Pediatric ObesityCTSINCT03064919
Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger
A study testing Curriculum Testing in people with Pediatric Obesity, run by Penn State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Curriculum Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2015to 2 Nov 2018
- 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 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger and Fullness
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Curriculum Testing
- Keywords
- hunger and fullness, regulation of energy intake, energy compensation, nutrition knowledge
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curriculum TestingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Curriculum Testing | Experimental | Test an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals. Receives: Behavioral: Curriculum Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 9 weeks later.
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.
Measured: Change from baseline to 9 weeks later.
Energy intake at a buffet meal
Measured at an objective laboratory test meal (kcal and grams)
Measured: Change from baseline to 9 weeks later
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.
Measured: Change from baseline to 9 weeks later
Secondary outcomes (18)
Liking of foods
Ratings of how much a child likes specific foods used in the study test meals, completed on visual analog scales.
Measured: Baseline and 9 weeks later.
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.
Measured: Baseline and 9 weeks later.
Fullness feelings
Ratings of how full the child feels on a child friendly visual analog scale.
Measured: Baseline and 9 weeks later.
Height
Height in m measured by a stadiometer.
Measured: Baseline and 9 weeks later.
Weight
Weight in kg by standard digital scale.
Measured: Baseline and 9 weeks later.
Body mass index
Calculated from height and weight (kg/m^2)
Measured: Baseline and 9 weeks later.
BMI percentile
Calculated from height, weight, age, sex
Measured: Baseline and 9 weeks later.
BMI z-score
Calculated from height, weight, age, sex
Measured: Baseline and 9 weeks later.
Child Eating Behavior Questionnaire
Parent-reported questionnaire of habitual eating styles in children.
Measured: Baseline and 9 weeks later.
Pubertal development Questionnaire
Parent-reported questionnaire
Measured: Baseline
Family demographics
Parent-reported questionnaire
Measured: Baseline
Child feeding Questionnaire
Parent-reported questionnaire of feeding strategies.
Measured: Baseline and 9 weeks later.
Infant Feeding Questionnaire
Parent-reported questionnaire of infant feeding.
Measured: Baseline and 9 weeks later.
Child Behavior
Parent-reported questionnaire of child behavior.
Measured: Baseline and 9 weeks later.
Parent Eating Competence
Parent-reported questionnaire of parent eating competence.
Measured: Baseline and 9 weeks later.
Division of Responsibility in Child Feeding Questionnaire
Parent-reported questionnaire of division of responsibility in child feeding
Measured: Baseline and 9 weeks later.
Nutrition Steps Questionnaire
Standardized nutrition questionnaire.
Measured: Baseline and 9 weeks later.
Caregiver Feeding Style Questionnaire
Parent-reported questionnaire of caregiver feeding style
Measured: Baseline and 9 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start25 Jun 2015
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
- Investigators
- Kathleen L Keller, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064919
- Sponsor's protocol ID
- Hunger and Fullness
- Acronym
- CTSI
- Status last verified
- Jan 2021
- First submitted
- 1 Feb 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger and Fullness
- ClinicalTrials.gov ID
- NCT03064919
- Acronym / sponsor ID
- CTSI / Hunger and Fullness
- Conditions
- Pediatric Obesity
- Keywords
- hunger and fullness, regulation of energy intake, energy compensation, nutrition knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 27 Feb 2017 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Curriculum Testing | Experimental | Behavioral: Curriculum TestingTest an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Curriculum TestingAn 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. | Behavioural | Curriculum Testing |
Primary outcome
Energy Compensation measured by compensation score.
Time frame: Change from baseline to 9 weeks later.
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.
Time frame: Change from baseline to 9 weeks later.
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
Time frame: Change from baseline to 9 weeks later
Measured at an objective laboratory test meal (kcal and grams)
Nutrition knowledge test for children
Time frame: Change from baseline to 9 weeks later
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.
18 secondary outcomes
Liking of foods
Time frame: Baseline and 9 weeks later.
Wanting of foods
Time frame: Baseline and 9 weeks later.
Fullness feelings
Time frame: Baseline and 9 weeks later.
Height
Time frame: Baseline and 9 weeks later.
Weight
Time frame: Baseline and 9 weeks later.
Body mass index
Time frame: Baseline and 9 weeks later.
BMI percentile
Time frame: Baseline and 9 weeks later.
BMI z-score
Time frame: Baseline and 9 weeks later.
Child Eating Behavior Questionnaire
Time frame: Baseline and 9 weeks later.
Pubertal development Questionnaire
Time frame: Baseline
Family demographics
Time frame: Baseline
Child feeding Questionnaire
Time frame: Baseline and 9 weeks later.
Infant Feeding Questionnaire
Time frame: Baseline and 9 weeks later.
Child Behavior
Time frame: Baseline and 9 weeks later.
Parent Eating Competence
Time frame: Baseline and 9 weeks later.
Division of Responsibility in Child Feeding Questionnaire
Time frame: Baseline and 9 weeks later.
Nutrition Steps Questionnaire
Time frame: Baseline and 9 weeks later.
Caregiver Feeding Style Questionnaire
Time frame: Baseline and 9 weeks later.
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 11 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Kathleen L Keller, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curriculum Testing in people with Pediatric Obesity, run by Penn State University at 1 site in United States.
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 3 inclusion and 4 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Energy Compensation measured by compensation score. (time frame: Change from baseline to 9 weeks later.). The study lists 4 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 11 Jan 2021.