Project Fit:a School- and Community-based Obesity Intervention (FIT)
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2011 | ||||
| Last Updated Date | June 28, 2011 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| 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 NCT01385046 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Project Fit:a School- and Community-based Obesity Intervention | ||||
| Official Title ICMJE | Project Fit:a School- and Community-based Intervention to Address Physical Activity and Healthy Eating Among Low-income Elementary School Children | ||||
| Brief Summary | Project FIT is a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: Project Fit
physical activity and nutrition education |
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| Study Arm (s) | Experimental: physical activity and nutrition
Intervention: Behavioral: Project Fit |
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| Publications * | Eisenmann JC, Alaimo K, Pfeiffer K, Paek HJ, Carlson JJ, Hayes H, Thompson T, Kelleher D, Oh HJ, Orth J, Randall S, Mayfield K, Holmes D. Project FIT: rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children. BMC Public Health. 2011 Jul 29;11:607. | ||||
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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 | 403 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 14 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 | NCT01385046 | ||||
| Other Study ID Numbers ICMJE | MSU-123 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Denise Holmes/Dean of Human Medicine, Michigan State University | ||||
| Study Sponsor ICMJE | Michigan State University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Michigan State University | ||||
| Verification Date | June 2011 | ||||
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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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