Skip to main content
Clinical Trials/NCT04552678
NCT04552678
Completed
N/A

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

Penn State University0 sites2,480 target enrollmentAugust 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Penn State University
Enrollment
2480
Primary Endpoint
Child Body Mass Index (BMI)
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
December 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lori Francis

Associate Professor of Biobehavioral Health

Penn State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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))

Similar Trials