Learning Theory to Improve Obesity Treatment

Study Overview
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Brief Summary
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The purpose of this study is to optimize an obesity treatment program targeting overweight 8-12 year old children using Cue Exposure Training.

Detailed Description
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The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy foods. Through a series of experimental studies, the investigators will evaluate how many weekly treatment visits there should be, whether children should be exposed to a single food or multiple foods during treatment, whether to use partial reinforcement or not, whether visits should be daily or weekly, and whether the exposures should be in single or multiple contexts. The investigators will be recruiting parent-child dyads in the San Diego community to participate in 8 to 16 weekly or daily treatment sessions either in their home, community center, or our lab, depending on the treatment arm. Parents and children will complete baseline and post-treatment assessments consisting of collecting psychophysiological data, completing laboratory tasks, and completing questionnaires. The investigators will be evaluating which treatment condition reduces overeating (as measured by our laboratory tasks).

Official Title
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Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Single food Cue Exposure Treatment
* Behavioral: Multiple food Cue Exposure Treatment
* Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment
* Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Response to an advertisement for the study, An overweight or obese child in the family who is between the ages of 8 and 13, The 8-13 year old child must be above the 85th BMI % for age and gender, Parent willing to participate and attend all meetings, Parent who can read at a minimum of a 5th grade level in English, Parent and child willing to commit to attendance and assessments, Child who eats in the absence of hunger. Exclusion Criteria: Major child psychiatric disorder diagnoses, An obese child over the 99.9th BMI % Child or parent diagnoses of diabetes for which physician supervision of diet is needed or diagnosis of serious current physical diseases (such as cancer, multiple sclerosis, lupus) which could significantly decrease their ability to participate in the intervention (parent report), Child taking a medication that can affect cognitive functioning, such as attention, concentration, or mental status. Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home (these restrictions affect their ability participate in the food exposures because it would limit the variety of foods available to do exposures with), Child with an active eating disorder (based on parent and child self-report) Major parent psychiatric or eating disorder.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 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 |
| --- | --- |
| Active Comparator: Single context<br>Subjects will be exposed to food cues in a single context. | Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment<br>* Subjects will take random additional tastes of the food during cue exposure treatment.<br>Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment<br>* Subjects will consistently take the same tastes of the food during cue exposure treatment.<br>|
| Experimental: Multiple contexts<br>Subjects will be exposed to food cues in multiple contexts. | Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment<br>* Subjects will take random additional tastes of the food during cue exposure treatment.<br>Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment<br>* Subjects will consistently take the same tastes of the food during cue exposure treatment.<br>|
| Active Comparator: 8 treatment sessions<br>Subjects receive 8 treatment sessions. | Behavioral: Single food Cue Exposure Treatment<br>* Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.<br>Behavioral: Multiple food Cue Exposure Treatment<br>* Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.<br>|
| Experimental: 16 treatment sessions<br>Subjects receive 16 treatment sessions | Behavioral: Single food Cue Exposure Treatment<br>* Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.<br>Behavioral: Multiple food Cue Exposure Treatment<br>* Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months | Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues. | Change from baseline at an average of 3 months and 6 months | 
| Change in child weight | BMI, BMIz | Change from baseline at an average of 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parent weight from baseline at average of 3 and 6 months | Measured by BMI (Body Mass Index) | Change from baseline at average of 3 and 6 months | 
| Change in attention to food cues from baseline at average of 3 and 6 months | Reduce attention to food cues, redirect attention to neutral (non-food cues). Measured by computer program measuring response time | Change from baseline at average of 3 and 6 months | 
| Change in impulsivity/Inhibition from baseline at average of 3 and 6 months | Reduce impulsive behavior response to both food and non-food cues. Measured by behavioral tasks | Change from baseline at average of 3 and 6 months | 
| Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months | Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability. | Change from baseline at average of 3 and 6 months | 
| Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months | Participants will rate their cravings on a scale of 1-10. | Change from baseline at average of 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, obesity, overweight, overweight children, overweight parents, overeating, eating in the absence of hunger, families with overweight child, body mass index, weight, childhood obesity, treatment, cue exposure treatment, cravings, habituation to food cues, psychophysiological response to food cues, intervention, experiments, family based treatment, behavioral treatment