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/NCT05977348</url>
    </required_header>
    <id_info>
      <org_study_id>OSP#233045</org_study_id>
      <secondary_id>2023-68015-39416</secondary_id>
      <nct_id>NCT05977348</nct_id>
    </id_info>
    <brief_title>Increasing Food Literacy in Preschoolers to Reduce Obesity Risk</brief_title>
    <official_title>Increasing Food Literacy as a Means of Increasing Preschool Children's Food Acceptance and Reducing Obesity Risk</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Penn State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Penn State University</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 clinical trial is to examine the effects of a nutrition education program on&#xD;
        preschool children's food literacy and food acceptance, and to examine the added influence of&#xD;
        a healthy eating curriculum and parent education on children's food knowledge and healthful&#xD;
        food choices. The project will be evaluated with 450 children ages 3 to 5 years in&#xD;
        center-based childcare programs serving predominantly Supplemental Nutrition Assistance&#xD;
        Program (SNAP)-eligible families in Pennsylvania. Outcomes for children who receive the added&#xD;
        healthy eating curriculum will be compared to children in classrooms that only receive the&#xD;
        nutrition education program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Repeatedly exposing young children to new foods can increase their willingness to try those&#xD;
        foods, and they may - with time - learn to like those foods. Being able to learn about, touch&#xD;
        and taste new foods can be a powerful tool to foster young children's liking of new foods.&#xD;
        This project's goals are to test whether a preschool nutrition education program can improve&#xD;
        (1) children's ability to name and identify fruits and vegetables, (2) children's knowledge&#xD;
        about food and nutrition, (3) children's healthful food choices during a meal, and (4)&#xD;
        parenting around children's eating. Participants will include 450 children ages 3 to 5 years&#xD;
        in center-based childcare programs serving a large majority of families experiencing poverty&#xD;
        in Pennsylvania. In all classrooms, children will receive food literacy lessons designed to&#xD;
        help them learn about different fruits and vegetables, where they grow, and why they are good&#xD;
        for our bodies. Children in intervention classrooms will receive food literacy lessons, in&#xD;
        addition to lessons on healthy eating designed to improve children's nutrition knowledge.&#xD;
        Teachers in intervention classrooms will be provided with materials designed to increase&#xD;
        children's knowledge about nutrition and healthy eating. Intervention parents will receive&#xD;
        web-based lessons designed to improve parenting practices related to children's eating&#xD;
        behaviors. The study will be conducted over a 14-month period, and a variety of child,&#xD;
        teacher, classroom and parent outcomes will be measured before, during and after the&#xD;
        intervention. The results of this study are anticipated to add new information on ways to&#xD;
        improve children's nutrition knowledge and acceptance of fruits and vegetables.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</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>
      <intervention_model_description>The project is a cluster-randomized trial, with a 1:1 ratio of classroom random assignment to intervention or control.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Study team members who will conduct individual research assessments with each child will be blinded to study condition.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Children's Food Acceptance</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Teachers reports of each child's willingness to try and liking of weekly target foods; lab-created measure. Scores for trying (yes/no) and liking (yes/no) are summed to create total scores for each. Scores range from 0 to 26 for trying and liking. Higher scores indicate a higher frequency of trying weekly foods and higher frequency of liking seeking foods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Children's willingness to try novel foods</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Observed measure of children's willingness to try 4 novel foods (The Tasting Game; lab-created measure). The child scores 1 point for each bite of food that is tasted or eaten. Scores for each range from 0 (none tasted/eaten) to 3 (all pieces tasted/eaten). Total scores range from 0 to 12, and are created by summing the points obtained for each food item. Higher scores indicate a greater willingness to try foods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Children's Food Literacy</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Observed measure of children's ability to name/identify 6 foods using pictures (Food Literacy Scale; lab-created measure). Children receive a score of 0 (incorrect/don't know), 1 (correctly identified on the second pass), or 2 (correctly named on the first pass) points. Total scores range from 0 to 12, and are created by summing the points obtained for each food item. Higher scores indicate higher food literacy or ability to identify foods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Children's Food Knowledge</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Observed measure of children's ability to differentiate between nutrient- and energy-dense foods using the Snack Selection Protocol (Sigma-Grant et al., 2014). Children receive 1 point for each nutrient-dense food item chosen. Scores range from 0-18, with higher scores indicating nutrient-dense foods being chosen more often energy-dense foods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Children's Food Choices</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Observed measure of children's food choices when given the option to choose a nutrient- vs. energy-dense snack (live-coded; lab-created measure). Children receive a score of either 0 (energy-dense food chosen) or 1 (nutrient-dense food chosen).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Child Weight Status/Adiposity</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Child age- and sex-specific Body Mass Indices (BMI) from measured height and weight. Conditional weight gain (rate of change in children's BMIz), will be calculated as the standardized residual of the linear regression of post-intervention BMIz predicted by baseline BMIz, adjusted for child age and sex.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Child food requests (parent report)</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Children's requests for foods used in the study, as well as general requests for fruits and vegetables (Fruit and Vegetable Survey; lab-created measure).</description>
    </other_outcome>
    <other_outcome>
      <measure>Children's Appetitive Traits and Behaviors (parent and teacher report)</measure>
      <time_frame>Baseline</time_frame>
      <description>Measure of food approach and avoidance behaviors (e.g., satiety responsiveness and food enjoyment) measured using the Children's Eating Behaviour Questionnaire (Wardle et al., 2001). Response options range from 1 to 5 and subscale scores are calculated by averaging the items within each subscale. Higher scores for any subscale indicate the respondent's perception of a greater degree of the particular eating style in the child.</description>
    </other_outcome>
    <other_outcome>
      <measure>Children's Food Exposure (parent and teacher report)</measure>
      <time_frame>Baseline</time_frame>
      <description>Measure of children's previous experience and familiarity with target foods using the Children's Food Exposure Questionnaire (lab-created). Scores are calculated by averaging the items within each subscale. Subscale 1 scores range from 0-8 points, subscales 2-6 scores range from 0-3. Higher scores for subscales indicate (1) higher availability of fruits and vegetables; (2) more encouragement to eat fruits and vegetables; (3) more modeling of fruit and vegetable consumption by mothers; (4) more asking for fruits and vegetables by children; (4) children have more barriers to eat fruits and vegetables; (6) and caregivers have more barriers to eat fruits and vegetables respectively.</description>
    </other_outcome>
    <other_outcome>
      <measure>Children's Mealtime Behaviors</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>A lab-created, parent-report measure of children's media use while eating. Response options on this 3-item measure range from 1 to 4. Scores are calculated by averaging the items, with higher scores indicate a higher frequency of the child eating while watching television.</description>
    </other_outcome>
    <other_outcome>
      <measure>Food parenting practices (parent-report)</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Measure of parents' food-related practices (e.g., coercive vs. responsive feeding practices) using the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman &amp; Holub, 2007). This instrument includes 12 sub scales with response options ranging from 1-5; items are averaged to create each sub scale. Higher scores indicate a greater degree or frequency of use of the food parenting strategy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Parent Nutrition Knowledge</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Parent/caregiver knowledge about topics such as appropriate portion sizes, number of snacks preschoolers need each day, etc. using an adapted version of a Nutrition Knowledge Questionnaire developed by Rapson et al. (2020). This adapted 53-item questionnaire includes forced-choice and open-ended questions. Respondents score 1 point for correct answers on all nutrition knowledge items and 0 points for an incorrect or &quot;choose not to answer&quot; response. Incorrect responses, or responses that are contradictory to nutrition guidelines are also scored as 0 points. A composite score is obtained by summing answers to all nutrition knowledge items. Higher scores indicate a higher levels of nutrition knowledge to support healthy eating/feeding practices for preschool aged children.</description>
    </other_outcome>
    <other_outcome>
      <measure>Household Food Security (parent-report)</measure>
      <time_frame>Baseline</time_frame>
      <description>Household, adult and child food insecurity and hunger measured using the 18-item U.S. Household Food Security Survey. If there is no missing data, respondents can be categorized based on their sum score across all 18 questions. Categories and their respective scores are as follows: (1) High Food Security: 0-2 points, (2) Marginal Food Security: 3-7 points, (3) Low Food Security: 8-12 points, and (4) Very Low Food Security: 13-18 points. Affirmative items (with responses) are summed to create a raw score, with scores ranging from 0-18 points. Higher scores indicate greater household food insecurity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Household Demographics and Parents' General Health (parent-report)</measure>
      <time_frame>Baseline</time_frame>
      <description>Sociodemographic information, parent height and weight (lab-created questionnaire).</description>
    </other_outcome>
    <other_outcome>
      <measure>Childcare Provider Nutrition Knowledge</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Childcare provider knowledge about topics such as appropriate portion sizes, number of snacks preschoolers need each day, etc. measured using an Early Childhood Educator Nutrition Knowledge Questionnaire developed by Rapson et al. (2020). This 57-item questionnaire includes forced-choice and open-ended questions. Respondents score 1 point for correct answers on all nutrition knowledge items and 0 points for an incorrect or &quot;choose not to answer&quot; response. Incorrect responses, or responses that are contradictory to nutrition guidelines are also scored as 0 points. A composite score is obtained by summing answers to all nutrition knowledge items. Higher scores indicate a higher levels of nutrition knowledge to support healthy eating/feeding practices for preschool aged children.</description>
    </other_outcome>
    <other_outcome>
      <measure>Childcare Provider Feeding Beliefs</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>Childcare provider mealtime behaviors and feeding practices measured using the About Feeding Children questionnaire (Swindle et al., 2018). This questionnaire contains 31 items and 9 subscales. Higher scores on each of the subscales indicate the degree to which the respondent utilizes the mealtime strategy or agrees with particular mealtime beliefs.</description>
    </other_outcome>
    <other_outcome>
      <measure>Childcare Provider Demographics</measure>
      <time_frame>Baseline</time_frame>
      <description>Sociodemographic information, teaching experience, height, weight, physical activity frequency (lab-created questionnaire).</description>
    </other_outcome>
    <other_outcome>
      <measure>Classroom Food and Mealtime Environment</measure>
      <time_frame>Change from baseline to post-intervention (~6 months)</time_frame>
      <description>An observational measure of the classroom food and mealtime environment. Response options range from 1 to 4, and scores are calculated by averaging the items within each subscale. Higher scores indicate (1) a higher degree of visuals that support healthy eating; and (2) teacher and child dynamics during mealtime that are consistent with healthy eating practices.</description>
    </other_outcome>
    <other_outcome>
      <measure>Classroom Chaos</measure>
      <time_frame>Baseline</time_frame>
      <description>An adapted measure of classroom chaos using the Confusion, Hubbub and Order Scale for classrooms (Wachs et al., 2004). Response options range from 1 to 4, and a total score is calculated by averaging scores for 12 items. Higher scores indicate more chaos, disorganization, and noise level in the classroom.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">770</enrollment>
    <condition>Food Preferences</condition>
    <condition>Food Selection</condition>
    <condition>Eating, Healthy</condition>
    <condition>Obesity, Childhood</condition>
    <arm_group>
      <arm_group_label>Healthy Bodies Project Comparison (HBP)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>All classrooms will receive the Eating the Alphabet curriculum, which includes 27 lessons that introduce children to a new fruit or vegetable from A-Z each week. Parents in comparison and intervention classrooms will receive access to web-based parent resources related to the Eating the Alphabet curriculum (e.g., food of the week fact sheets with recipes and suggestions for use, and coloring pages).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy Bodies Project Plus (HBP+)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention classrooms will receive the Eating the Alphabet curriculum described above for comparison classrooms, in addition to (1) the Healthy Eating curriculum, (2) classroom materials and teacher training designed to improve the classroom food and mealtime environment in ways that increase food acceptance, and (3) parent/caregiver education on responsive food parenting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Healthy Eating Curriculum</intervention_name>
      <description>The Healthy Eating (HE) curriculum is designed to provide children with skills needed to develop healthy eating habits. Each lesson builds upon the overall goal of creating a healthy restaurant. Children are taught to identify differences between GO and WHOA foods, recognize the five food groups, and learn to make healthy food choices.</description>
      <arm_group_label>Healthy Bodies Project Plus (HBP+)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Improving the Classroom Food and Mealtime Environment</intervention_name>
      <description>HBP+ Classrooms will receive additional sensory activities for each lesson (e.g., posters, food models, games) designed to improve the classroom food environment and provide repeated exposure to activities and messages about fruits and vegetables. Teachers in HBP+ classrooms will be provided with additional training on strategies shown to increase food acceptance in preschool children (e.g., modeling, encouraging children to try foods without coercion). In addition, HBP+ classrooms will include &quot;tasting charts&quot; that children will stamp to indicate their liking for each food each week.</description>
      <arm_group_label>Healthy Bodies Project Plus (HBP+)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent Education</intervention_name>
      <description>Parents in intervention classrooms will be given access to 8 web-based lessons on food parenting and responsive parenting. Topics include: establishing mealtime routines, shopping healthy on a budget; modeling of healthy eating behaviors; addressing picky eating in children; structuring low-stress mealtime environments; the division of responsibility in feeding, and portion control.</description>
      <arm_group_label>Healthy Bodies Project Plus (HBP+)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ECE Food Acceptance Training</intervention_name>
      <description>HBP+ early childhood educators (ECEs) will be asked to complete an online, self-paced course on increasing food acceptance in preschool children. Topics will include: repeated exposure to foods; modeling of healthy eating behaviors; addressing picky eating in children; structuring low-stress mealtime environments; and the division of responsibility in feeding.</description>
      <arm_group_label>Healthy Bodies Project Plus (HBP+)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Preschool children enrolled in participating centers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe food allergies that prevent children from consuming project foods&#xD;
  &#xD;
            -  Presence of a developmental or sensory disability that affects food intake and/or&#xD;
               learning&#xD;
  &#xD;
            -  Lack of English fluency (children and caregivers)&#xD;
  &#xD;
            -  Children not regularly present during days/times that intervention lessons are&#xD;
               delivered&#xD;
  &#xD;
            -  Parents who are not involved in feeding/preparing meals for children at least 50% of&#xD;
               the time&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lori A Francis, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Penn State University; Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lori A Francis, Ph.D.</last_name>
      <phone>814-863-0213</phone>
      <email>lfrancis@psu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Regina H Lozinski, M.S.</last_name>
      <phone>814-865-0045</phone>
      <email>rmh215@psu.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Penn State University</investigator_affiliation>
      <investigator_full_name>Lori Francis</investigator_full_name>
      <investigator_title>Professor of Biobehavioral Health</investigator_title>
    </responsible_party>
    <keyword>Food literacy</keyword>
    <keyword>Healthy growth</keyword>
    <keyword>Child Development</keyword>
    <keyword>Food Acceptance</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>Yes</sharing_ipd>
      <ipd_description>Data will be shared after all primary and secondary analyses are completed to address study aims.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be made available in perpetuity after all primary and secondary analyses are completed to address study aims.</ipd_time_frame>
      <ipd_access_criteria>The data can be accessed by contacting the principal investigator after the specified time period.</ipd_access_criteria>
    </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/NCT05977348
  org study id: OSP#233045
  secondary id: 2023-68015-39416
  nct id: NCT05977348
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to examine the effects of a nutrition education program on
        preschool children's food literacy and food acceptance, and to examine the added influence of
        a healthy eating curriculum and parent education on children's food knowledge and healthful
        food choices. The project will be evaluated with 450 children ages 3 to 5 years in
        center-based childcare programs serving predominantly Supplemental Nutrition Assistance
        Program (SNAP)-eligible families in Pennsylvania. Outcomes for children who receive the added
        healthy eating curriculum will be compared to children in classrooms that only receive the
        nutrition education program.
  Repeatedly exposing young children to new foods can increase their willingness to try those
        foods, and they may - with time - learn to like those foods. Being able to learn about, touch
        and taste new foods can be a powerful tool to foster young children's liking of new foods.
        This project's goals are to test whether a preschool nutrition education program can improve
        (1) children's ability to name and identify fruits and vegetables, (2) children's knowledge
        about food and nutrition, (3) children's healthful food choices during a meal, and (4)
        parenting around children's eating. Participants will include 450 children ages 3 to 5 years
        in center-based childcare programs serving a large majority of families experiencing poverty
        in Pennsylvania. In all classrooms, children will receive food literacy lessons designed to
        help them learn about different fruits and vegetables, where they grow, and why they are good
        for our bodies. Children in intervention classrooms will receive food literacy lessons, in
        addition to lessons on healthy eating designed to improve children's nutrition knowledge.
        Teachers in intervention classrooms will be provided with materials designed to increase
        children's knowledge about nutrition and healthy eating. Intervention parents will receive
        web-based lessons designed to improve parenting practices related to children's eating
        behaviors. The study will be conducted over a 14-month period, and a variety of child,
        teacher, classroom and parent outcomes will be measured before, during and after the
        intervention. The results of this study are anticipated to add new information on ways to
        improve children's nutrition knowledge and acceptance of fruits and vegetables.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The project is a cluster-randomized trial, with a 1:1 ratio of classroom random assignment to intervention or control.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: Study team members who will conduct individual research assessments with each child will be blinded to study condition.
  measure: Children's Food Acceptance
  time frame: Change from baseline to post-intervention (~6 months)
  description: Teachers reports of each child's willingness to try and liking of weekly target foods; lab-created measure. Scores for trying (yes/no) and liking (yes/no) are summed to create total scores for each. Scores range from 0 to 26 for trying and liking. Higher scores indicate a higher frequency of trying weekly foods and higher frequency of liking seeking foods.
  measure: Children's willingness to try novel foods
  time frame: Change from baseline to post-intervention (~6 months)
  description: Observed measure of children's willingness to try 4 novel foods (The Tasting Game; lab-created measure). The child scores 1 point for each bite of food that is tasted or eaten. Scores for each range from 0 (none tasted/eaten) to 3 (all pieces tasted/eaten). Total scores range from 0 to 12, and are created by summing the points obtained for each food item. Higher scores indicate a greater willingness to try foods.
  measure: Children's Food Literacy
  time frame: Change from baseline to post-intervention (~6 months)
  description: Observed measure of children's ability to name/identify 6 foods using pictures (Food Literacy Scale; lab-created measure). Children receive a score of 0 (incorrect/don't know), 1 (correctly identified on the second pass), or 2 (correctly named on the first pass) points. Total scores range from 0 to 12, and are created by summing the points obtained for each food item. Higher scores indicate higher food literacy or ability to identify foods.
  measure: Children's Food Knowledge
  time frame: Change from baseline to post-intervention (~6 months)
  description: Observed measure of children's ability to differentiate between nutrient- and energy-dense foods using the Snack Selection Protocol (Sigma-Grant et al., 2014). Children receive 1 point for each nutrient-dense food item chosen. Scores range from 0-18, with higher scores indicating nutrient-dense foods being chosen more often energy-dense foods.
  measure: Children's Food Choices
  time frame: Change from baseline to post-intervention (~6 months)
  description: Observed measure of children's food choices when given the option to choose a nutrient- vs. energy-dense snack (live-coded; lab-created measure). Children receive a score of either 0 (energy-dense food chosen) or 1 (nutrient-dense food chosen).
  measure: Child Weight Status/Adiposity
  time frame: Change from baseline to post-intervention (~6 months)
  description: Child age- and sex-specific Body Mass Indices (BMI) from measured height and weight. Conditional weight gain (rate of change in children's BMIz), will be calculated as the standardized residual of the linear regression of post-intervention BMIz predicted by baseline BMIz, adjusted for child age and sex.
  measure: Child food requests (parent report)
  time frame: Change from baseline to post-intervention (~6 months)
  description: Children's requests for foods used in the study, as well as general requests for fruits and vegetables (Fruit and Vegetable Survey; lab-created measure).
  measure: Children's Appetitive Traits and Behaviors (parent and teacher report)
  time frame: Baseline
  description: Measure of food approach and avoidance behaviors (e.g., satiety responsiveness and food enjoyment) measured using the Children's Eating Behaviour Questionnaire (Wardle et al., 2001). Response options range from 1 to 5 and subscale scores are calculated by averaging the items within each subscale. Higher scores for any subscale indicate the respondent's perception of a greater degree of the particular eating style in the child.
  measure: Children's Food Exposure (parent and teacher report)
  time frame: Baseline
  description: Measure of children's previous experience and familiarity with target foods using the Children's Food Exposure Questionnaire (lab-created). Scores are calculated by averaging the items within each subscale. Subscale 1 scores range from 0-8 points, subscales 2-6 scores range from 0-3. Higher scores for subscales indicate (1) higher availability of fruits and vegetables; (2) more encouragement to eat fruits and vegetables; (3) more modeling of fruit and vegetable consumption by mothers; (4) more asking for fruits and vegetables by children; (4) children have more barriers to eat fruits and vegetables; (6) and caregivers have more barriers to eat fruits and vegetables respectively.
  measure: Children's Mealtime Behaviors
  time frame: Change from baseline to post-intervention (~6 months)
  description: A lab-created, parent-report measure of children's media use while eating. Response options on this 3-item measure range from 1 to 4. Scores are calculated by averaging the items, with higher scores indicate a higher frequency of the child eating while watching television.
  measure: Food parenting practices (parent-report)
  time frame: Change from baseline to post-intervention (~6 months)
  description: Measure of parents' food-related practices (e.g., coercive vs. responsive feeding practices) using the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman & Holub, 2007). This instrument includes 12 sub scales with response options ranging from 1-5; items are averaged to create each sub scale. Higher scores indicate a greater degree or frequency of use of the food parenting strategy.
  measure: Parent Nutrition Knowledge
  time frame: Change from baseline to post-intervention (~6 months)
  description: Parent/caregiver knowledge about topics such as appropriate portion sizes, number of snacks preschoolers need each day, etc. using an adapted version of a Nutrition Knowledge Questionnaire developed by Rapson et al. (2020). This adapted 53-item questionnaire includes forced-choice and open-ended questions. Respondents score 1 point for correct answers on all nutrition knowledge items and 0 points for an incorrect or "choose not to answer" response. Incorrect responses, or responses that are contradictory to nutrition guidelines are also scored as 0 points. A composite score is obtained by summing answers to all nutrition knowledge items. Higher scores indicate a higher levels of nutrition knowledge to support healthy eating/feeding practices for preschool aged children.
  measure: Household Food Security (parent-report)
  time frame: Baseline
  description: Household, adult and child food insecurity and hunger measured using the 18-item U.S. Household Food Security Survey. If there is no missing data, respondents can be categorized based on their sum score across all 18 questions. Categories and their respective scores are as follows: (1) High Food Security: 0-2 points, (2) Marginal Food Security: 3-7 points, (3) Low Food Security: 8-12 points, and (4) Very Low Food Security: 13-18 points. Affirmative items (with responses) are summed to create a raw score, with scores ranging from 0-18 points. Higher scores indicate greater household food insecurity.
  measure: Household Demographics and Parents' General Health (parent-report)
  time frame: Baseline
  description: Sociodemographic information, parent height and weight (lab-created questionnaire).
  measure: Childcare Provider Nutrition Knowledge
  time frame: Change from baseline to post-intervention (~6 months)
  description: Childcare provider knowledge about topics such as appropriate portion sizes, number of snacks preschoolers need each day, etc. measured using an Early Childhood Educator Nutrition Knowledge Questionnaire developed by Rapson et al. (2020). This 57-item questionnaire includes forced-choice and open-ended questions. Respondents score 1 point for correct answers on all nutrition knowledge items and 0 points for an incorrect or "choose not to answer" response. Incorrect responses, or responses that are contradictory to nutrition guidelines are also scored as 0 points. A composite score is obtained by summing answers to all nutrition knowledge items. Higher scores indicate a higher levels of nutrition knowledge to support healthy eating/feeding practices for preschool aged children.
  measure: Childcare Provider Feeding Beliefs
  time frame: Change from baseline to post-intervention (~6 months)
  description: Childcare provider mealtime behaviors and feeding practices measured using the About Feeding Children questionnaire (Swindle et al., 2018). This questionnaire contains 31 items and 9 subscales. Higher scores on each of the subscales indicate the degree to which the respondent utilizes the mealtime strategy or agrees with particular mealtime beliefs.
  measure: Childcare Provider Demographics
  time frame: Baseline
  description: Sociodemographic information, teaching experience, height, weight, physical activity frequency (lab-created questionnaire).
  measure: Classroom Food and Mealtime Environment
  time frame: Change from baseline to post-intervention (~6 months)
  description: An observational measure of the classroom food and mealtime environment. Response options range from 1 to 4, and scores are calculated by averaging the items within each subscale. Higher scores indicate (1) a higher degree of visuals that support healthy eating; and (2) teacher and child dynamics during mealtime that are consistent with healthy eating practices.
  measure: Classroom Chaos
  time frame: Baseline
  description: An adapted measure of classroom chaos using the Confusion, Hubbub and Order Scale for classrooms (Wachs et al., 2004). Response options range from 1 to 4, and a total score is calculated by averaging scores for 12 items. Higher scores indicate more chaos, disorganization, and noise level in the classroom.
  arm group label: Healthy Bodies Project Comparison (HBP)
  arm group type: No Intervention
  description: All classrooms will receive the Eating the Alphabet curriculum, which includes 27 lessons that introduce children to a new fruit or vegetable from A-Z each week. Parents in comparison and intervention classrooms will receive access to web-based parent resources related to the Eating the Alphabet curriculum (e.g., food of the week fact sheets with recipes and suggestions for use, and coloring pages).
  arm group label: Healthy Bodies Project Plus (HBP+)
  arm group type: Experimental
  description: Intervention classrooms will receive the Eating the Alphabet curriculum described above for comparison classrooms, in addition to (1) the Healthy Eating curriculum, (2) classroom materials and teacher training designed to improve the classroom food and mealtime environment in ways that increase food acceptance, and (3) parent/caregiver education on responsive food parenting.
  intervention type: Behavioral
  intervention name: Healthy Eating Curriculum
  description: The Healthy Eating (HE) curriculum is designed to provide children with skills needed to develop healthy eating habits. Each lesson builds upon the overall goal of creating a healthy restaurant. Children are taught to identify differences between GO and WHOA foods, recognize the five food groups, and learn to make healthy food choices.
  arm group label: Healthy Bodies Project Plus (HBP+)
  intervention type: Behavioral
  intervention name: Improving the Classroom Food and Mealtime Environment
  description: HBP+ Classrooms will receive additional sensory activities for each lesson (e.g., posters, food models, games) designed to improve the classroom food environment and provide repeated exposure to activities and messages about fruits and vegetables. Teachers in HBP+ classrooms will be provided with additional training on strategies shown to increase food acceptance in preschool children (e.g., modeling, encouraging children to try foods without coercion). In addition, HBP+ classrooms will include "tasting charts" that children will stamp to indicate their liking for each food each week.
  arm group label: Healthy Bodies Project Plus (HBP+)
  intervention type: Behavioral
  intervention name: Parent Education
  description: Parents in intervention classrooms will be given access to 8 web-based lessons on food parenting and responsive parenting. Topics include: establishing mealtime routines, shopping healthy on a budget; modeling of healthy eating behaviors; addressing picky eating in children; structuring low-stress mealtime environments; the division of responsibility in feeding, and portion control.
  arm group label: Healthy Bodies Project Plus (HBP+)
  intervention type: Behavioral
  intervention name: ECE Food Acceptance Training
  description: HBP+ early childhood educators (ECEs) will be asked to complete an online, self-paced course on increasing food acceptance in preschool children. Topics will include: repeated exposure to foods; modeling of healthy eating behaviors; addressing picky eating in children; structuring low-stress mealtime environments; and the division of responsibility in feeding.
  arm group label: Healthy Bodies Project Plus (HBP+)
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lori A Francis, Ph.D.
  role: Principal Investigator
  affiliation: Penn State University; Professor
  last name: Lori A Francis, Ph.D.
  phone: 814-863-0213
  email: lfrancis@psu.edu
  last name: Regina H Lozinski, M.S.
  phone: 814-865-0045
  email: rmh215@psu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Penn State University
  investigator full name: Lori Francis
  investigator title: Professor of Biobehavioral Health
  mesh term: Obesity
  mesh term: Pediatric Obesity
  sharing ipd: Yes
  ipd description: Data will be shared after all primary and secondary analyses are completed to address study aims.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: Data will be made available in perpetuity after all primary and secondary analyses are completed to address study aims.
  ipd access criteria: The data can be accessed by contacting the principal investigator after the specified time period.