Clinical trial NCT01208870: Translating Habituation Research to Interventions for Pediatric Obesity
Official title: Translating Habituation Research to Interventions for Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Habituation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-09-24
Enrollment: 94
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

Detailed description: Habituation is one factor that may be related to excess energy intake. Research has shown that the rate of habituation is inversely related to the amount of food consumed and slower habituation may be a factor that is relevant to obesity, as overweight youth and adults habituate slower and consume more energy than their peers. Habituation is a basic form of learning that is observed in many response systems. We believe that habituation is an important process that mediates food regulation during a meal and across meals. However, there has been no research in children that translates basic research on habituation to food into clinical interventions for pediatric obesity. In the first phase, we will implement a series of laboratory studies to assess the effects of stimulus specificity and variety and the simultaneous reduction of variety for high energy density foods on short (within meal) and long-term (across meal) habituation. The second phase is designed to implement a series of field studies that will extend basic research from the first phase as well as define the optimal interval for reducing variety to facilitate long-term habituation to high energy density foods in the natural environment. The third phase is designed to develop and pilot test a family-based behavioral intervention for children that incorporates findings from phase2 into a clinical intervention.

Eligibility criteria: Inclusion Criteria:

* Children ages 8-12 years of age
* At or above 85th BMI percentile
* Children must eat almost all meals with the exception of school lunch with the family.
* Overweight parent

Exclusion Criteria:

* Children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods.
* Families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders.
* The parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes.
* Children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.

Primary outcomes:
measure: Change of Child Body Composition
timeFrame: Baseline to 6 months
measure: Change Parent Body Composition
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Dietary Intake of Calories
timeFrame: Baseline to 6 months
measure: Change in Parent Delay Discounting
timeFrame: Baseline to 6 months
measure: Change in Child Delay Discounting
timeFrame: Baseline to 6 months
measure: Changes in Variety Measures
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Leonard H. Epstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein LH, Kilanowski C, Paluch RA, Raynor H, Daniel TO. Reducing variety enhances effectiveness of family-based treatment for pediatric obesity. Eat Behav. 2015 Apr;17:140-3. doi: 10.1016/j.eatbeh.2015.02.001. Epub 2015 Feb 13.
citation: Epstein LH, Fletcher KD, O'Neill J, Roemmich JN, Raynor H, Bouton ME. Food characteristics, long-term habituation and energy intake. Laboratory and field studies. Appetite. 2013 Jan;60(1):40-50. doi: 10.1016/j.appet.2012.08.030. Epub 2012 Oct 22.
citation: Epstein LH, Carr KA, Cavanaugh MD, Paluch RA, Bouton ME. Long-term habituation to food in obese and nonobese women. Am J Clin Nutr. 2011 Aug;94(2):371-6. doi: 10.3945/ajcn.110.009035. Epub 2011 May 18.