Translating Habituation Research to Interventions for Pediatric Obesity

Pediatric Obesity Clinical Trial

— EAT  

Official title:

Translating Habituation Research to Interventions for Pediatric Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208870
• Other study ID #: 1083316-1-52205
• Secondary ID: 5U01DK088380
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: October 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Habituation
• Obesity
• Pediatric Obesity
• Substance-Related Disorders

Intervention

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.
• Nutrition Education Control
The intervention will consist of our traditional family based weight control intervention.

Locations

Country	Name	City	State
United States	University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 6 months
Primary	Change Parent Body Composition	Parent Body Mass Index (kg/m^2) difference from baseline to 6 months	Baseline to 6 months
Secondary	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.	Baseline to 6 months
Secondary	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)	Baseline to 6 months
Secondary	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).	Baseline to 6 months
Secondary	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.	Baseline to 6 months