  description: Parents in this group receive an educational handout at the baseline visit.
  arm group label: Online-Only Video Series
  arm group type: Active Comparator
  description: Parents will be given (QR) quick-response codes to watch the videos on their own time with no discussion afterward.
  arm group label: Group Sessions
  arm group type: Active Comparator
  description: Parents will participate in 2 weekly group sessions with video viewing and group discussion.
  intervention type: Behavioral
  intervention name: Educational Handout
  description: Educational handout describing responsive feeding practices.
  arm group label: Handout Only
  intervention type: Behavioral
  intervention name: Video Series
  description: Videos geared toward responsive feeding practices.
  arm group label: Group Sessions
  arm group label: Online-Only Video Series
  intervention type: Behavioral
  intervention name: Group Discussion Sessions
  description: Group discussion following video viewing led by Imprints Cares, a community organization focused on early childhood education.
  arm group label: Group Sessions
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Callie Brown, MD, MPH
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Callie Brown, MD, MPH
  phone: 336-716-4987
  email: calbrown@wakehealth.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Obesity
  mesh term: Pediatric Obesity
  sharing ipd: No