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Clinical Trials/NCT01208870
NCT01208870CompletedNot Applicable

Translating Habituation Research to Interventions for Pediatric Obesity

State University of New York at Buffalo1 site in 1 country94 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
94
Locations
1
Primary Endpoint
Change of Child Body Composition

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
8 Years to 12 Years (Child)
Sex
All
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.
  • •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.

Arms & Interventions

Variety Group

Experimental

Traditional family based weight control treatment program with components to reduce variety of high energy dense foods incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.

Intervention: Variety Group (Behavioral)

Variety Group

Experimental

Traditional family based weight control treatment program with components to reduce variety of high energy dense foods incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.

Intervention: Nutrition Education Control (Behavioral)

Nutrition Education Control

Experimental

Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.

Intervention: Nutrition Education Control (Behavioral)

Outcomes

Primary Outcomes

Change of Child Body Composition

Time Frame: Baseline to 6 months

Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.

Change Parent Body Composition

Time Frame: Baseline to 6 months

Parent Body Mass Index (kg/m\^2) difference from baseline to 6 months

Secondary Outcomes

  • Change in Dietary Intake of Calories(Baseline to 6 months)
  • Change in Child Delay Discounting(Baseline to 6 months)
  • Change in Parent Delay Discounting(Baseline to 6 months)
  • Changes in Variety Measures(Baseline to 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leonard Epstein

Principal Investigator

State University of New York at Buffalo

Study Sites (1)

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