Learning Theory to Improve Obesity Treatment (iROC)

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: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment; Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment; Behavioral: Single food Cue Exposure Treatment; Behavioral: Multiple food Cue Exposure Treatment

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: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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	BMI, BMIz	Change from baseline at an average of 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent weight 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	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	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	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	Participants will rate their cravings on a scale of 1-10.	Change from baseline at average of 3 and 6 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)

Publications and helpful links

General Publications

• 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.
• Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
• 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.
• 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.

Helpful Links

• Center for Healthy Eating and Activity Research

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: treatment; body mass index; obesity; overweight; childhood obesity; intervention; cravings; BMI; weight; behavioral treatment; overweight children; overeating; family based treatment; eating in the absence of hunger; families with overweight child; overweight parents; cue exposure treatment; habituation to food cues; psychophysiological response to food cues; experiments
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 120431; 1R01DK094475-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO