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

NCT03064919 | Completed

• 1 other identifier: Hunger and Fullness
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

hunger and fullness; regulation of energy intake; energy compensation; nutrition knowledge

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (18)

• Liking of foods

  Baseline and 9 weeks later.

• Wanting of foods

  Baseline and 9 weeks later.

• Fullness feelings

  Baseline and 9 weeks later.

• Height

  Baseline and 9 weeks later.

• Weight

  Baseline and 9 weeks later.

Other Outcomes (1)

• Child Age

  Baseline

Study Arms (1)

Curriculum Testing

EXPERIMENTAL

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

Behavioral: Curriculum Testing

Interventions

Curriculum Testing BEHAVIORAL

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.

Curriculum Testing

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen L Keller, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 27, 2017
• Study Start: June 25, 2015
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)