Healthy Bodies Project to Prevent Childhood Obesity

NCT04552678 | Completed

• 1 other identifier: 2015-68001-23233
• Study Type: interventional
• Target: 2,480
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity, Childhood

Keywords

nutrition knowledge; food literacy; physical activity; executive function; emotion regulation; eating regulation; parenting; food parenting

Outcome Measures

Primary Outcomes (8)

• Child Body Mass Index (BMI)

  Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight

  Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

• Nutrition Knowledge

  Ability to identify energy- vs. nutrient-dense foods using the Food Knowledge Procedure

  Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

• Food Choices

  Children's choices between energy- vs. nutrient-dense foods for a hypothetical lunch using the Snack Selection Procedure

  Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

• Physical and Sedentary Activity

  Children's engagement in sedentary and moderate-vigorous physical activity during the school day objectively measured via accelerometry.

  Change from Baseline to Mid-Intervention (~3 months), Post-Intervention (5-6 months) and follow-up (~9 months)

• 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

  Change from baseline to post-assessment (5-6months) and follow-up (~9 months)

• 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

  Change from baseline to post-assessment (5-6months)

• Children's Emotion Regulation - Parent- and Teacher-Report

  Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire

  Change from baseline to post-assessment (5-6months)

• 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.

  Change from baseline to post-assessment (5-6months)

Secondary Outcomes (3)

• Children's Appetitive Behaviors

  Baseline, Post-Intervention (5-6 months)

• Children's Food Requests

  Baseline, Post-Intervention (5-6 months)

• Parental reports of children's requests for fruits, vegetables, whole grains and dairy

  Baseline, Post-Intervention (5-6 months)

Other Outcomes (7)

• Food Parenting Practices

  Change from baseline to post-assessment (5-6months)

• Sociodemographics

  Change from baseline to post-assessment (5-6months)

• Parent Physical Activity

  Change from baseline to post-assessment (5-6months)

Study Arms (16)

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

EXPERIMENTAL

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

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

Healthy Eating, Active Play, Self-Regulation

EXPERIMENTAL

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

Behavioral: Healthy Eating, Active Play, Self-Regulation

Healthy Eating, Active Play, Parent Education

EXPERIMENTAL

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

Behavioral: Healthy Eating, Active Play, Parent Education

Healthy Eating + Active Play

EXPERIMENTAL

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

Behavioral: Healthy Eating + Active Play

Healthy Eating, Self-Regulation, Parent Education

EXPERIMENTAL

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

Behavioral: Healthy Eating, Self-Regulation, Parent Education

Healthy Eating + Self-Regulation

EXPERIMENTAL

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

Behavioral: Healthy Eating + Self-Regulation

Healthy Eating + Parent Education

EXPERIMENTAL

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

Behavioral: Healthy Eating + Parent Education

Healthy Eating Only

EXPERIMENTAL

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

Behavioral: Healthy Eating Only

Active Play, Self-Regulation, Parent Education

EXPERIMENTAL

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

Behavioral: Active Play, Self-Regulation, Parent Education

Active Play + Self-Regulation

EXPERIMENTAL

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

Behavioral: Active Play + Self-Regulation

Active Play + Parent Education

EXPERIMENTAL

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

Behavioral: Active Play + Parent Education

Active Play Only

EXPERIMENTAL

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

Behavioral: Active Play Only

Self-Regulation + Parent Education

EXPERIMENTAL

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

Behavioral: Self-Regulation + Parent Education

Self-Regulation Only

EXPERIMENTAL

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

Behavioral: Self-Regulation Only

Food Literacy + Parent Education

EXPERIMENTAL

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

Behavioral: Food Literacy + Parent Education

Food Literacy Only

EXPERIMENTAL

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

Behavioral: Food Literacy Only

Interventions

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

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.

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

Healthy Eating, Active Play, Self-Regulation BEHAVIORAL

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.

Healthy Eating, Active Play, Self-Regulation

Healthy Eating, Active Play, Parent Education BEHAVIORAL

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.

Healthy Eating, Active Play, Parent Education

Healthy Eating + Active Play BEHAVIORAL

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.

Healthy Eating + Active Play

Healthy Eating, Self-Regulation, Parent Education BEHAVIORAL

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.

Healthy Eating, Self-Regulation, Parent Education

Healthy Eating + Self-Regulation BEHAVIORAL

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.

Healthy Eating + Self-Regulation

Healthy Eating + Parent Education BEHAVIORAL

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.

Healthy Eating + Parent Education

Healthy Eating Only BEHAVIORAL

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.

Healthy Eating Only

Active Play, Self-Regulation, Parent Education BEHAVIORAL

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.

Active Play, Self-Regulation, Parent Education

Active Play + Self-Regulation BEHAVIORAL

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.

Active Play + Self-Regulation

Active Play + Parent Education BEHAVIORAL

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.

Active Play + Parent Education

Active Play Only BEHAVIORAL

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.

Active Play Only

Self-Regulation + Parent Education BEHAVIORAL

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.

Self-Regulation + Parent Education

Self-Regulation Only BEHAVIORAL

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.

Self-Regulation Only

Food Literacy + Parent Education BEHAVIORAL

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.

Food Literacy + Parent Education

Food Literacy Only BEHAVIORAL

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.

Food Literacy Only

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Penn State University: lead

Related Links

• A child health and wellness research study funded by the U.S. Department of Agriculture (USDA)

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity; Emotional Regulation

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lori A Francis, Ph.D.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who collect data from children are blind to study condition.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biobehavioral Health

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 17, 2020
• Study Start: August 1, 2015
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share