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

Pediatric Obesity Clinical Trial

— CTSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064919
• Other study ID #: Hunger and Fullness
• Status: Completed
• Phase: N/A
• Start date: June 25, 2015
• Est. completion date: November 2, 2018

Study information

• Verified date: January 2021
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 development of obesity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Age	Child age in months.	Baseline
Primary	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.
Primary	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.
Primary	Energy intake at a buffet meal	Measured at an objective laboratory test meal (kcal and grams)	Change from baseline to 9 weeks later
Primary	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	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.
Secondary	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.
Secondary	Fullness feelings	Ratings of how full the child feels on a child friendly visual analog scale.	Baseline and 9 weeks later.
Secondary	Height	Height in m measured by a stadiometer.	Baseline and 9 weeks later.
Secondary	Weight	Weight in kg by standard digital scale.	Baseline and 9 weeks later.
Secondary	Body mass index	Calculated from height and weight (kg/m^2)	Baseline and 9 weeks later.
Secondary	BMI percentile	Calculated from height, weight, age, sex	Baseline and 9 weeks later.
Secondary	BMI z-score	Calculated from height, weight, age, sex	Baseline and 9 weeks later.
Secondary	Child Eating Behavior Questionnaire	Parent-reported questionnaire of habitual eating styles in children.	Baseline and 9 weeks later.
Secondary	Pubertal development Questionnaire	Parent-reported questionnaire	Baseline
Secondary	Family demographics	Parent-reported questionnaire	Baseline
Secondary	Child feeding Questionnaire	Parent-reported questionnaire of feeding strategies.	Baseline and 9 weeks later.
Secondary	Infant Feeding Questionnaire	Parent-reported questionnaire of infant feeding.	Baseline and 9 weeks later.
Secondary	Child Behavior	Parent-reported questionnaire of child behavior.	Baseline and 9 weeks later.
Secondary	Parent Eating Competence	Parent-reported questionnaire of parent eating competence.	Baseline and 9 weeks later.
Secondary	Division of Responsibility in Child Feeding Questionnaire	Parent-reported questionnaire of division of responsibility in child feeding	Baseline and 9 weeks later.
Secondary	Nutrition Steps Questionnaire	Standardized nutrition questionnaire.	Baseline and 9 weeks later.
Secondary	Caregiver Feeding Style Questionnaire	Parent-reported questionnaire of caregiver feeding style	Baseline and 9 weeks later.