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Habituation to Food as a Risk Factor for Pediatric Obesity

Primary Purpose

Obesity in Children

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standardized Assessments

About this trial

This is an interventional basic science trial for Obesity in Children

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University at Buffalo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Baseline Cohort

Arm Description

Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.

Outcomes

Primary Outcome Measures

Change in zBMI

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02229552

First Posted

July 18, 2014

Last Updated

October 1, 2020

Sponsor

State University of New York at Buffalo

1. Study Identification

Unique Protocol Identification Number

NCT02229552

Brief Title

Habituation to Food as a Risk Factor for Pediatric Obesity

Official Title

Habituation to Food as a Risk Factor for Pediatric Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

State University of New York at Buffalo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 two years in non-overweight 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity in Children

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

237 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baseline Cohort

Arm Type

Other

Arm Description

Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.

Intervention Type

Other

Intervention Name(s)

Standardized Assessments

Intervention Description

Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.

Primary Outcome Measure Information:

Title

Change in zBMI

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonard Epstein, Ph.D.

Organizational Affiliation

University at Buffalo

Official's Role

Principal Investigator

Facility Information:

Facility Name

University at Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14214

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32799072

Citation

Epstein LH, Carr KA, O'Brien A, Paluch RA, Temple JL. High reinforcing value of food is related to slow habituation to food. Eat Behav. 2020 Aug;38:101414. doi: 10.1016/j.eatbeh.2020.101414. Epub 2020 Jul 29.

Results Reference

derived

PubMed Identifier

25891040

Citation

Epstein LH, Carr KA, Scheid JL, Gebre E, O'Brien A, Paluch RA, Temple JL. Taste and food reinforcement in non-overweight youth. Appetite. 2015 Aug;91:226-32. doi: 10.1016/j.appet.2015.04.050. Epub 2015 Apr 16.

Results Reference

derived

PubMed Identifier

25733636

Citation

Kong KL, Feda DM, Eiden RD, Epstein LH. Origins of food reinforcement in infants. Am J Clin Nutr. 2015 Mar;101(3):515-22. doi: 10.3945/ajcn.114.093237. Epub 2015 Jan 14.

Results Reference

derived

Links:

URL

http://medicine.buffalo.edu/departments/pediatrics/divisions/behavioral-medicine.html

Description

UB Division of Behavioral Medicine Website

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Habituation to Food as a Risk Factor for Pediatric Obesity

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