Healthy Bodies Project to Prevent Childhood Obesity (Healthy Bodies)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent Education; Behavioral: Healthy Eating, Active Play, Self-Regulation; Behavioral: Healthy Eating, Active Play, Parent Education; Behavioral: Healthy Eating + Active Play; Behavioral: Healthy Eating, Self-Regulation, Parent Education; Behavioral: Healthy Eating + Self-Regulation; Behavioral: Healthy Eating + Parent Education; Behavioral: Healthy Eating Only; Behavioral: Active Play, Self-Regulation, Parent Education; Behavioral: Active Play + Self-Regulation; Behavioral: Active Play + Parent Education; Behavioral: Active Play Only; Behavioral: Self-Regulation + Parent Education; Behavioral: Self-Regulation Only; Behavioral: Food Literacy + Parent Education; Behavioral: Food Literacy Only

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 Type: Interventional
• Enrollment (Actual): 2480
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Eating, Active Play, Self-Regulation, Parent Education; Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education	Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Healthy Eating, Active Play, Self-Regulation; Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education	Behavioral: Healthy Eating, Active Play, Self-Regulation; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Healthy Eating, Active Play, Parent Education; Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education	Behavioral: Healthy Eating, Active Play, Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Healthy Eating + Active Play; Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education	Behavioral: Healthy Eating + Active Play; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Healthy Eating, Self-Regulation, Parent Education; Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education	Behavioral: Healthy Eating, Self-Regulation, Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Healthy Eating + Self-Regulation; Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education	Behavioral: Healthy Eating + Self-Regulation; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Healthy Eating + Parent Education; Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education	Behavioral: Healthy Eating + Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Healthy Eating Only; Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education	Behavioral: Healthy Eating Only; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Active Play, Self-Regulation, Parent Education; Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education	Behavioral: Active Play, Self-Regulation, Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Active Play + Self-Regulation; Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education	Behavioral: Active Play + Self-Regulation; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Active Play + Parent Education; Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education	Behavioral: Active Play + Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Active Play Only; Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education	Behavioral: Active Play Only; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Self-Regulation + Parent Education; Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education	Behavioral: Self-Regulation + Parent Education; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Self-Regulation Only; Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education	Behavioral: Self-Regulation Only; In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
Experimental: Food Literacy + Parent Education; Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.	Behavioral: Food Literacy + Parent Education; Children in this condition will only receive a 27-lesson, core food literacy curriculum (children across all conditions will receive this curriculum). Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
Experimental: Food Literacy Only; Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.	Behavioral: Food Literacy Only; Children in this condition will only receive a 27-lesson, core food literacy curriculum (children across all conditions will receive this curriculum). Parents will receive access to web-based resources on food literacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Body Mass Index (BMI)	Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight	Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Nutrition Knowledge	Ability to identify energy- vs. nutrient-dense foods using the Food Knowledge Procedure	Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Food Choices	Children's choices between energy- vs. nutrient-dense foods for a hypothetical lunch using the Snack Selection Procedure	Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Physical and Sedentary Activity	Children's engagement in sedentary and moderate-vigorous physical activity during the school day objectively measured via accelerometry.	Change from Baseline to Mid-Intervention (~3 months), Post-Intervention (5-6 months) and follow-up (~9 months)
Children's Behavioral Regulation - Observed	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	Change from baseline to post-assessment (5-6months) and follow-up (~9 months)
Children's Behavioral Regulation - Parent- and Teacher-Report	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	Change from baseline to post-assessment (5-6months)
Children's Emotion Regulation - Parent- and Teacher-Report	Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire	Change from baseline to post-assessment (5-6months)
Children's Eating in the Absence of Hunger	Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.	Change from baseline to post-assessment (5-6months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Appetitive Behaviors	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.	Baseline, Post-Intervention (5-6 months)
Children's Food Requests	Parental reports of children's requests for fruits, vegetables, whole grains and dairy.	Baseline, Post-Intervention (5-6 months)
Parental reports of children's requests for fruits, vegetables, whole grains and dairy	Parent reported measure of children's eating in the absence of hunger due to negative emotions, fatigue/boredom, or external food cues.	Baseline, Post-Intervention (5-6 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Parenting Practices	Comprehensive Feeding Practices Questionnaire to assess parental monitoring, restriction, pressure to eat, modeling, teaching about nutrition, child involvement, using food for emotional regulation, using food as a reward, child control in eating, healthy food availability, and encouraging balance. Child Feeding Questionnaire to assess child picky eating, and parents' perception of time for healthy eating.	Change from baseline to post-assessment (5-6months)
Sociodemographics	Parent Demographic Questionnaire to assess parent age, BMI, race, education, employment, marital status and household income.	Change from baseline to post-assessment (5-6months)
Parent Physical Activity	International Physical Activity Questionnaire (IPAQ, short form) to classify parents as sedentary, moderately active or vigorously active.	Change from baseline to post-assessment (5-6months)
Family Media Use Patterns	Family Media Patterns questionnaire developed by the research group to measure screen use and eating during televisions viewing in children and parents.	Change from baseline to post-assessment (5-6months)
Activity Parenting Practices	Questionnaire to measure parents' use of TV viewing as a form of family recreation, frequency of TV viewing during mealtime and children's time spent watching television (TV) or playing on computer/phone/tablet.	Change from baseline to post-assessment (5-6months)
Child Sleep Patterns	Parent report of children's sleep duration, sleep timing and napping patterns	Change from baseline to post-assessment (5-6months)
Food Availability, Modeling and Encouragement	Fruit and Vegetable, whole grain and dairy questionnaires, developed by the research team, to assess fruit, vegetable, whole grain and dairy availability in the home, parental encouragement to consume, and parental modeling of consumption.	Change from baseline to post-assessment (5-6months)

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Lori A Francis, Ph.D., The Pennsylvania State University

Publications and helpful links

Helpful Links

• A child health and wellness research study funded by the U.S. Department of Agriculture (USDA)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; parenting; executive function; emotion regulation; eating regulation; nutrition knowledge; food literacy; food parenting
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2015-68001-23233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no finalized plan for which and how individual participant data will be shared. This plan will be developed in collaboration with the sponsoring institution and funders.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No