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A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity (ROC)

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ClinicalTrials.gov Identifier: NCT01442142
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:

The objective of this study is to pilot test, evaluate and compare the effects of Cue Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT) in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce eating in the absence of hunger in overweight children immediately following treatment and 6-months post treatment.

The primary aim of this proposed study is to evaluate the efficacy and compare the effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight children. Following this first intervention, a second intervention to determine the efficacy of a combination program (combined CAAT & CRST) will be implemented.

The secondary aim of this study is to evaluate change in the following related measures for both children and adults who participated in CRST, CAAT, and the combination program: BMI for age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk food situations.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: CAAT: Appetite Awareness Behavioral: CRST: Volcravo Behavioral: Combined CAAT and CRST program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-Regulation Treatment for Pediatric Obesity
Study Start Date : May 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Appetitie Awareness
Parents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter."
 Behavioral: CAAT: Appetite Awareness
Participants in this Children's Appetite Awareness Training (CAAT) group learn to get in touch with the internal cues of hunger - aka the "hunger meter" - and practice skills to get back in touch with these internal cues of true hunger and fullness. Sessions occur once a week for 8 weeks.
Experimental: Cue Reactivity and Sensitivity Training
Parents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues.
 Behavioral: CRST: Volcravo
Participants in this Cue Reactivity and Sensitivity Training (CRST) group learn about how external cues can affect when and how much we eat (aka "volcravo - the craving volcano"). Over 8 weekly sessions, they practice skills to ride out the cravings external cues can cause.
Experimental: Combined CAAT/CRST
In this 14 week intervention combining Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST), parents and kids learn about both internal hunger cues and external cues that can cause one to overeat. Skills to learn the internal hunger cues and better responses to external cues are taught.
 Behavioral: Combined CAAT and CRST program
Participants meet weekly for 14 weeks to learn about both Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST) - i.e. appetite awareness and external cues that affect food intake.
No Intervention: Control
Between baseline and the post-intervention data collection point, no intervention is given. Participants are given a take home binder of intervention materials at that second data collection point; they have the option of reviewing the material prior to the final follow-up data collection point.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months [ Time Frame: Baseline and 3 months ]

Secondary Outcome Measures :
  1. Change from baseline in BMI-for-age at 3 months. [ Time Frame: Baseline and 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) greater than the 85%-ile
  • child consumes 10%+ of daily caloric need during Eating in the absence of hunger (EAH) assessment
  • child between the age of 8-12 at the time of the first data collection visit

Exclusion Criteria:

  • non-English speaking
  • history of eating disorder
  • food allergies
  • unavailable on days of intervention meetings
  • current participation in a weight loss or maintenance program
  • presence of any medical condition affecting weight or growth
  • presence of any physical, emotional, or behavioral disability that would prevent participant from taking part in the weekly study visits or the three data collection visits.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442142


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kerri Boutelle, PhD University of Minnesota, now Univ of CA, San Diego
Principal Investigator: Lisa J Harnack, DrPH University of Minnesota
Principal Investigator: Carol Peterson, PhD University of Minnesota
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01442142    
Other Study ID Numbers: AHC FRD 06-32
AHC FRD 06-32 ( Other Grant/Funding Number: University of Minnesota )
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Keywords provided by University of Minnesota:
obesity
pediatric
childhood
overweight
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight