Translating Habituation Research to Interventions for Pediatric Obesity (EAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by State University of New York at Buffalo
Sponsor:
Collaborator:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01208870
First received: September 23, 2010
Last updated: December 4, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208870

Contacts
Contact: Erin Brewer 716-829-6690 embrewer@buffalo.edu
Contact: Leonard H Epstein, Ph.D. 716-829-3400 lhenet@acsu.buffalo.edu

Locations
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.         
Sponsors and Collaborators
State University of New York at Buffalo
  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: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01208870     History of Changes
Other Study ID Numbers: 1083316-1-52205
Study First Received: September 23, 2010
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Substance-Related Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014