Clinical trial NCT04552678: Healthy Bodies Project to Prevent Childhood Obesity
Official title: Healthy Bodies Project: Modifying Family and Preschool Environments to Prevent Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: nutrition knowledge
food literacy
physical activity
executive function
emotion regulation
eating regulation
parenting
food parenting
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 2480
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Child Body Mass Index (BMI)
timeFrame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
measure: Nutrition Knowledge
timeFrame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
measure: Food Choices
timeFrame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
measure: Physical and Sedentary Activity
timeFrame: Change from Baseline to Mid-Intervention (~3 months), Post-Intervention (5-6 months) and follow-up (~9 months)
measure: Children's Behavioral Regulation - Observed
timeFrame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
measure: Children's Behavioral Regulation - Parent- and Teacher-Report
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Children's Emotion Regulation - Parent- and Teacher-Report
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Children's Eating in the Absence of Hunger
timeFrame: Change from baseline to post-assessment (5-6months)
Secondary outcomes:
measure: Children's Appetitive Behaviors
timeFrame: Baseline, Post-Intervention (5-6 months)
measure: Children's Food Requests
timeFrame: Baseline, Post-Intervention (5-6 months)
measure: Parental reports of children's requests for fruits, vegetables, whole grains and dairy
timeFrame: Baseline, Post-Intervention (5-6 months)
Other outcomes:
measure: Food Parenting Practices
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Sociodemographics
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Parent Physical Activity
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Family Media Use Patterns
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Activity Parenting Practices
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Child Sleep Patterns
timeFrame: Change from baseline to post-assessment (5-6months)
measure: Food Availability, Modeling and Encouragement
timeFrame: Change from baseline to post-assessment (5-6months)
Locations:
Study officials:
affiliation: The Pennsylvania State University
name: Lori A Francis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: