A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity (ROC)
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| ClinicalTrials.gov Identifier: NCT01442142 |
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Recruitment Status :
Completed
First Posted : September 28, 2011
Last Update Posted : September 8, 2017
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Sponsor:
University of Minnesota
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 2, 2011 | |||||||||
| First Posted Date ICMJE | September 28, 2011 | |||||||||
| Last Update Posted Date | September 8, 2017 | |||||||||
| Study Start Date ICMJE | May 2008 | |||||||||
| Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
Change from baseline in BMI-for-age at 3 months. [ Time Frame: Baseline and 3 months ] | |||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity | |||||||||
| Official Title ICMJE | Self-Regulation Treatment for Pediatric Obesity | |||||||||
| 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. |
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| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | 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. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
236 | |||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | November 2010 | |||||||||
| Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 8 Years to 12 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01442142 | |||||||||
| Other Study ID Numbers ICMJE | AHC FRD 06-32 AHC FRD 06-32 ( Other Grant/Funding Number: University of Minnesota ) |
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| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | University of Minnesota | |||||||||
| Original Responsible Party | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
| Current Study Sponsor ICMJE | University of Minnesota | |||||||||
| Original Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
| Investigators ICMJE |
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| PRS Account | University of Minnesota | |||||||||
| Verification Date | September 2017 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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