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Learning Theory to Improve Obesity Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01708785
Acronym
iROC
Enrollment
230
Registered
2012-10-17
Start date
2012-10-31
Completion date
2017-09-30
Last updated
2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

Brief summary

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

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).

Interventions

BEHAVIORALSingle food Cue Exposure Treatment

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

BEHAVIORALMultiple food Cue Exposure Treatment

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

BEHAVIORALPartial Reinforcement - Enhanced Cue Exposure Treatment

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

BEHAVIORALPartial Reinforcement -Consistent Cue Exposure Treatment

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in child weightChange from baseline at an average of 3 and 6 monthsBMI, BMIz
Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 monthsChange from baseline at an average of 3 months and 6 monthsReduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.

Secondary

MeasureTime frameDescription
Change in parent weight from baseline at average of 3 and 6 monthsChange from baseline at average of 3 and 6 monthsMeasured by BMI (Body Mass Index)
Change in attention to food cues from baseline at average of 3 and 6 monthsChange from baseline at average of 3 and 6 monthsReduce 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 monthsChange from baseline at average of 3 and 6 monthsReduce 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 monthsChange from baseline at average of 3 and 6 monthsSalivation/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 monthsChange from baseline at average of 3 and 6 monthsParticipants will rate their cravings on a scale of 1-10.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026