An interventional study of Healthy Eating, Active Play, Self-Regulation, Parent Education and Healthy Eating, Active Play, Self-Regulation in Obesity, Childhood, sponsored by Penn State University. Completed. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 2,480 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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Exclusion Criteria:
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
Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education
Behavioral: Healthy Eating, Active Play, Self-Regulation
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
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education
Behavioral: Healthy Eating + Active Play
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
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education
Behavioral: Healthy Eating + Self-Regulation
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education
Behavioral: Healthy Eating + Parent Education
Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education
Behavioral: Healthy Eating Only
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
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education
Behavioral: Active Play + Self-Regulation
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education
Behavioral: Active Play + Parent Education
Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education
Behavioral: Active Play Only
Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education
Behavioral: Self-Regulation + Parent Education
Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education
Behavioral: Self-Regulation Only
Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules.
Behavioral: Food Literacy + Parent Education
Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education.
Behavioral: Food Literacy 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, 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Child Body Mass Index (BMI)
Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Change from baseline to post-assessment (5-6months)
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.
Time frame: Baseline, Post-Intervention (5-6 months)
Children's Food Requests
Parental reports of children's requests for fruits, vegetables, whole grains and dairy.
Time frame: 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.
Time frame: Baseline, Post-Intervention (5-6 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to post-assessment (5-6months)
Child Sleep Patterns
Parent report of children's sleep duration, sleep timing and napping patterns
Time frame: 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.
Time frame: Change from baseline to post-assessment (5-6months)
No study locations are listed for this record.
Plan to share: No — 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.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Penn State University