Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger (CTSI)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curriculum Testing
Sponsored by
About this trial
This is an interventional health services research trial for Pediatric Obesity focused on measuring hunger and fullness, regulation of energy intake, energy compensation, nutrition knowledge
Eligibility Criteria
Inclusion Criteria:
- Children must be between the ages of 4-5 years-old at the time they participate in the study.
- All children will be physically healthy, with no food allergies. Parents are asked if the child has any medical problems or is taking any prescription medication. If the answer to either of these questions is yes but the medical problem (or medication) is not severe nor has the potential to affect the study outcome, as judged by our PI, then the child may be included.
- The person primarily responsible for feeding the child must be able to make nine, two-hour visits along with the child to the lab within an nine-week time period.
Exclusion Criteria:
- Child is younger than 4 or older than 6.
- Child is not physically healthy. Parents are asked if the child has any medical problems or is taking any prescription medication. If the medical problem (or medication) is severe or may affect the study outcome, as judged by our PI, then the child may be excluded.
- Child has food allergies.
- Person primarily responsible for feeding child and child cannot make nine, 90 minute - 2 hour visits along with the child within a 9-week period.
Sites / Locations
- The Pennsylvania State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Curriculum Testing
Arm Description
Test an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals.
Outcomes
Primary Outcome Measures
Energy Compensation measured by compensation score.
Children's ability to compensate for calories in a first course will be assessed by measurement of compensation score. The Compensation Score will be measured over two baseline lab sessions where children are served a low-energy drink (~3 calories) or a high-energy drink (150 calories), followed 25-30 minutes later by a buffet test-meal consisting of the common foods listed above.
Eating in the Absence of Hunger after a buffet meal: Food Intake weighed in grams and calories.
Children's intake (grams and calories) of tasty snacks when not hungry (eating in the absence of hunger). This measurement is taken after a buffet meal is served.
Energy intake at a buffet meal
Measured at an objective laboratory test meal (kcal and grams)
Nutrition knowledge test for children
Age appropriate nutrition questions, with questions such as: 1) What body parts are involved with digestion? 2) Why do we eat? 3) Why do we stop eating? 4) What happens when we eat too much? and 5) Simulation of eating just the right amount using a computer game.
Secondary Outcome Measures
Liking of foods
Ratings of how much a child likes specific foods used in the study test meals, completed on visual analog scales.
Wanting of foods
Ratings of how much a child wants to eat specific foods used in the study test meals, completed on visual analog scales.
Fullness feelings
Ratings of how full the child feels on a child friendly visual analog scale.
Height
Height in m measured by a stadiometer.
Weight
Weight in kg by standard digital scale.
Body mass index
Calculated from height and weight (kg/m^2)
BMI percentile
Calculated from height, weight, age, sex
BMI z-score
Calculated from height, weight, age, sex
Child Eating Behavior Questionnaire
Parent-reported questionnaire of habitual eating styles in children.
Pubertal development Questionnaire
Parent-reported questionnaire
Family demographics
Parent-reported questionnaire
Child feeding Questionnaire
Parent-reported questionnaire of feeding strategies.
Infant Feeding Questionnaire
Parent-reported questionnaire of infant feeding.
Child Behavior
Parent-reported questionnaire of child behavior.
Parent Eating Competence
Parent-reported questionnaire of parent eating competence.
Division of Responsibility in Child Feeding Questionnaire
Parent-reported questionnaire of division of responsibility in child feeding
Nutrition Steps Questionnaire
Standardized nutrition questionnaire.
Caregiver Feeding Style Questionnaire
Parent-reported questionnaire of caregiver feeding style
Full Information
NCT ID
NCT03064919
First Posted
February 1, 2017
Last Updated
January 7, 2021
Sponsor
Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT03064919
Brief Title
Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger
Acronym
CTSI
Official Title
Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger and Fullness
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2015 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this multi-year project is to develop an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals. There are currently no validated methods for teaching children these basic skills, despite the fact that doing so is necessary to prevent the development of obesity.
Detailed Description
The purpose of this multi-year project is to develop an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals. There are currently no validated methods for teaching children these basic skills, despite the fact that doing so is necessary to prevent the development of obesity. To accomplish this task, the investigators have assembled a multi-disciplinary team from nutrition, eating behavior, obesity prevention, science education, and information sciences and technology.
First, the investigators will refine and build upon a pre-existing curriculum by incorporating 1) state-of-the art theories in early childhood science education, 2) innovative virtual technology to provide more realistic simulations of hunger and fullness, and 3) a parent training component to improve long-range sustainability.
Second, the investigators will conduct an experimental study to determine the effectiveness of this curriculum on children's ability to regulate energy intake in the laboratory. Forty children (ages 4-5) will be tested over an 9-week period. Key outcomes will be children's adjustment in intake in response to a first course (energy compensation) and children's intake of tasty snacks when not hungry (eating in the absence of hunger). Additionally, the investigators will measure other variables likely to impact the success of the curriculum, for example: child gender/age, parent feeding practices, parent education, infant feeding practices, child/parent weight status, and others.
The long term goal of this line of research will be to create an evidence based curriculum that can be integrated into early childhood education and health-based interventions. The translation potential of this research is broad because once validated, the curriculum can be disseminated more widely to early childhood education programs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
hunger and fullness, regulation of energy intake, energy compensation, nutrition knowledge
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals will be developed. The investigators will then conduct an experimental study to determine the effectiveness of this curriculum on children's ability to regulate energy intake in the laboratory. Key outcomes will be children's adjustment in intake in response to a first course (energy compensation) and children's intake of tasty snacks when not hungry (eating in the absence of hunger). Data describing variables likely to impact the success of the curriculum will be collected, for example: child gender/age, parent feeding practices, parent education, infant feeding practices, child/parent weight status, and others.
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curriculum Testing
Arm Type
Experimental
Arm Description
Test an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals.
Intervention Type
Behavioral
Intervention Name(s)
Curriculum Testing
Intervention Description
An evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals was developed by refining an existing curriculum. State-of-the art theories in early childhood science education, innovative virtual technology to provide more realistic simulations of hunger and fullness, and a parent training component to improve long-range sustainability were incorporated. This 9-wk intervention will be tested by forty children (ages 4-5). Key outcomes will be children's adjustment in intake in response to a first course (energy compensation) and children's intake of tasty snacks when not hungry (eating in the absence of hunger). Additionally, the investigators will measure other variables likely to impact the success of the curriculum, for example: child gender/age, parent feeding practices, parent education, infant feeding practices, child/parent weight status, and others.
Primary Outcome Measure Information:
Title
Energy Compensation measured by compensation score.
Description
Children's ability to compensate for calories in a first course will be assessed by measurement of compensation score. The Compensation Score will be measured over two baseline lab sessions where children are served a low-energy drink (~3 calories) or a high-energy drink (150 calories), followed 25-30 minutes later by a buffet test-meal consisting of the common foods listed above.
Time Frame
Change from baseline to 9 weeks later.
Title
Eating in the Absence of Hunger after a buffet meal: Food Intake weighed in grams and calories.
Description
Children's intake (grams and calories) of tasty snacks when not hungry (eating in the absence of hunger). This measurement is taken after a buffet meal is served.
Time Frame
Change from baseline to 9 weeks later.
Title
Energy intake at a buffet meal
Description
Measured at an objective laboratory test meal (kcal and grams)
Time Frame
Change from baseline to 9 weeks later
Title
Nutrition knowledge test for children
Description
Age appropriate nutrition questions, with questions such as: 1) What body parts are involved with digestion? 2) Why do we eat? 3) Why do we stop eating? 4) What happens when we eat too much? and 5) Simulation of eating just the right amount using a computer game.
Time Frame
Change from baseline to 9 weeks later
Secondary Outcome Measure Information:
Title
Liking of foods
Description
Ratings of how much a child likes specific foods used in the study test meals, completed on visual analog scales.
Time Frame
Baseline and 9 weeks later.
Title
Wanting of foods
Description
Ratings of how much a child wants to eat specific foods used in the study test meals, completed on visual analog scales.
Time Frame
Baseline and 9 weeks later.
Title
Fullness feelings
Description
Ratings of how full the child feels on a child friendly visual analog scale.
Time Frame
Baseline and 9 weeks later.
Title
Height
Description
Height in m measured by a stadiometer.
Time Frame
Baseline and 9 weeks later.
Title
Weight
Description
Weight in kg by standard digital scale.
Time Frame
Baseline and 9 weeks later.
Title
Body mass index
Description
Calculated from height and weight (kg/m^2)
Time Frame
Baseline and 9 weeks later.
Title
BMI percentile
Description
Calculated from height, weight, age, sex
Time Frame
Baseline and 9 weeks later.
Title
BMI z-score
Description
Calculated from height, weight, age, sex
Time Frame
Baseline and 9 weeks later.
Title
Child Eating Behavior Questionnaire
Description
Parent-reported questionnaire of habitual eating styles in children.
Time Frame
Baseline and 9 weeks later.
Title
Pubertal development Questionnaire
Description
Parent-reported questionnaire
Time Frame
Baseline
Title
Family demographics
Description
Parent-reported questionnaire
Time Frame
Baseline
Title
Child feeding Questionnaire
Description
Parent-reported questionnaire of feeding strategies.
Time Frame
Baseline and 9 weeks later.
Title
Infant Feeding Questionnaire
Description
Parent-reported questionnaire of infant feeding.
Time Frame
Baseline and 9 weeks later.
Title
Child Behavior
Description
Parent-reported questionnaire of child behavior.
Time Frame
Baseline and 9 weeks later.
Title
Parent Eating Competence
Description
Parent-reported questionnaire of parent eating competence.
Time Frame
Baseline and 9 weeks later.
Title
Division of Responsibility in Child Feeding Questionnaire
Description
Parent-reported questionnaire of division of responsibility in child feeding
Time Frame
Baseline and 9 weeks later.
Title
Nutrition Steps Questionnaire
Description
Standardized nutrition questionnaire.
Time Frame
Baseline and 9 weeks later.
Title
Caregiver Feeding Style Questionnaire
Description
Parent-reported questionnaire of caregiver feeding style
Time Frame
Baseline and 9 weeks later.
Other Pre-specified Outcome Measures:
Title
Child Age
Description
Child age in months.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children must be between the ages of 4-5 years-old at the time they participate in the study.
All children will be physically healthy, with no food allergies. Parents are asked if the child has any medical problems or is taking any prescription medication. If the answer to either of these questions is yes but the medical problem (or medication) is not severe nor has the potential to affect the study outcome, as judged by our PI, then the child may be included.
The person primarily responsible for feeding the child must be able to make nine, two-hour visits along with the child to the lab within an nine-week time period.
Exclusion Criteria:
Child is younger than 4 or older than 6.
Child is not physically healthy. Parents are asked if the child has any medical problems or is taking any prescription medication. If the medical problem (or medication) is severe or may affect the study outcome, as judged by our PI, then the child may be excluded.
Child has food allergies.
Person primarily responsible for feeding child and child cannot make nine, 90 minute - 2 hour visits along with the child within a 9-week period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen L Keller, Ph.D.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger
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