A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity
ROC
Self-Regulation Treatment for Pediatric Obesity
1 other identifier
interventional
236
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started May 2008
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedSeptember 8, 2017
September 1, 2017
2.5 years
August 2, 2011
September 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months
Baseline and 3 months
Secondary Outcomes (1)
Change from baseline in BMI-for-age at 3 months.
Baseline and 3 months
Study Arms (4)
Appetitie Awareness
EXPERIMENTALParents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter."
Cue Reactivity and Sensitivity Training
EXPERIMENTALParents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues.
Combined CAAT/CRST
EXPERIMENTALIn 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.
Control
NO INTERVENTIONBetween 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.
PMID: 24459240DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2011
First Posted
September 28, 2011
Study Start
May 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 8, 2017
Record last verified: 2017-09