Habituation to Food as a Risk Factor for Pediatric Obesity

Obesity in Children Clinical Trial

Official title:

Habituation to Food as a Risk Factor for Pediatric Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229552
• Other study ID #: 1102924-1-61250
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: October 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity in Children
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   UB Division of Behavioral Medicine Website