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Translating Habituation Research to Interventions for Pediatric Obesity (EAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01208870
First Posted: September 24, 2010
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
State University of New York at Buffalo
  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
Pediatric Obesity Habituation Behavioral: Variety Group Behavioral: Nutrition Education Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Translating Habituation Research to Interventions for Pediatric Obesity

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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change in Dietary Intake of Calories [ Time Frame: Baseline to 6 months ]
    Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed. The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.

  • Change in Parent Delay Discounting [ Time Frame: Baseline to 6 months ]
    Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values. (0.25 impulsive to 0.00016 not impulsive)

  • Change in Child Delay Discounting [ Time Frame: Baseline to 6 months ]
    Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).

  • Changes in Variety Measures [ Time Frame: Baseline to 6 months ]
    Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density. Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly. Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low. These foods contribute little nutrients to the diet and compete for consumption of healthier foods. Green foods are high in nutrient density and low in energy density. Most Green foods come from the fruit and vegetable groups. Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes. Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.


Enrollment: 94
Study Start Date: October 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Variety Group
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.
Behavioral: Variety Group
The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.
Behavioral: Nutrition Education Control
The intervention will consist of our traditional family based weight control intervention.
Experimental: Nutrition Education Control
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.
Behavioral: Nutrition Education Control
The intervention will consist of our traditional family based weight control intervention.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208870


Locations
United States, New York
University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Leonard H. Epstein, Ph.D. SUNY Buffalo
  More Information

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
5U01DK088380 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2010
First Posted: September 24, 2010
Results First Submitted: January 8, 2016
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared under the specifics of this protocol. Outcome data will be published.

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