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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAAT: Appetite Awareness
CRST: Volcravo
Combined CAAT and CRST program
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, pediatric, childhood, overweight

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Appetitie Awareness

Cue Reactivity and Sensitivity Training

Combined CAAT/CRST

Control

Arm Description

Parents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter."

Parents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months

Secondary Outcome Measures

Change from baseline in BMI-for-age at 3 months.

Full Information

First Posted
August 2, 2011
Last Updated
September 5, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01442142
Brief Title
A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity
Acronym
ROC
Official Title
Self-Regulation Treatment for Pediatric Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, pediatric, childhood, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appetitie Awareness
Arm Type
Experimental
Arm Description
Parents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter."
Arm Title
Cue Reactivity and Sensitivity Training
Arm Type
Experimental
Arm Description
Parents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues.
Arm Title
Combined CAAT/CRST
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CAAT: Appetite Awareness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CRST: Volcravo
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combined CAAT and CRST program
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change from baseline in BMI-for-age at 3 months.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Boutelle, PhD
Organizational Affiliation
University of Minnesota, now Univ of CA, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa J Harnack, DrPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol Peterson, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24459240
Citation
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.
Results Reference
derived

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

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