Learning Theory to Improve Obesity Treatment (iROC)

October 16, 2017 updated by: Kerri Boutelle, University of California, San Diego

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Center for Health Eating and Activity Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Change 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
Time Frame: Change from baseline at an average of 3 and 6 months
BMI, BMIz
Change from baseline at an average of 3 and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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
Time Frame: Change 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 120431
  • 1R01DK094475-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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