<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/NCT03817021</url>
  </required_header>
  <id_info>
    <org_study_id>1R01DK120754-01</org_study_id>
    <nct_id>NCT03817021</nct_id>
  </id_info>
  <brief_title>ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth</brief_title>
  <acronym>ONE PATH</acronym>
  <official_title>ONE PATH: Optimizing Nutrition Education for Parents and Teachers for Healthy Growth</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>
      This proposal uses an innovative methodological framework, the multiphase optimization&#xD;
      strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention&#xD;
      that promotes child appetite self-regulation among a high-risk sample: families with&#xD;
      preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing&#xD;
      identification of the most efficacious intervention components (i.e., components that&#xD;
      contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will&#xD;
      intervene on ~760 families across 64 classrooms serving largely low-income, rural&#xD;
      populations. ONE PATH will capitalize on the existing infrastructure with the Supplemental&#xD;
      Nutrition Assistance Program Education to engage trusted Extension educators making this&#xD;
      model cost-effective, and increasing the potential for wide-scale dissemination and&#xD;
      sustainability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth&#xD;
      study will rigorously test the efficacy of adding responsive feeding (RF) and appetite&#xD;
      regulation components to an existing evidence-based intervention, the Nutrition and Physical&#xD;
      Activity Self-Assessment of Child Care (NAP SACC) program. NAP SACC intervenes on the&#xD;
      childcare setting environment and has been shown to lower child body mass index (BMI) in&#xD;
      childcare settings and positively impact food environment policies. NAP SACC lacks Responsive&#xD;
      Feeding (RF) guidance and does not target parents or the home environment, which is the focus&#xD;
      of this study. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood&#xD;
      Education providers (ECE), 2) preschool children, and 3) parents of the pre-school children,&#xD;
      to address childhood obesity in rural, under-served areas. ECE providers will receive&#xD;
      much-needed online RF training and coaching. Preschool children will receive an experiential&#xD;
      play-based curriculum delivered in the classroom focused on recognition of hunger and&#xD;
      fullness cues and using attention control and mindfulness strategies to regulate food intake.&#xD;
      Parents will receive RF and parenting guidance from ONE PATH educators through remote&#xD;
      coaching.&#xD;
&#xD;
      Aim 1 is to identify which intervention components improve feeding practices and children's&#xD;
      appetite regulation (primary), and BMI z-scores (secondary) over the 9-month school year. The&#xD;
      3 candidate intervention components include 1) RF interactive web-based training curriculum&#xD;
      and coaching for ECE providers (&quot;ECE provider intervention&quot;), 2) classroom curriculum that&#xD;
      teaches regulation strategies to preschool children (&quot;child intervention&quot;), and 3) responsive&#xD;
      parenting (RP) curriculum and interactive activities for parents that provide opportunities&#xD;
      to practice RF at home (&quot;parent intervention&quot;). The investigators will use the highly&#xD;
      efficient multi-phase optimization (MOST) experimental strategy powered to detect main&#xD;
      effects and all interactions.&#xD;
&#xD;
      Aim 2 is to improve understanding of the mechanisms by which the 3 candidate intervention&#xD;
      components work, and determine if individuals respond differently to intervention components&#xD;
      using the data from the experiment in Aim 1. The investigators will examine whether food&#xD;
      security and child temperament explain the effects of the intervention on the outcomes (child&#xD;
      appetite regulation, caregiver feeding practices, and child BMI z-score).&#xD;
&#xD;
      To investigate whether certain intervention components are more or less effective in certain&#xD;
      subgroups, the investigators will explore moderation by child sex, race/ethnicity, and BMI&#xD;
      categories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 21, 2022</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Using Multiphase Optimization (MOST) Strategy, we will examine 3 treatment factors and their interactions to determine a 'best' or optimum approach to education of the Early Childhood Environment (ECE), child and family.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Parents, educators and children will not be informed of their treatment factor status, but it will not be hidden from them either.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Child appetite self-regulation</measure>
    <time_frame>Post intervention (~9 months)</time_frame>
    <description>Difference in mean COMPX score at post-intervention between intervention and control conditions&#xD;
Child appetite self-regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On two occasions, children will be served a snack ~20 minutes prior to lunch - on one occasion, they will receive a low-calorie snack, and on the other a high-calorie snack (order will be randomized by classroom). Children will then be served an ad-libitum lunch (same foods on both occasions), and intake will be determined by pre- and post-weighing of food.&#xD;
The difference in intake between the two conditions reflects the child's ability to compensate for the higher calorie preload, a measure of appetite regulation. Caloric compensation score (COMPX) will be calculated as a percentage score. A COMPX of 100% reflects perfect caloric compensation. A COMPX higher than 100% indicates overcompensation, whereas a COMPX lower than 100% indicates under-compensation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent responsive feeding practices</measure>
    <time_frame>Baseline and post intervention (~9 months)</time_frame>
    <description>Differences in baseline-post change in parent feeding practice scores between intervention and control conditions&#xD;
Parent responsive feeding practices will be assessed using the Caregiver's Feeding Styles Questionnaire (CFSQ), a 19-item measure which classifies caregivers into 1 of 4 feeding styles (authoritarian, authoritative, indulgent and uninvolved). Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent responsive feeding practices</measure>
    <time_frame>Baseline and post intervention (~9 months)</time_frame>
    <description>Differences in baseline-post change in parent feeding practice scores between intervention and control conditions&#xD;
Parent responsive feeding practices will be assessed using the Structure and Control in Parent Feeding (SCPF) questionnaire, a 34-item measure that assesses positive, structure based feeding practices (i.e., limit-setting, consistent routines) and controlling feeding practices (i.e., restriction, pressure to eat). Items are scored on a 5-point likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early childhood educator (ECE) responsive feeding practices</measure>
    <time_frame>Post intervention (~9 months)</time_frame>
    <description>Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study.&#xD;
Early childhood educators responsive feeding practices will be assessed using the Mealtime Observation in Childcare Checklist (MOCC). This measure will capture whether educators engage in specific feeding styles and practices during meal time. Some of the behaviors observed will include: whether educators pressured children to eat their food, praised children for trying a certain food or finishing their food, or if they provided food- or non-food related rewards to children for eating food. Additionally, we will observe how educators handled food refusal and if they supported children's self-regulation. For each item on the check list, response options range from: 0 = No; 1 = Yes, sometimes (1-2 times), 3 = Yes, regularly (3+ times).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI z-scores</measure>
    <time_frame>Baseline and post intervention (~9 months)</time_frame>
    <description>Difference in change in BMI z-scores from baseline to post between intervention and control conditions&#xD;
Children's weights and heights will be obtained at baseline and the end of the study using standard procedures. BMI will be calculated and values will be standardized to z-scores and percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Appetite Regulation and Satiety Responsiveness</measure>
    <time_frame>Baseline and post intervention (~9 months)</time_frame>
    <description>Differences in change from baseline-post intervention in calories consumed in the Eating in the Absence of Hunger (EAH) task between intervention and control conditions.&#xD;
The EAH procedure measures children's snack food consumption when not hungry. Children will be presented with a variety of snack foods shortly after being fed a full meal. The snacks will be weighed prior to and following the procedure to calculate intake. This will be evaluated at baseline and post intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Appetite Regulation and Satiety Responsiveness</measure>
    <time_frame>Baseline and post intervention (~9 months)</time_frame>
    <description>Differences in change in appetitive traits (parent-rated) from baseline-post, and mean appetitive traits at post-intervention (ECE provider-rated) between intervention and control conditions.&#xD;
Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which will be completed by parents at baseline and post intervention and by ECE providers post intervention only. This measure assesses children's eating style using a 5-point scale (1 = never - 5 = always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Classroom/school food environment</measure>
    <time_frame>Post intervention (~9 months)</time_frame>
    <description>Differences in percent of classrooms exhibiting specified characteristics of food environment at post-intervention between intervention and control conditions.&#xD;
The ECE environment, including food and beverages served, physical environment, teacher engagement, and regulations, planned trainings &amp; formal education, and feeding practices will be assessed observationally at the conclusion of the project using the validated MOCC. We hope to observe more teacher engagement, positive environment and feeding practices, and visibility of more healthy foods in the classrooms post-intervention.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">768</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>All Factors On</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutrition and Physical Activity Self-Assessment of Childcare (Core NAP SACC) will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on/ECE on/Parent on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on/ECE on/Child on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on/ECE on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on/Parent on/Child on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on/Parent on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned off</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on/Child on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAP SACC on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned off</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CORE NAP SACC</intervention_name>
    <description>Modify the food environment following a self-assessment of current food conditions</description>
    <arm_group_label>All Factors On</arm_group_label>
    <arm_group_label>NAP SACC on</arm_group_label>
    <arm_group_label>NAP SACC on/Child on</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on/Child on</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on/Parent on</arm_group_label>
    <arm_group_label>NAP SACC on/Parent on</arm_group_label>
    <arm_group_label>NAP SACC on/Parent on/Child on</arm_group_label>
    <other_name>NAP SACC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ECE Provider</intervention_name>
    <description>Provide online training for Head Start educators</description>
    <arm_group_label>All Factors On</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on/Child on</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on/Parent on</arm_group_label>
    <other_name>Responsive feeding for early childhood educators</other_name>
    <other_name>ECE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Intervention</intervention_name>
    <description>Coach parents remotely to educate them on responsive feeding and parenting</description>
    <arm_group_label>All Factors On</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on/Parent on</arm_group_label>
    <arm_group_label>NAP SACC on/Parent on</arm_group_label>
    <arm_group_label>NAP SACC on/Parent on/Child on</arm_group_label>
    <other_name>RF</other_name>
    <other_name>Parent Responsive Feeding</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Child intervention</intervention_name>
    <description>Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices</description>
    <arm_group_label>All Factors On</arm_group_label>
    <arm_group_label>NAP SACC on/Child on</arm_group_label>
    <arm_group_label>NAP SACC on/ECE on/Child on</arm_group_label>
    <arm_group_label>NAP SACC on/Parent on/Child on</arm_group_label>
    <other_name>Appetite regulation</other_name>
    <other_name>Child regulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children must be enrolled in a participating Head Start center&#xD;
&#xD;
          -  children must be between 2 and 6 years old&#xD;
&#xD;
          -  parent or primary caregiver must be 18 years or older&#xD;
&#xD;
          -  parent/child English speaking&#xD;
&#xD;
          -  ECE providers must be employed in participating Head Start center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents will not be eligible to participate if their child is not eligible and/or not&#xD;
             enrolled in the study&#xD;
&#xD;
          -  ECE providers will not be eligible if they do not teach in a participating preschool&#xD;
             classroom&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer S Williams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer S Williams, PhD</last_name>
    <phone>814-865-0514</phone>
    <email>jfs195@psu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lindsey B Hess, MPH</last_name>
    <phone>814-865-2457</phone>
    <email>lbb135@psu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Pennsylvania State University</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Williams, PhD</last_name>
      <phone>814-865-5014</phone>
      <email>jfs195@psu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Lindsey Hess, MS</last_name>
      <phone>(814) 865-2457</phone>
      <email>lbb13@psu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>Jennifer Savage Williams</investigator_full_name>
    <investigator_title>Associate Professor of Nutritional Sciences</investigator_title>
  </responsible_party>
  <keyword>Responsive parenting</keyword>
  <keyword>Children's Appetite Self-Regulation</keyword>
  <keyword>Early Childhood Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified participant data will be available to researchers on request after the conclusion of the study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available one year following the conclusion of the study.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a request with planned use to the PI, and complete a data sharing agreement with Penn State University.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03817021
org study id: 1R01DK120754-01
nct id: NCT03817021
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposal uses an innovative methodological framework, the multiphase optimization
      strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention
      that promotes child appetite self-regulation among a high-risk sample: families with
      preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing
      identification of the most efficacious intervention components (i.e., components that
      contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will
      intervene on ~760 families across 64 classrooms serving largely low-income, rural
      populations. ONE PATH will capitalize on the existing infrastructure with the Supplemental
      Nutrition Assistance Program Education to engage trusted Extension educators making this
      model cost-effective, and increasing the potential for wide-scale dissemination and
      sustainability.
The ONE PATH: Optimizing Nutrition Education for Parents And Teachers for Healthy growth
      study will rigorously test the efficacy of adding responsive feeding (RF) and appetite
      regulation components to an existing evidence-based intervention, the Nutrition and Physical
      Activity Self-Assessment of Child Care (NAP SACC) program. NAP SACC intervenes on the
      childcare setting environment and has been shown to lower child body mass index (BMI) in
      childcare settings and positively impact food environment policies. NAP SACC lacks Responsive
      Feeding (RF) guidance and does not target parents or the home environment, which is the focus
      of this study. ONE PATH will intervene upon 3 unique targeted audiences, 1) Early Childhood
      Education providers (ECE), 2) preschool children, and 3) parents of the pre-school children,
      to address childhood obesity in rural, under-served areas. ECE providers will receive
      much-needed online RF training and coaching. Preschool children will receive an experiential
      play-based curriculum delivered in the classroom focused on recognition of hunger and
      fullness cues and using attention control and mindfulness strategies to regulate food intake.
      Parents will receive RF and parenting guidance from ONE PATH educators through remote
      coaching.

      Aim 1 is to identify which intervention components improve feeding practices and children's
      appetite regulation (primary), and BMI z-scores (secondary) over the 9-month school year. The
      3 candidate intervention components include 1) RF interactive web-based training curriculum
      and coaching for ECE providers ("ECE provider intervention"), 2) classroom curriculum that
      teaches regulation strategies to preschool children ("child intervention"), and 3) responsive
      parenting (RP) curriculum and interactive activities for parents that provide opportunities
      to practice RF at home ("parent intervention"). The investigators will use the highly
      efficient multi-phase optimization (MOST) experimental strategy powered to detect main
      effects and all interactions.

      Aim 2 is to improve understanding of the mechanisms by which the 3 candidate intervention
      components work, and determine if individuals respond differently to intervention components
      using the data from the experiment in Aim 1. The investigators will examine whether food
      security and child temperament explain the effects of the intervention on the outcomes (child
      appetite regulation, caregiver feeding practices, and child BMI z-score).

      To investigate whether certain intervention components are more or less effective in certain
      subgroups, the investigators will explore moderation by child sex, race/ethnicity, and BMI
      categories.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Using Multiphase Optimization (MOST) Strategy, we will examine 3 treatment factors and their interactions to determine a 'best' or optimum approach to education of the Early Childhood Environment (ECE), child and family.
primary purpose: Prevention
masking: None (Open Label)
masking description: Parents, educators and children will not be informed of their treatment factor status, but it will not be hidden from them either.
measure: Child appetite self-regulation
time frame: Post intervention (~9 months)
description: Difference in mean COMPX score at post-intervention between intervention and control conditions
Child appetite self-regulation skills will be assessed using the gold standard caloric compensation score (COMPX). On two occasions, children will be served a snack ~20 minutes prior to lunch - on one occasion, they will receive a low-calorie snack, and on the other a high-calorie snack (order will be randomized by classroom). Children will then be served an ad-libitum lunch (same foods on both occasions), and intake will be determined by pre- and post-weighing of food.
The difference in intake between the two conditions reflects the child's ability to compensate for the higher calorie preload, a measure of appetite regulation. Caloric compensation score (COMPX) will be calculated as a percentage score. A COMPX of 100% reflects perfect caloric compensation. A COMPX higher than 100% indicates overcompensation, whereas a COMPX lower than 100% indicates under-compensation.
measure: Parent responsive feeding practices
time frame: Baseline and post intervention (~9 months)
description: Differences in baseline-post change in parent feeding practice scores between intervention and control conditions
Parent responsive feeding practices will be assessed using the Caregiver's Feeding Styles Questionnaire (CFSQ), a 19-item measure which classifies caregivers into 1 of 4 feeding styles (authoritarian, authoritative, indulgent and uninvolved). Items are scored on a 5-point scale (1=never-5=always), with higher scores indicating higher frequency of engagement in a specific feeding style.
measure: Parent responsive feeding practices
time frame: Baseline and post intervention (~9 months)
description: Differences in baseline-post change in parent feeding practice scores between intervention and control conditions
Parent responsive feeding practices will be assessed using the Structure and Control in Parent Feeding (SCPF) questionnaire, a 34-item measure that assesses positive, structure based feeding practices (i.e., limit-setting, consistent routines) and controlling feeding practices (i.e., restriction, pressure to eat). Items are scored on a 5-point likert scale (0 = never- 4 = always), with higher scores indicating higher frequency of engagement in a specific feeding behavior.
measure: Early childhood educator (ECE) responsive feeding practices
time frame: Post intervention (~9 months)
description: Difference in percentage of educators engaging in specific feeding practices between intervention and control conditions at post-study.
Early childhood educators responsive feeding practices will be assessed using the Mealtime Observation in Childcare Checklist (MOCC). This measure will capture whether educators engage in specific feeding styles and practices during meal time. Some of the behaviors observed will include: whether educators pressured children to eat their food, praised children for trying a certain food or finishing their food, or if they provided food- or non-food related rewards to children for eating food. Additionally, we will observe how educators handled food refusal and if they supported children's self-regulation. For each item on the check list, response options range from: 0 = No; 1 = Yes, sometimes (1-2 times), 3 = Yes, regularly (3+ times).
measure: BMI z-scores
time frame: Baseline and post intervention (~9 months)
description: Difference in change in BMI z-scores from baseline to post between intervention and control conditions
Children's weights and heights will be obtained at baseline and the end of the study using standard procedures. BMI will be calculated and values will be standardized to z-scores and percentiles according to Centers for Disease Control (CDC) standards and adjusted for child's sex and age.
measure: Child Appetite Regulation and Satiety Responsiveness
time frame: Baseline and post intervention (~9 months)
description: Differences in change from baseline-post intervention in calories consumed in the Eating in the Absence of Hunger (EAH) task between intervention and control conditions.
The EAH procedure measures children's snack food consumption when not hungry. Children will be presented with a variety of snack foods shortly after being fed a full meal. The snacks will be weighed prior to and following the procedure to calculate intake. This will be evaluated at baseline and post intervention.
measure: Child Appetite Regulation and Satiety Responsiveness
time frame: Baseline and post intervention (~9 months)
description: Differences in change in appetitive traits (parent-rated) from baseline-post, and mean appetitive traits at post-intervention (ECE provider-rated) between intervention and control conditions.
Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which will be completed by parents at baseline and post intervention and by ECE providers post intervention only. This measure assesses children's eating style using a 5-point scale (1 = never - 5 = always).
measure: Classroom/school food environment
time frame: Post intervention (~9 months)
description: Differences in percent of classrooms exhibiting specified characteristics of food environment at post-intervention between intervention and control conditions.
The ECE environment, including food and beverages served, physical environment, teacher engagement, and regulations, planned trainings & formal education, and feeding practices will be assessed observationally at the conclusion of the project using the validated MOCC. We hope to observe more teacher engagement, positive environment and feeding practices, and visibility of more healthy foods in the classrooms post-intervention.
arm group label: All Factors On
arm group type: Experimental
description: Nutrition and Physical Activity Self-Assessment of Childcare (Core NAP SACC) will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned on
arm group label: NAP SACC on/ECE on/Parent on
arm group type: Experimental
description: Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned on Child intervention will be turned off
arm group label: NAP SACC on/ECE on/Child on
arm group type: Experimental
description: Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned on
arm group label: NAP SACC on/ECE on
arm group type: Experimental
description: Core NAP SACC will be turned on ECE Provider intervention will be turned on Parent intervention will be turned off Child intervention will be turned off
arm group label: NAP SACC on/Parent on/Child on
arm group type: Experimental
description: Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned on
arm group label: NAP SACC on/Parent on
arm group type: Experimental
description: Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned on Child intervention turned off
arm group label: NAP SACC on/Child on
arm group type: Experimental
description: Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned on
arm group label: NAP SACC on
arm group type: Experimental
description: Core NAP SACC turned on ECE Provider intervention turned off Parent intervention turned off Child intervention turned off
intervention type: Behavioral
intervention name: CORE NAP SACC
description: Modify the food environment following a self-assessment of current food conditions
arm group label: All Factors On
arm group label: NAP SACC on
arm group label: NAP SACC on/Child on
arm group label: NAP SACC on/ECE on
arm group label: NAP SACC on/ECE on/Child on
arm group label: NAP SACC on/ECE on/Parent on
arm group label: NAP SACC on/Parent on
arm group label: NAP SACC on/Parent on/Child on
other name: NAP SACC
intervention type: Behavioral
intervention name: ECE Provider
description: Provide online training for Head Start educators
arm group label: All Factors On
arm group label: NAP SACC on/ECE on
arm group label: NAP SACC on/ECE on/Child on
arm group label: NAP SACC on/ECE on/Parent on
other name: Responsive feeding for early childhood educators
other name: ECE
intervention type: Behavioral
intervention name: Parent Intervention
description: Coach parents remotely to educate them on responsive feeding and parenting
arm group label: All Factors On
arm group label: NAP SACC on/ECE on/Parent on
arm group label: NAP SACC on/Parent on
arm group label: NAP SACC on/Parent on/Child on
other name: RF
other name: Parent Responsive Feeding
intervention type: Behavioral
intervention name: Child intervention
description: Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
arm group label: All Factors On
arm group label: NAP SACC on/Child on
arm group label: NAP SACC on/ECE on/Child on
arm group label: NAP SACC on/Parent on/Child on
other name: Appetite regulation
other name: Child regulation
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer S Williams, PhD
role: Principal Investigator
affiliation: Penn State University
last name: Jennifer S Williams, PhD
phone: 814-865-0514
email: jfs195@psu.edu
last name: Lindsey B Hess, MPH
phone: 814-865-2457
email: lbb135@psu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: Jennifer Savage Williams
investigator title: Associate Professor of Nutritional Sciences
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: Deidentified participant data will be available to researchers on request after the conclusion of the study.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available one year following the conclusion of the study.
ipd access criteria: Researchers must submit a request with planned use to the PI, and complete a data sharing agreement with Penn State University.