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Habituation to Food as a Risk Factor for Pediatric Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229552
Recruitment Status : Unknown
Verified November 2015 by State University of New York at Buffalo.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2014
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo

Brief Summary:
The study is designed to assess habituation of behavioral responding for food as risk factors for increases in Standardized Body Mass Index (zBMI) over three years in non-overweight children.

Condition or disease
Obesity in Children

Detailed Description:
Cross sectional data have shown slower habituation is related to greater energy intake, and habituation is slower for overweight/obese compared to leaner youth, but it is not known whether this is a result of being overweight, or whether slower habituation is a risk factor for weight gain. The goal of this application is to study individual differences in behavioral (responding for food) habituation as risk factors for alterations in zBMI and body fat over a two year period in 200, 8 to 12 year-old non-overweight children. This project will provide the first test of the hypothesis that slow habituation to food is a risk factor for increases in zBMI in non-overweight youth.

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Study Type : Observational
Actual Enrollment : 231 participants
Time Perspective: Cross-Sectional
Official Title: Habituation to Food as a Risk Factor for Pediatric Obesity
Study Start Date : November 2012
Estimated Primary Completion Date : June 2016



Primary Outcome Measures :
  1. change in zBMI [ Time Frame: 2 years ]
    To assess the rate of habituation of behavioral responding to savory, sweet and salty foods as independent or interactive risk factors for zBMI trajectories, with the hypothesis that the rate of habituation of behavioral responding for food predicts zBMI trajectories over time, controlling for child gender, parental education, parental BMI, physical activity, ethnicity, the reinforcing value of food and eating in the absence of hunger.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Two hundred and thirty healthy non-overweight children between the ages of 8-12 will be studied.
Criteria

Inclusion Criteria:

  • 8-12 years of age
  • Participants will include children who are at the 50th BMI percentile and less than the 85th BMI percentile (BMI = kg/m2) at baseline. We will also include children who are below the 50th percentile, but have at least one biological parent with a current BMI ≥ 25 kg/m2.

Exclusion Criteria:

  • Food allergies or special diets: Youth should have no dietary restrictions that could interfere with these experiments, including food allergies or religious or ethnic practices that limit food choice or medical conditions which alter nutritional status or intestinal absorption (e.g. inflammatory bowel disease).
  • Activity restrictions: Children who have activity restrictions due to medical or physical problems, such as uncontrolled exercise induced asthma or a disability requiring wheelchair use will not participate.
  • Psychopathology, medications or sickness: Children should have no psychopathology (e.g. childhood schizophrenia) or developmental disabilities that would limit participation. Children will also be excluded if they are taking medications that could affect their level of activity or appetite (e.g. methylphenidate).
  • Moderate or greater liking of study foods. Children must report at least a moderate liking ( 3 or greater on a 5-point Likert-type scale) of the foods used in these studies and be willing to consume them.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229552


Locations
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United States, New York
University at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Leonard Epstein, Ph.D. University at Buffalo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02229552    
Other Study ID Numbers: 1102924-1-61250
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms