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Completed

NCT Number: NCT01708785

Learning Theory to Improve Obesity Treatment

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

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Eating and Activity Research

La Jolla, California, 92037, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single food Cue Exposure Treatment

Behavioral

Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.

Multiple food Cue Exposure Treatment

Behavioral

Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.

Partial Reinforcement - Enhanced Cue Exposure Treatment

Behavioral

Subjects will take random additional tastes of the food during cue exposure treatment.

Partial Reinforcement -Consistent Cue Exposure Treatment

Behavioral

Subjects will consistently take the same tastes of the food during cue exposure treatment.

Primary outcomes

  1. 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.

  2. Change in child weight

    Time frame: Change from baseline at an average of 3 and 6 months

    BMI, BMIz

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: iROC

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2012
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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