Learning Theory to Improve Obesity Treatment (iROC)

This study is currently recruiting participants.
Verified October 2012 by University of California, San Diego
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01708785
First received: October 11, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Obesity
Behavioral: 8 treatment sessions
Behavioral: Cue exposure treatment (clinical trial)
Behavioral: Family-based Behavioral Treatment (FBT)
Behavioral: 16 treatment sessions
Behavioral: Single foods
Behavioral: Multiple foods
Behavioral: Daily sessions
Behavioral: Weekly sessions
Behavioral: Partial reinforcement - Yes
Behavioral: Partial reinforcement - No
Behavioral: Single context
Behavioral: Multiple contexts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Overeating (Eating in the absence of hunger) [ Time Frame: Change from baseline at 1 week after treatment completion ] [ Designated as safety issue: No ]
    Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.

  • Psychophysiological measures of responsivity to food cues [ Time Frame: Change from baseline at 1 week after treatment completion ] [ Designated as safety issue: No ]
    Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability.

  • Level of self-reported cravings in response to palatable food cues. [ Time Frame: Change from baseline at 1 week after treatment completion ] [ Designated as safety issue: No ]
    Participants will rate their cravings on a scale of 1-10.

  • Overeating (Eating in the absence of hunger) [ Time Frame: Change from baseline at 6 months after treatment completion ] [ Designated as safety issue: No ]
    Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.

  • Psychophysiological measures of responsivity to food cues [ Time Frame: Change from baseline at 6 months after treatment completion ] [ Designated as safety issue: No ]
    Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability.

  • Level of self-reported cravings in response to palatable food cues [ Time Frame: Change from baseline at 6 months after treatment completion ] [ Designated as safety issue: No ]
    Participants will rate their cravings on a scale of 1-10.


Secondary Outcome Measures:
  • Parent and child weight change [ Time Frame: Change from baseline at 1 week and 6 months after treatment completion ] [ Designated as safety issue: No ]
    Measured by BMI (Body Mass Index)

  • Child eating behaviors [ Time Frame: Change from baseline at 1 week and 6 months after treatment completion ] [ Designated as safety issue: No ]
    Measured by self-reported questionnaires

  • Parent feeding style [ Time Frame: Change from baseline at 1 week and 6 months after treatment completion ] [ Designated as safety issue: No ]
    Measured by self-reported questionnaires

  • Eating disorder behaviors and cognitions [ Time Frame: Change from baseline at 1 week and 6 months after treatment completion ] [ Designated as safety issue: No ]
    Binging, restricting, body image and shape concerns, maladaptive behaviors and cognitions for weight loss. Measured by interview and self-reported questionnaires

  • Treatment acceptability and preference [ Time Frame: 1 week after treatment completion ] [ Designated as safety issue: No ]
    Measured by questionnaires

  • Attention modification to food cues [ Time Frame: Change from baseline at 1 week and 6 months after treatment completion ] [ Designated as safety issue: No ]
    Reduce attention to food cues, redirect attention to neutral (non-food cues). Measured by computer program measuring response time

  • Impulsivity/Inhibition [ Time Frame: Change from baseline at 1 week and 6 months after treatment completion ] [ Designated as safety issue: No ]
    Reduce impulsive behavior response to both food and non-food cues. Measured by behavioral tasks


Estimated Enrollment: 230
Study Start Date: October 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single foods
Subjects exposed to same 4 foods.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Experimental: Daily sessions
Subjects will receive daily cue exposure sessions.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Active Comparator: Weekly sessions
Subjects will receive weekly cue exposure sessions.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Experimental: Single context
Subjects will be exposed to food cues in a single context.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Active Comparator: Multiple contexts
Subjects will be exposed to food cues in multiple contexts.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Experimental: Partial reinforcement - yes
Subjects will be tasting food during cue exposure treatment.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Active Comparator: Partial reinforcement - no
Subjects will not be tasting food during cue exposure treatment.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Experimental: Cue exposure treatment
Subjects will receive only the cue exposure treatment during the clinical trial phase of the study.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: Cue exposure treatment (clinical trial)
This version of the cue exposure treatment that will be provided in the clinical trial context will consist of the optimized components of the treatment as determined by the results of the experimental phase of this study.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Experimental: Cue exposure treatment + FBT
Subjects will receive the cue exposure treatment as an adjunct to the family-based behavioral treatment for weight loss (current gold standard treatment).
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: Cue exposure treatment (clinical trial)
This version of the cue exposure treatment that will be provided in the clinical trial context will consist of the optimized components of the treatment as determined by the results of the experimental phase of this study.
Behavioral: Family-based Behavioral Treatment (FBT)
This is the current gold standard treatment for behavioral weight loss that will be used to compare to the cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Active Comparator: Family-based behavioral treatment (FBT)
Subjects will receive the family-based behavioral treatment for weight loss (current gold standard treatment).
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: Family-based Behavioral Treatment (FBT)
This is the current gold standard treatment for behavioral weight loss that will be used to compare to the cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Active Comparator: Multiple foods
Subjects exposed to different set of 4 foods.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Experimental: 8 treatment sessions
Subjects receive 8 treatment sessions.
Behavioral: 8 treatment sessions
Subjects will receive 8 sessions of cue exposure treatment.
Behavioral: Cue exposure treatment (clinical trial)
This version of the cue exposure treatment that will be provided in the clinical trial context will consist of the optimized components of the treatment as determined by the results of the experimental phase of this study.
Behavioral: Family-based Behavioral Treatment (FBT)
This is the current gold standard treatment for behavioral weight loss that will be used to compare to the cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.
Active Comparator: 16 treatment sessions
Subjects receive 16 treatment sessions
Behavioral: Cue exposure treatment (clinical trial)
This version of the cue exposure treatment that will be provided in the clinical trial context will consist of the optimized components of the treatment as determined by the results of the experimental phase of this study.
Behavioral: Family-based Behavioral Treatment (FBT)
This is the current gold standard treatment for behavioral weight loss that will be used to compare to the cue exposure treatment.
Behavioral: 16 treatment sessions
Subjects will receive 16 sessions of cue exposure treatment.
Behavioral: Single foods
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple foods
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Behavioral: Daily sessions
Subjects will receive 8 or 16 daily cue exposure treatment sessions.
Behavioral: Weekly sessions
Subjects will receive 8 or 16 weekly cue exposure treatment sessions.
Behavioral: Partial reinforcement - Yes
Subjects will be asked to taste the food during cue exposure treatment.
Behavioral: Partial reinforcement - No
Subjects will NOT be asked to taste the food during cue exposure treatment.
Behavioral: Single context
Subjects will be exposed to foods in a single context during cue exposure treatment.
Behavioral: Multiple contexts
Subjects will be exposed to foods in multiple contexts during cue exposure treatment.

Detailed Description:

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).

Following these experimental studies, the investigators will use the most promising treatment and conduct a proof of concept study to look at the acceptability and feasibility of this intervention with existing behavioral weight loss treatments.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 12,
  • The 8-12 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708785

Contacts
Contact: June Liang, Ph.D. 858.534.8092 j1liang@ucsd.edu
Contact: Kerri Boutelle, Ph.D. kboutelle@ucsd.edu

Locations
United States, California
Center for Health Eating and Activity Research Recruiting
La Jolla, California, United States, 92037
Contact: June Liang, Ph.D.    858-534-8092    j1liang@ucsd.edu   
Contact: Kerri Boutelle, Ph.D.       kboutelle@ucsd.edu   
Principal Investigator: Kerri Boutelle, Ph.D.         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kerri Boutelle, Ph.D. UCSD
  More Information

Additional Information:
Publications:
Responsible Party: Kerri Boutelle, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01708785     History of Changes
Other Study ID Numbers: 120431, 1R01DK094475-01A1
Study First Received: October 11, 2012
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, San Diego:
obesity
childhood obesity
overweight
overweight children
overweight parents
overeating
eating in the absence of hunger
families with overweight child
body mass index
BMI
weight
treatment
cue exposure treatment
cravings
habituation to food cues
psychophysiological response to food cues
intervention
experiments
family based treatment
behavioral treatment

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014