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Healthy Bodies Project to Prevent Childhood Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04552678
Acronym
Healthy Bodies
Enrollment
2480
Registered
2020-09-17
Start date
2015-08-31
Completion date
2020-12-15
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

nutrition knowledge, food literacy, physical activity, executive function, emotion regulation, eating regulation, parenting, food parenting

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.

Interventions

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALHealthy 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.

BEHAVIORALActive 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.

BEHAVIORALActive 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.

BEHAVIORALActive 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.

BEHAVIORALActive 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.

BEHAVIORALSelf-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.

BEHAVIORALSelf-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.

BEHAVIORALFood 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.

BEHAVIORALFood 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.

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors who collect data from children are blind to study condition.

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Children's Emotion Regulation - Parent- and Teacher-ReportChange from baseline to post-assessment (5-6months)Parent and Teacher reports of children's anger/frustration: Child Behavior Questionnaire
Nutrition KnowledgeChange 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
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 - Parent- and Teacher-ReportChange 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 Behavioral Regulation - ObservedChange 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
Physical and Sedentary ActivityChange 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.
Food ChoicesChange 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
Children's Eating in the Absence of HungerChange 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

MeasureTime frameDescription
Parental reports of children's requests for fruits, vegetables, whole grains and dairyBaseline, 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.
Children's Appetitive BehaviorsBaseline, 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.
Children's Food RequestsBaseline, Post-Intervention (5-6 months)Parental reports of children's requests for fruits, vegetables, whole grains and dairy.

Other

MeasureTime frameDescription
Food Parenting PracticesChange from baseline to post-assessment (5-6months)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.
Food Availability, Modeling and EncouragementChange from baseline to post-assessment (5-6months)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.
Child Sleep PatternsChange from baseline to post-assessment (5-6months)Parent report of children's sleep duration, sleep timing and napping patterns
Activity Parenting PracticesChange from baseline to post-assessment (5-6months)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.
Parent Physical ActivityChange from baseline to post-assessment (5-6months)International Physical Activity Questionnaire (IPAQ, short form) to classify parents as sedentary, moderately active or vigorously active.
SociodemographicsChange from baseline to post-assessment (5-6months)Parent Demographic Questionnaire to assess parent age, BMI, race, education, employment, marital status and household income.
Family Media Use PatternsChange from baseline to post-assessment (5-6months)Family Media Patterns questionnaire developed by the research group to measure screen use and eating during televisions viewing in children and parents.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026