Clinical trial NCT03064919: Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger
Official title: Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger and Fullness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: hunger and fullness
regulation of energy intake
energy compensation
nutrition knowledge
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Energy Compensation measured by compensation score.
timeFrame: Change from baseline to 9 weeks later.
measure: Eating in the Absence of Hunger after a buffet meal: Food Intake weighed in grams and calories.
timeFrame: Change from baseline to 9 weeks later.
measure: Energy intake at a buffet meal
timeFrame: Change from baseline to 9 weeks later
measure: Nutrition knowledge test for children
timeFrame: Change from baseline to 9 weeks later
Secondary outcomes:
measure: Liking of foods
timeFrame: Baseline and 9 weeks later.
measure: Wanting of foods
timeFrame: Baseline and 9 weeks later.
measure: Fullness feelings
timeFrame: Baseline and 9 weeks later.
measure: Height
timeFrame: Baseline and 9 weeks later.
measure: Weight
timeFrame: Baseline and 9 weeks later.
measure: Body mass index
timeFrame: Baseline and 9 weeks later.
measure: BMI percentile
timeFrame: Baseline and 9 weeks later.
measure: BMI z-score
timeFrame: Baseline and 9 weeks later.
measure: Child Eating Behavior Questionnaire
timeFrame: Baseline and 9 weeks later.
measure: Pubertal development Questionnaire
timeFrame: Baseline
measure: Family demographics
timeFrame: Baseline
measure: Child feeding Questionnaire
timeFrame: Baseline and 9 weeks later.
measure: Infant Feeding Questionnaire
timeFrame: Baseline and 9 weeks later.
measure: Child Behavior
timeFrame: Baseline and 9 weeks later.
measure: Parent Eating Competence
timeFrame: Baseline and 9 weeks later.
measure: Division of Responsibility in Child Feeding Questionnaire
timeFrame: Baseline and 9 weeks later.
measure: Nutrition Steps Questionnaire
timeFrame: Baseline and 9 weeks later.
measure: Caregiver Feeding Style Questionnaire
timeFrame: Baseline and 9 weeks later.
Other outcomes:
measure: Child Age
timeFrame: Baseline
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Kathleen L Keller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: