Habituation to Food as a Risk Factor for Pediatric Obesity

Study Overview
=================
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.

Official Title
-----------------
Habituation to Food as a Risk Factor for Pediatric Obesity

Conditions
-----------------
Obesity in Children

Intervention / Treatment
-----------------
* Other: Standardized Assessments


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years |