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Learning Theory to Improve Obesity Treatment (iROC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of California, San Diego
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01708785
First received: October 11, 2012
Last updated: November 3, 2016
Last verified: November 2016
  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: 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

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)

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

Primary Outcome Measures:
  • Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months [ Time Frame: Change from baseline at an average of 3 months and 6 months ] [ Designated as safety issue: No ]
    Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.

  • Change in child weight [ Time Frame: Change from baseline at an average of 3 and 6 months ] [ Designated as safety issue: No ]
    BMI, BMIz


Secondary Outcome Measures:
  • Change in parent weight from baseline at average of 3 and 6 months [ Time Frame: Change from baseline at average of 3 and 6 months ] [ Designated as safety issue: No ]
    Measured by BMI (Body Mass Index)

  • Change in attention to food cues from baseline at average of 3 and 6 months [ Time Frame: Change from baseline at average of 3 and 6 months ] [ Designated as safety issue: No ]
    Reduce attention to food cues, redirect attention to neutral (non-food cues). Measured by computer program measuring response time

  • Change in impulsivity/Inhibition from baseline at average of 3 and 6 months [ Time Frame: Change from baseline at average of 3 and 6 months ] [ Designated as safety issue: No ]
    Reduce impulsive behavior response to both food and non-food cues. Measured by behavioral tasks

  • Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months [ Time Frame: Change from baseline at average of 3 and 6 months ] [ Designated as safety issue: No ]
    Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability.

  • Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months [ Time Frame: Change from baseline at average of 3 and 6 months ] [ Designated as safety issue: No ]
    Participants will rate their cravings on a scale of 1-10.


Estimated Enrollment: 230
Study Start Date: October 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single context
Subjects will be exposed to food cues in a single context.
Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment
Subjects will take random additional tastes of the food during cue exposure treatment.
Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment
Subjects will consistently take the same tastes of the food during cue exposure treatment.
Experimental: Multiple contexts
Subjects will be exposed to food cues in multiple contexts.
Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment
Subjects will take random additional tastes of the food during cue exposure treatment.
Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment
Subjects will consistently take the same tastes of the food during cue exposure treatment.
Active Comparator: 8 treatment sessions
Subjects receive 8 treatment sessions.
Behavioral: Single food Cue Exposure Treatment
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple food Cue Exposure Treatment
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Experimental: 16 treatment sessions
Subjects receive 16 treatment sessions
Behavioral: Single food Cue Exposure Treatment
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Behavioral: Multiple food Cue Exposure Treatment
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.

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).
  Eligibility

Ages Eligible for Study:   8 Years to 13 Years   (Child)
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708785

Contacts
Contact: Cyrielle Hacher, BA chacher@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: Cyrielle Hacher, BA       chacher@ucsd.edu   
Contact: Kerri Boutelle, Ph.D.       kboutelle@ucsd.edu   
Principal Investigator: Kerri Boutelle, Ph.D.         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: November 3, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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 December 07, 2016