search
Back to results

Translating Habituation Research to Interventions for Pediatric Obesity (EAT)

Primary Purpose

Pediatric Obesity, Habituation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Variety Group
Nutrition Education Control
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Variety Group

Nutrition Education Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Child Body Composition
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
Parent Body Mass Index (kg/m^2) difference from baseline to 6 months

Secondary Outcome Measures

Change in Dietary Intake of Calories
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
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
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
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.

Full Information

First Posted
September 23, 2010
Last Updated
October 1, 2020
Sponsor
State University of New York at Buffalo
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT01208870
Brief Title
Translating Habituation Research to Interventions for Pediatric Obesity
Acronym
EAT
Official Title
Translating Habituation Research to Interventions for Pediatric Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Habituation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Variety Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Education Control
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Variety Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education Control
Intervention Description
The intervention will consist of our traditional family based weight control intervention.
Primary Outcome Measure Information:
Title
Change of Child Body Composition
Description
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.
Time Frame
Baseline to 6 months
Title
Change Parent Body Composition
Description
Parent Body Mass Index (kg/m^2) difference from baseline to 6 months
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Dietary Intake of Calories
Description
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.
Time Frame
Baseline to 6 months
Title
Change in Parent Delay Discounting
Description
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)
Time Frame
Baseline to 6 months
Title
Change in Child Delay Discounting
Description
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).
Time Frame
Baseline to 6 months
Title
Changes in Variety Measures
Description
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.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard H. Epstein, Ph.D.
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared under the specifics of this protocol. Outcome data will be published.
Citations:
PubMed Identifier
25706950
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.
Results Reference
derived
PubMed Identifier
23085682
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.
Results Reference
derived
PubMed Identifier
21593492
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.
Results Reference
derived

Learn more about this trial

Translating Habituation Research to Interventions for Pediatric Obesity

We'll reach out to this number within 24 hrs