Translating Habituation Research to Interventions for Pediatric Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translating Habituation Research to Interventions for Pediatric Obesity

Conditions
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Pediatric Obesity, Habituation

Intervention / Treatment
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* Behavioral: Variety Group
* Behavioral: Nutrition Education Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Variety Group<br>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<br>* 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.<br>Behavioral: Nutrition Education Control<br>* The intervention will consist of our traditional family based weight control intervention.<br>|
| Experimental: Nutrition Education Control<br>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<br>* The intervention will consist of our traditional family based weight control intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change Parent Body Composition | Parent Body Mass Index (kg/m^2) difference from baseline to 6 months | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |