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Clinical Trials/NCT03064919
NCT03064919CompletedNot Applicable

Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger and Fullness

Penn State University2 sites in 1 country64 target enrollmentStarted: June 25, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
2
Primary Endpoint
Eating in the Absence of Hunger after a buffet meal: Food Intake weighed in grams and calories.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
4 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • 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.

Outcomes

Primary Outcomes

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.

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.

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.

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)

Secondary Outcomes

  • Liking of foods(Baseline and 9 weeks later.)
  • Wanting of foods(Baseline and 9 weeks later.)
  • BMI percentile(Baseline and 9 weeks later.)
  • Pubertal development Questionnaire(Baseline)
  • Family demographics(Baseline)
  • Child feeding Questionnaire(Baseline and 9 weeks later.)
  • Child Behavior(Baseline and 9 weeks later.)
  • Division of Responsibility in Child Feeding Questionnaire(Baseline and 9 weeks later.)
  • Caregiver Feeding Style Questionnaire(Baseline and 9 weeks later.)
  • Fullness feelings(Baseline and 9 weeks later.)
  • Height(Baseline and 9 weeks later.)
  • Weight(Baseline and 9 weeks later.)
  • Infant Feeding Questionnaire(Baseline and 9 weeks later.)
  • Body mass index(Baseline and 9 weeks later.)
  • BMI z-score(Baseline and 9 weeks later.)
  • Child Eating Behavior Questionnaire(Baseline and 9 weeks later.)
  • Parent Eating Competence(Baseline and 9 weeks later.)
  • Nutrition Steps Questionnaire(Baseline and 9 weeks later.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kathleen Loralee Keller

Director

Penn State University

Study Sites (2)

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