Habituation to Food as a Risk Factor for Pediatric Obesity

October 1, 2020 updated by: Leonard Epstein, State University of New York at Buffalo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Baseline Cohort
Children completed body weight and other measures at baseline, 1-year follow up and 2-year follow up measurement periods.
Other: Standardized Assessments
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Leonard Epstein, Ph.D., University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1102924-1-61250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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