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| Tracking Information | |||||
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| First Received Date ICMJE | August 31, 2005 | ||||
| Last Updated Date | November 16, 2005 | ||||
| Start Date ICMJE | October 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00142012 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | School-Based Obesity Prevention Program | ||||
| Official Title ICMJE | School-Based Obesity Prevention Program | ||||
| Brief Summary | The overarching goal of this initiative is to reduce the prevalence and occurrence of obesity and increase the remission of obesity in children and adolescents through implementation of a Comprehensive School Nutrition Policy designed to promote changes in the school environment that will reinforce students’ development of healthy eating and physical activity patterns inside and outside of school. |
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| Detailed Description | The proposed research aims to evaluate the effects of a school-based nutrition policy initiative on prevalence, incidence and remission of overweight (BMI > 95th percentile). It is a partnership between the Food Trust, the School District of Philadelphia and the University of Pennsylvania. Participants are approximately 1500 students from ten schools in grades four through eight. Half of the schools were randomized to a comprehensive School Nutrition Policy Initiative (SNPI) based on CDC's Guidelines to Promote Lifelong Healthy Eating. The SNPI is a community-based intervention administered by the Comprehensive School Nutrition Policy Task Force that is comprised of 40 individuals representing the public and private sectors. The goal of the SNPI is to change the school environment to: support healthy eating, increase physical activity, and decrease the prevalence of childhood overweight and diet-related diseases. The remaining study participants are in five control schools, matched for ethnicity, SES, and type of food service. Most students are African American and qualify for free and reduced meals at school (household income < 185% of the poverty level adjusted for household size). Assessments of weight, height, intake, activity, inactivity and eating disorder symptomatology are being conducted at baseline and 1 and 2 years. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: Nutrition Intervention | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1500 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 14 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00142012 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDC-OPHR-321534 | ||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||
| Collaborators ICMJE | University of Pennsylvania | ||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||
| Verification Date | September 2005 | ||||
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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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