Obesity, ChildhoodHealthy BodiesNCT04552678
Healthy Bodies Project to Prevent Childhood Obesity
A study testing Healthy Eating, Active Play, Self-Regulation, Parent Education, Healthy Eating, Active Play, Self-Regulation and Healthy Eating, Active Play, Parent Education in people with Obesity, Childhood, run by Penn State University.
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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Healthy Eating, Active Play, Self-Regulation, Parent Education, Healthy Eating, Active Play, Self-Regulation and Healthy Eating, Active Play, Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Developmental delays or disorders that affect learning, mobility and eating
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- Healthy Eating, Active Play, Self-Regulation, Parent Education, Healthy Eating, Active Play, Self-Regulation, Healthy Eating, Active Play, Parent Education, Healthy Eating + Active Play, Healthy Eating, Self-Regulation, Parent Education
- Keywords
- nutrition knowledge, food literacy, physical activity, executive function, emotion regulation, eating regulation, parenting, food parenting
- Medical subject headings
- Pediatric Obesity, Motor Activity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating, Active Play, Self-Regulation, Parent EducationBehavioural
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-RegulationBehavioural
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 EducationBehavioural
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 PlayBehavioural
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 EducationBehavioural
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-RegulationBehavioural
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 EducationBehavioural
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 OnlyBehavioural
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 EducationBehavioural
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-RegulationBehavioural
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 EducationBehavioural
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 OnlyBehavioural
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 EducationBehavioural
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 OnlyBehavioural
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 EducationBehavioural
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 OnlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Eating, Active Play, Self-Regulation, Parent Education | Experimental | Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education Receives: Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent Education |
| Healthy Eating, Active Play, Self-Regulation | Experimental | Classrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education Receives: Behavioral: Healthy Eating, Active Play, Self-Regulation |
| Healthy Eating, Active Play, Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education Receives: Behavioral: Healthy Eating, Active Play, Parent Education |
| Healthy Eating + Active Play | Experimental | Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education Receives: Behavioral: Healthy Eating + Active Play |
| Healthy Eating, Self-Regulation, Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education Receives: Behavioral: Healthy Eating, Self-Regulation, Parent Education |
| Healthy Eating + Self-Regulation | Experimental | Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education Receives: Behavioral: Healthy Eating + Self-Regulation |
| Healthy Eating + Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education Receives: Behavioral: Healthy Eating + Parent Education |
| Healthy Eating Only | Experimental | Classrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education Receives: Behavioral: Healthy Eating Only |
| Active Play, Self-Regulation, Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education Receives: Behavioral: Active Play, Self-Regulation, Parent Education |
| Active Play + Self-Regulation | Experimental | Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education Receives: Behavioral: Active Play + Self-Regulation |
| Active Play + Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education Receives: Behavioral: Active Play + Parent Education |
| Active Play Only | Experimental | Classrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education Receives: Behavioral: Active Play Only |
| Self-Regulation + Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education Receives: Behavioral: Self-Regulation + Parent Education |
| Self-Regulation Only | Experimental | Classrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education Receives: Behavioral: Self-Regulation Only |
| Food Literacy + Parent Education | Experimental | Classrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules. Receives: Behavioral: Food Literacy + Parent Education |
| Food Literacy Only | Experimental | Classrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education. Receives: Behavioral: Food Literacy Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Mass Index (BMI)
Absolute BMI, BMI z-score (BMIz), BMI percentile (BMIp) calculated from measured height and weight
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline to post-assessment (5-6months)
Secondary outcomes (3)
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.
Measured: Baseline, Post-Intervention (5-6 months)
Children's Food Requests
Parental reports of children's requests for fruits, vegetables, whole grains and dairy.
Measured: 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.
Measured: Baseline, Post-Intervention (5-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study startAug 2015
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Francis, Penn State University
- Investigators
- Lori A Francis, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552678
- Sponsor's protocol ID
- 2015-68001-23233
- Other IDs
- 2015
- Acronym
- Healthy Bodies
- Status last verified
- Mar 2021
- First submitted
- 7 Sep 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Bodies Project: Modifying Family and Preschool Environments to Prevent Obesity
- ClinicalTrials.gov ID
- NCT04552678
- Acronym / sponsor ID
- Healthy Bodies / 2015-68001-23233
- Conditions
- Obesity, Childhood
- Keywords
- nutrition knowledge, food literacy, physical activity, executive function, emotion regulation, eating regulation, parenting, food parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,480 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating, Active Play, Self-Regulation, Parent Education | Experimental | Behavioral: Healthy Eating, Active Play, Self-Regulation, Parent EducationClassrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum) and Parent Education |
| Healthy Eating, Active Play, Self-Regulation | Experimental | Behavioral: Healthy Eating, Active Play, Self-RegulationClassrooms receive all curricula (Food Literacy, Healthy Eating, Active Play, Self-Regulation Curriculum), but no Parent Education |
| Healthy Eating, Active Play, Parent Education | Experimental | Behavioral: Healthy Eating, Active Play, Parent EducationClassrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, and Parent Education |
| Healthy Eating + Active Play | Experimental | Behavioral: Healthy Eating + Active PlayClassrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Active Play Curriculum, but no Parent Education |
| Healthy Eating, Self-Regulation, Parent Education | Experimental | Behavioral: Healthy Eating, Self-Regulation, Parent EducationClassrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, and Parent Education |
| Healthy Eating + Self-Regulation | Experimental | Behavioral: Healthy Eating + Self-RegulationClassrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, the Self-Regulation Curriculum, but no Parent Education |
| Healthy Eating + Parent Education | Experimental | Behavioral: Healthy Eating + Parent EducationClassrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, and Parent Education |
| Healthy Eating Only | Experimental | Behavioral: Healthy Eating OnlyClassrooms receive the core Food Literacy Curriculum, the Healthy Eating Curriculum, but no Parent Education |
| Active Play, Self-Regulation, Parent Education | Experimental | Behavioral: Active Play, Self-Regulation, Parent EducationClassrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, and Parent Education |
| Active Play + Self-Regulation | Experimental | Behavioral: Active Play + Self-RegulationClassrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, the Self-Regulation Curriculum, but no Parent Education |
| Active Play + Parent Education | Experimental | Behavioral: Active Play + Parent EducationClassrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, and Parent Education |
| Active Play Only | Experimental | Behavioral: Active Play OnlyClassrooms receive the core Food Literacy Curriculum, the Active Play Curriculum, but no Parent Education |
| Self-Regulation + Parent Education | Experimental | Behavioral: Self-Regulation + Parent EducationClassrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, and Parent Education |
| Self-Regulation Only | Experimental | Behavioral: Self-Regulation OnlyClassrooms receive the core Food Literacy Curriculum, the Self-Regulation Curriculum, but no Parent Education |
| Food Literacy + Parent Education | Experimental | Behavioral: Food Literacy + Parent EducationClassrooms receive the core Food Literacy Curriculum, and parents are invited to complete web-based education modules. |
| Food Literacy Only | Experimental | Behavioral: Food Literacy OnlyClassrooms only receive the core Food Literacy Curriculum, and no other intervention materials or parent education. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Developmental delays or disorders that affect learning, mobility and eating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Eating, Active Play, Self-Regulation, Parent EducationIn 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. | Behavioural | Healthy Eating, Active Play, Self-Regulation, Parent Education |
| Healthy Eating, Active Play, Self-RegulationIn 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. | Behavioural | Healthy Eating, Active Play, Self-Regulation |
| Healthy Eating, Active Play, Parent EducationIn 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. | Behavioural | Healthy Eating, Active Play, Parent Education |
| Healthy Eating + Active PlayIn 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. | Behavioural | Healthy Eating + Active Play |
| Healthy Eating, Self-Regulation, Parent EducationIn 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. | Behavioural | Healthy Eating, Self-Regulation, Parent Education |
| Healthy Eating + Self-RegulationIn 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. | Behavioural | Healthy Eating + Self-Regulation |
| Healthy Eating + Parent EducationIn 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. | Behavioural | Healthy Eating + Parent Education |
| Healthy Eating OnlyIn 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. | Behavioural | Healthy Eating Only |
| Active Play, Self-Regulation, Parent EducationIn 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. | Behavioural | Active Play, Self-Regulation, Parent Education |
| Active Play + Self-RegulationIn 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. | Behavioural | Active Play + Self-Regulation |
| Active Play + Parent EducationIn 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. | Behavioural | Active Play + Parent Education |
| Active Play OnlyIn 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. | Behavioural | Active Play Only |
| Self-Regulation + Parent EducationIn 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. | Behavioural | Self-Regulation + Parent Education |
| Self-Regulation OnlyIn 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. | Behavioural | Self-Regulation Only |
| Food Literacy + Parent EducationChildren 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. | Behavioural | Food Literacy + Parent Education |
| Food Literacy OnlyChildren 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. | Behavioural | Food Literacy Only |
Primary outcome
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
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
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
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.
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
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
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
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.
3 secondary outcomes
Children's Appetitive Behaviors
Time frame: Baseline, Post-Intervention (5-6 months)
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
Time frame: Baseline, Post-Intervention (5-6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- A child health and wellness research study funded by the U.S. Department of Agriculture (USDA)Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Francis, Ph.D. principal investigator
The Pennsylvania State University
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating, Active Play, Self-Regulation, Parent Education, Healthy Eating, Active Play, Self-Regulation and Healthy Eating, Active Play, Parent Education in people with Obesity, Childhood, run by Penn State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Body Mass Index (BMI) (time frame: Change from baseline to post-assessment (5-6months) and follow-up (~9 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.