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Healthy Bodies Project to Prevent Childhood Obesity (Healthy Bodies)

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Eating, Active Play, Self-Regulation, Parent Education
Healthy Eating, Active Play, Self-Regulation
Healthy Eating, Active Play, Parent Education
Healthy Eating + Active Play
Healthy Eating, Self-Regulation, Parent Education
Healthy Eating + Self-Regulation
Healthy Eating + Parent Education
Healthy Eating Only
Active Play, Self-Regulation, Parent Education
Active Play + Self-Regulation
Active Play + Parent Education
Active Play Only
Self-Regulation + Parent Education
Self-Regulation Only
Food Literacy + Parent Education
Food Literacy Only
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring nutrition knowledge, food literacy, physical activity, executive function, emotion regulation, eating regulation, parenting, food parenting

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children ages 3 to 5 years enrolled in full-day, center-based childcare programs
  • Caregiver ≥ 18 years of age
  • Caregiver responsible for providing meals for child at least half of the time
  • Fluent in English (caregiver and child)

Exclusion Criteria:

  • Developmental delays or disorders that affect learning, mobility and eating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm 15

    Arm 16

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Healthy Eating, Active Play, Self-Regulation, Parent Education

    Healthy Eating, Active Play, Self-Regulation

    Healthy Eating, Active Play, Parent Education

    Healthy Eating + Active Play

    Healthy Eating, Self-Regulation, Parent Education

    Healthy Eating + Self-Regulation

    Healthy Eating + Parent Education

    Healthy Eating Only

    Active Play, Self-Regulation, Parent Education

    Active Play + Self-Regulation

    Active Play + Parent Education

    Active Play Only

    Self-Regulation + Parent Education

    Self-Regulation Only

    Food Literacy + Parent Education

    Food Literacy Only

    Arm Description

    Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education

    Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education

    Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education

    Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.

    Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.

    Outcomes

    Primary Outcome Measures

    Child Body Mass Index (BMI)
    Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight
    Nutrition Knowledge
    Ability to identify energy- vs. nutrient-dense foods using the Food Knowledge Procedure
    Food Choices
    Children's choices between energy- vs. nutrient-dense foods for a hypothetical lunch using the Snack Selection Procedure
    Physical and Sedentary Activity
    Children's engagement in sedentary and moderate-vigorous physical activity during the school day objectively measured via accelerometry.
    Children's Behavioral Regulation - Observed
    Behavioral tasks that measure child inhibitory control: Walk a Line Slowly, Peg/Pencil Tapping Procedure and Choosing Dinky Toys. Assessor reports of children's emotions, attention, and behavior: Preschool Self-Regulation Assessor Report
    Children's Behavioral Regulation - Parent- and Teacher-Report
    Teacher reports of children's attentional focusing, impulsivity and inhibitory control: Child Behavior Questionnaire Parent reports of children's impulsivity and inhibitory control: Child Behavior Questionnaire
    Children's Emotion Regulation - Parent- and Teacher-Report
    Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire
    Children's Eating in the Absence of Hunger
    Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.

    Secondary Outcome Measures

    Children's Appetitive Behaviors
    Parent report of children's appetitive trait-like behaviors (responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating, fussiness, emotional overeating, emotional undereating, and desire for drinks). Measured using the Children's Eating Behavior Questionnaire.
    Children's Food Requests
    Parental reports of children's requests for fruits, vegetables, whole grains and dairy.
    Parental reports of children's requests for fruits, vegetables, whole grains and dairy
    Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.

    Full Information

    First Posted
    September 7, 2020
    Last Updated
    March 4, 2021
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04552678
    Brief Title
    Healthy Bodies Project to Prevent Childhood Obesity
    Acronym
    Healthy Bodies
    Official Title
    Healthy Bodies Project: Modifying Family and Preschool Environments to Prevent Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (Actual)
    Primary Completion Date
    December 15, 2020 (Actual)
    Study Completion Date
    December 15, 2020 (Actual)

    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 study is to evaluate components of a preschool-based intervention designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. The long-term goal is to help children develop healthy habits that reduce risk for obesity.
    Detailed Description
    Findings from intervention studies designed to prevent obesity among preschool children are mixed. One approach to stemming the development of obesity in childhood is to alter children's choices and environments in ways that promote food literacy, acceptance of healthy foods, physical activity and self-regulation. Research on factors that influence the development of obesity in children has identified factors in children's environments that are potential targets for prevention programs. The goal of this study is to evaluate the efficacy of components designed for a preschool-based approach to preventing obesity in children. Using an innovative approach to optimizing behavioral interventions, the multiphase optimization strategy (MOST), we will examine the effects of a 28-week, randomized set of experiments designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. Participants will include over 1300 predominantly low-income preschool children ages 3 to 5 years attending center-based childcare settings in Pennsylvania (~100 classrooms). The proposed study will provide information on the most efficacious components that produce measurable changes in children's nutrition knowledge and obesity-related behaviors. The results of this study will be used to inform the design of a randomized controlled trial to prevent obesity in children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood
    Keywords
    nutrition knowledge, food literacy, physical activity, executive function, emotion regulation, eating regulation, parenting, food parenting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    The study utilizes a 2x4 factorial design with 16 conditions. Classrooms are the unit of randomization. Classrooms are randomized into 1 of 16 conditions that vary based on whether or not the following treatments are turned on or off: Healthy Eating Classroom Curriculum; Active Play Classroom Curriculum; Self-Regulation Classroom Curriculum; Enhanced Parent Education. All classrooms receive a Food Literacy curriculum.
    Masking
    Outcomes Assessor
    Masking Description
    Assessors who collect data from children are blind to study condition.
    Allocation
    Randomized
    Enrollment
    2480 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Eating, Active Play, Self-Regulation, Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education
    Arm Title
    Healthy Eating, Active Play, Self-Regulation
    Arm Type
    Experimental
    Arm Description
    Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education
    Arm Title
    Healthy Eating, Active Play, Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education
    Arm Title
    Healthy Eating + Active Play
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education
    Arm Title
    Healthy Eating, Self-Regulation, Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education
    Arm Title
    Healthy Eating + Self-Regulation
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education
    Arm Title
    Healthy Eating + Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education
    Arm Title
    Healthy Eating Only
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education
    Arm Title
    Active Play, Self-Regulation, Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education
    Arm Title
    Active Play + Self-Regulation
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education
    Arm Title
    Active Play + Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education
    Arm Title
    Active Play Only
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education
    Arm Title
    Self-Regulation + Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education
    Arm Title
    Self-Regulation Only
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education
    Arm Title
    Food Literacy + Parent Education
    Arm Type
    Experimental
    Arm Description
    Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.
    Arm Title
    Food Literacy Only
    Arm Type
    Experimental
    Arm Description
    Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating, Active Play, Self-Regulation, Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating, Active Play, Self-Regulation
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating, Active Play, Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating + Active Play
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating, Self-Regulation, Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating + Self-Regulation
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating + Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating Only
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Play, Self-Regulation, Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Play + Self-Regulation
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Play + Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Active Play Only
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-Regulation + Parent Education
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-Regulation Only
    Intervention Description
    In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Food Literacy + Parent Education
    Intervention Description
    Children in this condition will only receive a 27-lesson, core food literacy curriculum (children across all conditions will receive this curriculum). Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Food Literacy Only
    Intervention Description
    Children in this condition will only receive a 27-lesson, core food literacy curriculum (children across all conditions will receive this curriculum). Parents will receive access to web-based resources on food literacy.
    Primary Outcome Measure Information:
    Title
    Child Body Mass Index (BMI)
    Description
    Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight
    Time Frame
    Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
    Title
    Nutrition Knowledge
    Description
    Ability to identify energy- vs. nutrient-dense foods using the Food Knowledge Procedure
    Time Frame
    Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
    Title
    Food Choices
    Description
    Children's choices between energy- vs. nutrient-dense foods for a hypothetical lunch using the Snack Selection Procedure
    Time Frame
    Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
    Title
    Physical and Sedentary Activity
    Description
    Children's engagement in sedentary and moderate-vigorous physical activity during the school day objectively measured via accelerometry.
    Time Frame
    Change from Baseline to Mid-Intervention (~3 months), Post-Intervention (5-6 months) and follow-up (~9 months)
    Title
    Children's Behavioral Regulation - Observed
    Description
    Behavioral tasks that measure child inhibitory control: Walk a Line Slowly, Peg/Pencil Tapping Procedure and Choosing Dinky Toys. Assessor reports of children's emotions, attention, and behavior: Preschool Self-Regulation Assessor Report
    Time Frame
    Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
    Title
    Children's Behavioral Regulation - Parent- and Teacher-Report
    Description
    Teacher reports of children's attentional focusing, impulsivity and inhibitory control: Child Behavior Questionnaire Parent reports of children's impulsivity and inhibitory control: Child Behavior Questionnaire
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Children's Emotion Regulation - Parent- and Teacher-Report
    Description
    Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Children's Eating in the Absence of Hunger
    Description
    Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Secondary Outcome Measure Information:
    Title
    Children's Appetitive Behaviors
    Description
    Parent report of children's appetitive trait-like behaviors (responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating, fussiness, emotional overeating, emotional undereating, and desire for drinks). Measured using the Children's Eating Behavior Questionnaire.
    Time Frame
    Baseline, Post-Intervention (5-6 months)
    Title
    Children's Food Requests
    Description
    Parental reports of children's requests for fruits, vegetables, whole grains and dairy.
    Time Frame
    Baseline, Post-Intervention (5-6 months)
    Title
    Parental reports of children's requests for fruits, vegetables, whole grains and dairy
    Description
    Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.
    Time Frame
    Baseline, Post-Intervention (5-6 months)
    Other Pre-specified Outcome Measures:
    Title
    Food Parenting Practices
    Description
    Comprehensive Feeding Practices Questionnaire to assess parental monitoring, restriction, pressure to eat, modeling, teaching about nutrition, child involvement, using food for emotional regulation, using food as a reward, child control in eating, healthy food availability, and encouraging balance. Child Feeding Questionnaire to assess child picky eating, and parents' perception of time for healthy eating.
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Sociodemographics
    Description
    Parent Demographic Questionnaire to assess parent age, BMI, race, education, employment, marital status and household income.
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Parent Physical Activity
    Description
    International Physical Activity Questionnaire (IPAQ, short form) to classify parents as sedentary, moderately active or vigorously active.
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Family Media Use Patterns
    Description
    Family Media Patterns questionnaire developed by the research group to measure screen use and eating during televisions viewing in children and parents.
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Activity Parenting Practices
    Description
    Questionnaire to measure parents' use of TV viewing as a form of family recreation, frequency of TV viewing during mealtime and children's time spent watching television (TV) or playing on computer/phone/tablet.
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Child Sleep Patterns
    Description
    Parent report of children's sleep duration, sleep timing and napping patterns
    Time Frame
    Change from baseline to post-assessment (5-6months)
    Title
    Food Availability, Modeling and Encouragement
    Description
    Fruit and Vegetable, whole grain and dairy questionnaires, developed by the research team, to assess fruit, vegetable, whole grain and dairy availability in the home, parental encouragement to consume, and parental modeling of consumption.
    Time Frame
    Change from baseline to post-assessment (5-6months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children ages 3 to 5 years enrolled in full-day, center-based childcare programs Caregiver ≥ 18 years of age Caregiver responsible for providing meals for child at least half of the time Fluent in English (caregiver and child) Exclusion Criteria: Developmental delays or disorders that affect learning, mobility and eating
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lori A Francis, Ph.D.
    Organizational Affiliation
    The Pennsylvania State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no finalized plan for which and how individual participant data will be shared. This plan will be developed in collaboration with the sponsoring institution and funders.
    Links:
    URL
    https://sites.psu.edu/healthybodies/
    Description
    A child health and wellness research study funded by the U.S. Department of Agriculture (USDA)

    Learn more about this trial

    Healthy Bodies Project to Prevent Childhood Obesity

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