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Increasing Food Literacy in Preschoolers to Reduce Obesity Risk

Primary Purpose

Food Preferences, Food Selection, Eating, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Eating Curriculum
Improving the Classroom Food and Mealtime Environment
Parent Education
ECE Food Acceptance Training
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Food Preferences focused on measuring Food literacy, Healthy growth, Child Development, Food Acceptance

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Preschool children enrolled in participating centers Exclusion Criteria: Severe food allergies that prevent children from consuming project foods Presence of a developmental or sensory disability that affects food intake and/or learning Lack of English fluency (children and caregivers) Children not regularly present during days/times that intervention lessons are delivered Parents who are not involved in feeding/preparing meals for children at least 50% of the time

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Healthy Bodies Project Comparison (HBP)

    Healthy Bodies Project Plus (HBP+)

    Arm 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).

    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.

    Outcomes

    Primary Outcome Measures

    Children's Food Acceptance
    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.
    Children's willingness to try novel foods
    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.
    Children's Food Literacy
    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.
    Children's Food Knowledge
    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.
    Children's Food Choices
    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).

    Secondary Outcome Measures

    Child Weight Status/Adiposity
    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.

    Full Information

    First Posted
    July 18, 2023
    Last Updated
    July 28, 2023
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05977348
    Brief Title
    Increasing Food Literacy in Preschoolers to Reduce Obesity Risk
    Official Title
    Increasing Food Literacy as a Means of Increasing Preschool Children's Food Acceptance and Reducing Obesity Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    August 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Penn State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Food Preferences, Food Selection, Eating, Healthy, Obesity, Childhood
    Keywords
    Food literacy, Healthy growth, Child Development, Food Acceptance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The project is a cluster-randomized trial, with a 1:1 ratio of classroom random assignment to intervention or control.
    Masking
    Outcomes Assessor
    Masking Description
    Study team members who will conduct individual research assessments with each child will be blinded to study condition.
    Allocation
    Randomized
    Enrollment
    770 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Bodies Project Comparison (HBP)
    Arm Type
    No Intervention
    Arm 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 Title
    Healthy Bodies Project Plus (HBP+)
    Arm Type
    Experimental
    Arm 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(s)
    Healthy Eating Curriculum
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Improving the Classroom Food and Mealtime Environment
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Parent Education
    Intervention 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ECE Food Acceptance Training
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Children's Food Acceptance
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Children's willingness to try novel foods
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Children's Food Literacy
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Children's Food Knowledge
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Children's Food Choices
    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).
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Secondary Outcome Measure Information:
    Title
    Child Weight Status/Adiposity
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Other Pre-specified Outcome Measures:
    Title
    Child food requests (parent report)
    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).
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Children's Appetitive Traits and Behaviors (parent and teacher report)
    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.
    Time Frame
    Baseline
    Title
    Children's Food Exposure (parent and teacher report)
    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.
    Time Frame
    Baseline
    Title
    Children's Mealtime Behaviors
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Food parenting practices (parent-report)
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Parent Nutrition Knowledge
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Household Food Security (parent-report)
    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.
    Time Frame
    Baseline
    Title
    Household Demographics and Parents' General Health (parent-report)
    Description
    Sociodemographic information, parent height and weight (lab-created questionnaire).
    Time Frame
    Baseline
    Title
    Childcare Provider Nutrition Knowledge
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Childcare Provider Feeding Beliefs
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Childcare Provider Demographics
    Description
    Sociodemographic information, teaching experience, height, weight, physical activity frequency (lab-created questionnaire).
    Time Frame
    Baseline
    Title
    Classroom Food and Mealtime Environment
    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.
    Time Frame
    Change from baseline to post-intervention (~6 months)
    Title
    Classroom Chaos
    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.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Preschool children enrolled in participating centers Exclusion Criteria: Severe food allergies that prevent children from consuming project foods Presence of a developmental or sensory disability that affects food intake and/or learning Lack of English fluency (children and caregivers) Children not regularly present during days/times that intervention lessons are delivered Parents who are not involved in feeding/preparing meals for children at least 50% of the time
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lori A Francis, Ph.D.
    Phone
    814-863-0213
    Email
    lfrancis@psu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Regina H Lozinski, M.S.
    Phone
    814-865-0045
    Email
    rmh215@psu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lori A Francis, Ph.D.
    Organizational Affiliation
    Penn State University; Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be shared after all primary and secondary analyses are completed to address study aims.
    IPD Sharing Time Frame
    Data will be made available in perpetuity after all primary and secondary analyses are completed to address study aims.
    IPD Sharing Access Criteria
    The data can be accessed by contacting the principal investigator after the specified time period.

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    Increasing Food Literacy in Preschoolers to Reduce Obesity Risk

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