Clinical trial NCT01708785: Learning Theory to Improve Obesity Treatment
Official title: Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-10-17
Enrollment: 230
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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).

Eligibility 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.

Primary outcomes:
measure: Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months
timeFrame: Change from baseline at an average of 3 months and 6 months
measure: Change in child weight
timeFrame: Change from baseline at an average of 3 and 6 months
Secondary outcomes:
measure: Change in parent weight from baseline at average of 3 and 6 months
timeFrame: Change from baseline at average of 3 and 6 months
measure: Change in attention to food cues from baseline at average of 3 and 6 months
timeFrame: Change from baseline at average of 3 and 6 months
measure: Change in impulsivity/Inhibition from baseline at average of 3 and 6 months
timeFrame: Change from baseline at average of 3 and 6 months
measure: Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months
timeFrame: Change from baseline at average of 3 and 6 months
measure: Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months
timeFrame: Change from baseline at average of 3 and 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Center for Health Eating and Activity Research
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
citation: Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
citation: Nederkoorn C, Smulders FT, Jansen A. Cephalic phase responses, craving and food intake in normal subjects. Appetite. 2000 Aug;35(1):45-55. doi: 10.1006/appe.2000.0328.
citation: Nederkoorn C, Jansen A. Cue reactivity and regulation of food intake. Eat Behav. 2002 Spring;3(1):61-72. doi: 10.1016/s1471-0153(01)00045-9.