Translating Habituation Research to Interventions for Pediatric Obesity (EAT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pediatric Obesity Habituation Family-based Behavioral Interventions |
Behavioral: Habituation theory and Pediatric Obesity |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Translating Habituation Research to Interventions for Pediatric Obesity |
- Habituation [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]In phase 1 and phase 2, the primary outcome measure will be responding for food on the habituation task. During phase 3, the primary outcome measure will be reductions in z-BMI.
- Dietary Intake [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]During all phases the secondary outcome is changes in energy intake.
| Estimated Enrollment: | 281 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Group
Traditional family based weight control program with components from habituation theory incorporated into the treatment.
|
Behavioral: Habituation theory and Pediatric Obesity
The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group.
|
|
Active Comparator: Nutrition Education Control
Traditional family based weight control program, without components of habituation theory incorporated.
|
Behavioral: Habituation theory and Pediatric Obesity
The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group.
|
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| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
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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 perclude them from making the requistite 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.
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Contacts and Locations| Contact: Kelly K Dearing, MPH | 716-829-6817 | kdearing@buffalo.edu |
| Contact: Leonard H Epstein, Ph.D. | 716-829-3400 | lhenet@acsu.buffalo.edu |
| United States, New York | |
| University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine | Recruiting |
| Buffalo, New York, United States, 14214 | |
| Principal Investigator: Leonard H Epstein, Ph.D. | |
More Information
No publications provided by State University of New York at Buffalo
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Leonard H. Epstein, PH.D. Principal Investigator, University at Buffalo |
| ClinicalTrials.gov Identifier: | NCT01208870 History of Changes |
| Other Study ID Numbers: | 1083316-1-52205 |
| Study First Received: | September 23, 2010 |
| Last Updated: | September 23, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Substance-Related Disorders Obesity Mental Disorders Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013