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Learning Theory to Improve Obesity Treatment (iROC)

University of California San Diego logo

University of California San Diego

Status

Completed

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01708785
1R01DK094475-01A1 (U.S. NIH Grant/Contract)
120431

Details and patient eligibility

About

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

Full 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).

Enrollment

230 patients

Sex

All

Ages

8 to 13 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

230 participants in 4 patient groups

Single context
Active Comparator group
Description:
Subjects will be exposed to food cues in a single context.
Treatment:
Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment
Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment
Multiple contexts
Experimental group
Description:
Subjects will be exposed to food cues in multiple contexts.
Treatment:
Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment
Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment
8 treatment sessions
Active Comparator group
Description:
Subjects receive 8 treatment sessions.
Treatment:
Behavioral: Multiple food Cue Exposure Treatment
Behavioral: Single food Cue Exposure Treatment
16 treatment sessions
Experimental group
Description:
Subjects receive 16 treatment sessions
Treatment:
Behavioral: Multiple food Cue Exposure Treatment
Behavioral: Single food Cue Exposure Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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