Healthy Bodies Project: Modifying Family and Preschool Environments to Prevent Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 2,480
- Primary Endpoint
- Food Choices
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessors who collect data from children are blind to study condition.
Eligibility Criteria
- Ages
- 3 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy Eating, Active Play, Self-Regulation, Parent Education
Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education
Intervention: Healthy Eating, Active Play, Self-Regulation, Parent Education (Behavioral)
Healthy Eating, Active Play, Self-Regulation
Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education
Intervention: Healthy Eating, Active Play, Self-Regulation (Behavioral)
Healthy Eating, Active Play, Parent Education
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education
Intervention: Healthy Eating, Active Play, Parent Education (Behavioral)
Healthy Eating + Active Play
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education
Intervention: Healthy Eating + Active Play (Behavioral)
Healthy Eating, Self-Regulation, Parent Education
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education
Intervention: Healthy Eating, Self-Regulation, Parent Education (Behavioral)
Healthy Eating + Self-Regulation
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education
Intervention: Healthy Eating + Self-Regulation (Behavioral)
Healthy Eating + Parent Education
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education
Intervention: Healthy Eating + Parent Education (Behavioral)
Healthy Eating Only
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education
Intervention: Healthy Eating Only (Behavioral)
Active Play, Self-Regulation, Parent Education
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education
Intervention: Active Play, Self-Regulation, Parent Education (Behavioral)
Active Play + Self-Regulation
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education
Intervention: Active Play + Self-Regulation (Behavioral)
Active Play + Parent Education
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education
Intervention: Active Play + Parent Education (Behavioral)
Active Play Only
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education
Intervention: Active Play Only (Behavioral)
Self-Regulation + Parent Education
Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education
Intervention: Self-Regulation + Parent Education (Behavioral)
Self-Regulation Only
Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education
Intervention: Self-Regulation Only (Behavioral)
Food Literacy + Parent Education
Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.
Intervention: Food Literacy + Parent Education (Behavioral)
Food Literacy Only
Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.
Intervention: Food Literacy Only (Behavioral)
Outcomes
Primary Outcomes
Food Choices
Time Frame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Children's choices between energy- vs. nutrient-dense foods for a hypothetical lunch using the Snack Selection Procedure
Child Body Mass Index (BMI)
Time Frame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight
Children's Behavioral Regulation - Observed
Time Frame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
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
Nutrition Knowledge
Time Frame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Ability to identify energy- vs. nutrient-dense foods using the Food Knowledge Procedure
Physical and Sedentary Activity
Time Frame: Change from Baseline to Mid-Intervention (~3 months), Post-Intervention (5-6 months) and follow-up (~9 months)
Children's engagement in sedentary and moderate-vigorous physical activity during the school day objectively measured via accelerometry.
Children's Behavioral Regulation - Parent- and Teacher-Report
Time Frame: Change from baseline to post-assessment (5-6months)
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
Time Frame: Change from baseline to post-assessment (5-6months)
Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire
Children's Eating in the Absence of Hunger
Time Frame: Change from baseline to post-assessment (5-6months)
Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.
Secondary Outcomes
- Children's Food Requests(Baseline, Post-Intervention (5-6 months))
- Children's Appetitive Behaviors(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))
Investigators
Lori Francis
Associate Professor of Biobehavioral Health
Penn State University