Childhood Obesity Treatment Targeting Specific Behaviors
| Tracking Information | |||||
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| First Received Date ICMJE | November 28, 2005 | ||||
| Last Updated Date | April 19, 2012 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Z-BMI in children [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Z-BMI in children | ||||
| Change History | Complete list of historical versions of study NCT00259324 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Eating and activity behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Eating and activity behaviors | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Childhood Obesity Treatment Targeting Specific Behaviors | ||||
| Official Title ICMJE | Childhood Obesity Treatment Targeting Specific Behaviors | ||||
| Brief Summary | The US is in the midst of an obesity epidemic, affecting young children. The pediatric primary care setting is an ideal place to address this problem since most families have frequent contact with their pediatrician and a child's health status is regularly assessed in this setting. Recommendations for treating children with a body mass index (BMI) over the 85th percentile in the primary care setting have been developed by an Expert Committee on childhood. Programs are needed that meet the recommendations from the Committee, which include: 1) beginning treatment as young as possible; 2) focusing on the family, with the parent being the primary change agent for treatment; 3) using behavior modification techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific changes in diet and activity at one time. Thus, the aim of this R21 application is to develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that meets the Committee's recommendations and can be implemented in a primary care setting. A second aim of this project is to determine which eating and activity behaviors should be targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI > 85th percentile, assessed and referred by their pediatricians, will be randomized to one of three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases physical activity (60 min/day) and decreases sweetened drink consumption (< 3 servings/week) (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (< 2 hours/day) and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to families, regarding weight and height status, following the assessments. This pilot study allows us to determine the feasibility and efficacy of a pediatric obesity intervention that optimizes the role of the pediatrician and meets the Committee's recommendations for treatment in a primary care setting. Moreover, by comparing the effects of targeting the traditional or substitute behaviors, data will be obtained for a power analysis for a full-scale trial of the effects of these two approaches on long-term weight loss. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Childhood Obesity | ||||
| Intervention ICMJE | Behavioral: Diet and Activity
Diet and Activity |
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| Study Arm (s) |
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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 | ||||
| Enrollment ICMJE | 81 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years to 9 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00259324 | ||||
| Other Study ID Numbers ICMJE | 1-R21-DK07491901 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | The Miriam Hospital | ||||
| Study Sponsor ICMJE | The Miriam Hospital | ||||
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| Investigators ICMJE |
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| Information Provided By | The Miriam Hospital | ||||
| Verification Date | December 2007 | ||||
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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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