Healthy Bodies Project to Prevent Childhood Obesity

Obesity, Childhood Clinical Trial

— Healthy Bodies  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552678
• Other study ID #: 2015-68001-23233
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2021
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2480
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Child Sleep Patterns	Parent report of children's sleep duration, sleep timing and napping patterns	Change from baseline to post-assessment (5-6months)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Children's Food Requests	Parental reports of children's requests for fruits, vegetables, whole grains and dairy.	Baseline, Post-Intervention (5-6 months)
Secondary	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)

External Links

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