Healthy Bodies Project to Prevent Childhood Obesity
- Conditions
- Obesity, Childhood
- Interventions
- Behavioral: Healthy Eating, Active Play, Self-RegulationBehavioral: Healthy Eating OnlyBehavioral: Healthy Eating, Active Play, Self-Regulation, Parent EducationBehavioral: Healthy Eating, Active Play, Parent EducationBehavioral: Healthy Eating + Active PlayBehavioral: Healthy Eating + Parent EducationBehavioral: Active Play + Self-RegulationBehavioral: Active Play + Parent EducationBehavioral: Active Play OnlyBehavioral: Self-Regulation + Parent EducationBehavioral: Food Literacy + Parent EducationBehavioral: Healthy Eating, Self-Regulation, Parent EducationBehavioral: Healthy Eating + Self-RegulationBehavioral: Self-Regulation OnlyBehavioral: Active Play, Self-Regulation, Parent EducationBehavioral: Food Literacy Only
- Registration Number
- NCT04552678
- Lead Sponsor
- Penn State University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2480
- 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)
- Developmental delays or disorders that affect learning, mobility and eating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Healthy Eating, Active Play, Self-Regulation Healthy Eating, Active Play, Self-Regulation Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education Healthy Eating Only Healthy Eating Only Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education Healthy Eating, Active Play, Self-Regulation, Parent Education Healthy Eating, Active Play, Self-Regulation, Parent Education Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education Healthy Eating, Active Play, Parent Education Healthy Eating, Active Play, Parent Education Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education Healthy Eating + Active Play Healthy Eating + Active Play Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education Healthy Eating + Parent Education Healthy Eating + Parent Education Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education Active Play + Self-Regulation Active Play + Self-Regulation Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education Active Play + Parent Education Active Play + Parent Education Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education Active Play Only Active Play Only Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education Self-Regulation + Parent Education Self-Regulation + Parent Education Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education Food Literacy + Parent Education Food Literacy + Parent Education Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules. Healthy Eating, Self-Regulation, Parent Education Healthy Eating, Self-Regulation, Parent Education Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education Healthy Eating + Self-Regulation Healthy Eating + Self-Regulation Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education Self-Regulation Only Self-Regulation Only Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education Active Play, Self-Regulation, Parent Education Active Play, Self-Regulation, Parent Education Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education Food Literacy Only Food Literacy Only Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.
- Primary Outcome Measures
Name Time Method Child Body Mass Index (BMI) 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 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 ReportNutrition Knowledge 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
Food Choices 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
Physical and Sedentary Activity 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 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 QuestionnaireChildren's Emotion Regulation - Parent- and Teacher-Report 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 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 Outcome Measures
Name Time Method Children's Food Requests Baseline, Post-Intervention (5-6 months) Parental reports of children's requests for fruits, vegetables, whole grains and dairy.
Children's Appetitive Behaviors Baseline, Post-Intervention (5-6 months) 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.
Parental reports of children's requests for fruits, vegetables, whole grains and dairy Baseline, Post-Intervention (5-6 months) Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.