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Completed

NCT Number: NCT04552678

Healthy Bodies Project to Prevent Childhood 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.

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Key information

Conditions

Obesity, Childhood Behavior Body Weight Emotional Regulation Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Self-Control Signs and Symptoms Social Behavior

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Eating, Active Play, Self-Regulation, Parent Education

Behavioral

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.

Healthy Eating, Active Play, Self-Regulation

Behavioral

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.

Healthy Eating, Active Play, Parent Education

Behavioral

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.

Healthy Eating + Active Play

Behavioral

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.

Healthy Eating, Self-Regulation, Parent Education

Behavioral

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.

Healthy Eating + Self-Regulation

Behavioral

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.

Healthy Eating + Parent Education

Behavioral

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.

Healthy Eating Only

Behavioral

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.

Active Play, Self-Regulation, Parent Education

Behavioral

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.

Active Play + Self-Regulation

Behavioral

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.

Active Play + Parent Education

Behavioral

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.

Active Play Only

Behavioral

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.

Self-Regulation + Parent Education

Behavioral

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.

Self-Regulation Only

Behavioral

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.

Food Literacy + Parent Education

Behavioral

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.

Food Literacy Only

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  1. Children's Appetitive Behaviors

    Time frame: 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.

  2. Children's Food Requests

    Time frame: Baseline, Post-Intervention (5-6 months)

    Parental reports of children's requests for fruits, vegetables, whole grains and dairy.

  3. Parental reports of children's requests for fruits, vegetables, whole grains and dairy

    Time frame: 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.

Other outcomes

  1. Food Parenting Practices

    Time frame: Change 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.

  2. Sociodemographics

    Time frame: Change from baseline to post-assessment (5-6months)

    Parent Demographic Questionnaire to assess parent age, BMI, race, education, employment, marital status and household income.

  3. Parent Physical Activity

    Time frame: Change from baseline to post-assessment (5-6months)

    International Physical Activity Questionnaire (IPAQ, short form) to classify parents as sedentary, moderately active or vigorously active.

  4. Family Media Use Patterns

    Time frame: Change 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.

  5. Activity Parenting Practices

    Time frame: Change 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.

  6. Child Sleep Patterns

    Time frame: Change from baseline to post-assessment (5-6months)

    Parent report of children's sleep duration, sleep timing and napping patterns

  7. Food Availability, Modeling and Encouragement

    Time frame: Change 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.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Acronym: Healthy Bodies

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2020
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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