Clinical trial NCT02229552: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity in Children
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 237
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children completed measurements of body weight, habituation to food, questionnaires and cognitive assessments in a repeated assessment prospective study.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in zBMI
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Leonard Epstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.