Study on Out of School Nutrition and Physical Activity Environments (OSNAP)
This study has been completed.
Sponsor:
Harvard School of Public Health
Collaborator:
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01396473
First received: January 27, 2011
Last updated: July 15, 2011
Last verified: July 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2011 | ||||
| Last Updated Date | July 15, 2011 | ||||
| Start Date ICMJE | September 2010 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in physical activity [ Time Frame: Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention ] [ Designated as safety issue: No ] Accelerometer and SOPLAY observation |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01396473 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change in dietary intake [ Time Frame: Participants' dietary intake will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention ] [ Designated as safety issue: No ] plate waste consumption |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study on Out of School Nutrition and Physical Activity Environments | ||||
| Official Title ICMJE | Study on Out of School Nutrition and Physical Activity Environments | ||||
| Brief Summary | The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants. |
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| Detailed Description | Nearly half of Boston's school age children (49%) participate in out of school time programs, a critical time to intervene on physical activity and nutrition. Previous research has mostly focused on during-school-day efforts, or on child care policies and practices for very young children, leaving a gap in the knowledge of what might work with programs serving school-age children during out of school time. OSNAP aims to implement low cost and sustainable policy and environmental interventions to improve physical activity and healthy eating/beverage environments. Data will be collected via observations, plate waste and accelerometers on program policies, environments, practices and behavioral outcomes related to physical activity, beverage, snack and screen time outcomes. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Policy and Environmental Change
Afterschool programs participate in an assessment of physical activity and nutrition practices and policies. Study staff work with teams of afterschool programs in a participatory manner to identify areas in which programs would like to take practice, policy and communication efforts to meet physical activity and nutrition goals. Teams share progress and barriers during ongoing collaborative meetings. |
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| Study Arm (s) |
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| Publications * | Giles CM, Kenney EL, Gortmaker SL, Lee RM, Thayer JC, Mont-Ferguson H, Cradock AL. Increasing water availability during afterschool snack: evidence, strategies, and partnerships from a group randomized trial. Am J Prev Med. 2012 Sep;43(3 Suppl 2):S136-42. doi: 10.1016/j.amepre.2012.05.013. | ||||
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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 | 590 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 12 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 | NCT01396473 | ||||
| Other Study ID Numbers ICMJE | 18046, CDC Grant Number | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven Gortmaker/Professor of the Practice of Health Sociology, Department of Society, Human Development and Health; Harvard School of Public Helath | ||||
| Study Sponsor ICMJE | Harvard School of Public Health | ||||
| Collaborators ICMJE | Centers for Disease Control and Prevention | ||||
| Investigators ICMJE |
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| Information Provided By | Harvard School of Public Health | ||||
| Verification Date | July 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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