Developing Novel Methods to Teach Children to Recognize Internal Signals of Hunger (CTSI)

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Curriculum Testing

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Curriculum Testing; Test an evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals.

Behavioral: Curriculum Testing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from baseline to 9 weeks later.
Energy intake at a buffet meal	Measured at an objective laboratory test meal (kcal and grams)	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.	Change from baseline to 9 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liking of foods	Ratings of how much a child likes specific foods used in the study test meals, completed on visual analog scales.	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.	Baseline and 9 weeks later.
Fullness feelings	Ratings of how full the child feels on a child friendly visual analog scale.	Baseline and 9 weeks later.
Height	Height in m measured by a stadiometer.	Baseline and 9 weeks later.
Weight	Weight in kg by standard digital scale.	Baseline and 9 weeks later.
Body mass index	Calculated from height and weight (kg/m^2)	Baseline and 9 weeks later.
BMI percentile	Calculated from height, weight, age, sex	Baseline and 9 weeks later.
BMI z-score	Calculated from height, weight, age, sex	Baseline and 9 weeks later.
Child Eating Behavior Questionnaire	Parent-reported questionnaire of habitual eating styles in children.	Baseline and 9 weeks later.
Pubertal development Questionnaire	Parent-reported questionnaire	Baseline
Family demographics	Parent-reported questionnaire	Baseline
Child feeding Questionnaire	Parent-reported questionnaire of feeding strategies.	Baseline and 9 weeks later.
Infant Feeding Questionnaire	Parent-reported questionnaire of infant feeding.	Baseline and 9 weeks later.
Child Behavior	Parent-reported questionnaire of child behavior.	Baseline and 9 weeks later.
Parent Eating Competence	Parent-reported questionnaire of parent eating competence.	Baseline and 9 weeks later.
Division of Responsibility in Child Feeding Questionnaire	Parent-reported questionnaire of division of responsibility in child feeding	Baseline and 9 weeks later.
Nutrition Steps Questionnaire	Standardized nutrition questionnaire.	Baseline and 9 weeks later.
Caregiver Feeding Style Questionnaire	Parent-reported questionnaire of caregiver feeding style	Baseline and 9 weeks later.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Age	Child age in months.	Baseline

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2015
• Primary Completion (Actual): November 2, 2018
• Study Completion (Actual): November 2, 2018

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: nutrition knowledge; energy compensation; hunger and fullness; regulation of energy intake
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Hunger and Fullness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No