Healthy Bodies Project to Prevent Childhood Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Healthy Bodies Project: Modifying Family and Preschool Environments to Prevent Obesity

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent Education
* Behavioral: Healthy Eating, Active Play, Self-Regulation
* Behavioral: Healthy Eating, Active Play, Parent Education
* Behavioral: Healthy Eating + Active Play
* Behavioral: Healthy Eating, Self-Regulation, Parent Education
* Behavioral: Healthy Eating + Self-Regulation
* Behavioral: Healthy Eating + Parent Education
* Behavioral: Healthy Eating Only
* Behavioral: Active Play, Self-Regulation, Parent Education
* Behavioral: Active Play + Self-Regulation
* Behavioral: Active Play + Parent Education
* Behavioral: Active Play Only
* Behavioral: Self-Regulation + Parent Education
* Behavioral: Self-Regulation Only
* Behavioral: Food Literacy + Parent Education
* Behavioral: Food Literacy Only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Eating, Active Play, Self-Regulation, Parent Education<br>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<br>* 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.<br>|
| Experimental: Healthy Eating, Active Play, Self-Regulation<br>Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education | Behavioral: Healthy Eating, Active Play, Self-Regulation<br>* 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.<br>|
| Experimental: Healthy Eating, Active Play, Parent Education<br>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<br>* 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.<br>|
| Experimental: Healthy Eating + Active Play<br>Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education | Behavioral: Healthy Eating + Active Play<br>* 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.<br>|
| Experimental: Healthy Eating, Self-Regulation, Parent Education<br>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<br>* 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.<br>|
| Experimental: Healthy Eating + Self-Regulation<br>Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education | Behavioral: Healthy Eating + Self-Regulation<br>* 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.<br>|
| Experimental: Healthy Eating + Parent Education<br>Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education | Behavioral: Healthy Eating + Parent Education<br>* 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.<br>|
| Experimental: Healthy Eating Only<br>Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education | Behavioral: Healthy Eating Only<br>* 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.<br>|
| Experimental: Active Play, Self-Regulation, Parent Education<br>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<br>* 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.<br>|
| Experimental: Active Play + Self-Regulation<br>Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education | Behavioral: Active Play + Self-Regulation<br>* 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.<br>|
| Experimental: Active Play + Parent Education<br>Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education | Behavioral: Active Play + Parent Education<br>* 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.<br>|
| Experimental: Active Play Only<br>Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education | Behavioral: Active Play Only<br>* 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.<br>|
| Experimental: Self-Regulation + Parent Education<br>Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education | Behavioral: Self-Regulation + Parent Education<br>* 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.<br>|
| Experimental: Self-Regulation Only<br>Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education | Behavioral: Self-Regulation Only<br>* 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.<br>|
| Experimental: Food Literacy + Parent Education<br>Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules. | Behavioral: Food Literacy + Parent Education<br>* 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.<br>|
| Experimental: Food Literacy Only<br>Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education. | Behavioral: Food Literacy Only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Post-Intervention (5-6 months) | 
| Children's Food Requests | Parental reports of children's requests for fruits, vegetables, whole grains and dairy. | Baseline, Post-Intervention (5-6 months) | 
| 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. | Baseline, Post-Intervention (5-6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition knowledge, food literacy, physical activity, executive function, emotion regulation, eating regulation, parenting, food parenting