Healthy Bodies Project to Prevent Childhood Obesity

Not Applicable

Completed

• Conditions: Obesity, Childhood

• 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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 Report
Nutrition 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 Questionnaire
Children'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.