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Completed

NCT Number: NCT03064919

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

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.

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Key information

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

Secondary outcomes

  1. Liking of foods

    Time frame: Baseline and 9 weeks later.

    Ratings of how much a child likes specific foods used in the study test meals, completed on visual analog scales.

  2. Wanting of foods

    Time frame: Baseline and 9 weeks later.

    Ratings of how much a child wants to eat specific foods used in the study test meals, completed on visual analog scales.

  3. Fullness feelings

    Time frame: Baseline and 9 weeks later.

    Ratings of how full the child feels on a child friendly visual analog scale.

  4. Height

    Time frame: Baseline and 9 weeks later.

    Height in m measured by a stadiometer.

  5. Weight

    Time frame: Baseline and 9 weeks later.

    Weight in kg by standard digital scale.

  6. Body mass index

    Time frame: Baseline and 9 weeks later.

    Calculated from height and weight (kg/m^2)

  7. BMI percentile

    Time frame: Baseline and 9 weeks later.

    Calculated from height, weight, age, sex

  8. BMI z-score

    Time frame: Baseline and 9 weeks later.

    Calculated from height, weight, age, sex

  9. Child Eating Behavior Questionnaire

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of habitual eating styles in children.

  10. Pubertal development Questionnaire

    Time frame: Baseline

    Parent-reported questionnaire

  11. Family demographics

    Time frame: Baseline

    Parent-reported questionnaire

  12. Child feeding Questionnaire

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of feeding strategies.

  13. Infant Feeding Questionnaire

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of infant feeding.

  14. Child Behavior

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of child behavior.

  15. Parent Eating Competence

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of parent eating competence.

  16. Division of Responsibility in Child Feeding Questionnaire

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of division of responsibility in child feeding

  17. Nutrition Steps Questionnaire

    Time frame: Baseline and 9 weeks later.

    Standardized nutrition questionnaire.

  18. Caregiver Feeding Style Questionnaire

    Time frame: Baseline and 9 weeks later.

    Parent-reported questionnaire of caregiver feeding style

Other outcomes

  1. Child Age

    Time frame: Baseline

    Child age in months.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Acronym: CTSI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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