- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01396473
Study on Out of School Nutrition and Physical Activity Environments (OSNAP)
July 15, 2011 updated by: Harvard School of Public Health (HSPH)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
590
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Harvard Prevention Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Afterschool programs in Boston MA serving at least 40 children ages 5-12 years operating the full school year between September and June
- Afterschool programs serving a snack to children
- Children between the ages of 5 and 12 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
|
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Experimental: Policy and Environmental Change
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Accelerometer and SOPLAY observation
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Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
plate waste consumption
|
Participants' dietary intake will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Steven Gortmaker, PhD, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Virgara R, Phillips A, Lewis LK, Baldock K, Wolfenden L, Ferguson T, Richardson M, Okely A, Beets M, Maher C. Interventions in outside-school hours childcare settings for promoting physical activity amongst schoolchildren aged 4 to 12 years. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013380. doi: 10.1002/14651858.CD013380.pub2.
- Lee RM, Giles CM, Cradock AL, Emmons KM, Okechukwu C, Kenney EL, Thayer J, Gortmaker SL. Impact of the Out-of-School Nutrition and Physical Activity (OSNAP) Group Randomized Controlled Trial on Children's Food, Beverage, and Calorie Consumption among Snacks Served. J Acad Nutr Diet. 2018 Aug;118(8):1425-1437. doi: 10.1016/j.jand.2018.04.011.
- Cradock AL, Barrett JL, Giles CM, Lee RM, Kenney EL, deBlois ME, Thayer JC, Gortmaker SL. Promoting Physical Activity With the Out of School Nutrition and Physical Activity (OSNAP) Initiative: A Cluster-Randomized Controlled Trial. JAMA Pediatr. 2016 Feb;170(2):155-62. doi: 10.1001/jamapediatrics.2015.3406.
- Lee RM, Emmons KM, Okechukwu CA, Barrett JL, Kenney EL, Cradock AL, Giles CM, deBlois ME, Gortmaker SL. Validity of a practitioner-administered observational tool to measure physical activity, nutrition, and screen time in school-age programs. Int J Behav Nutr Phys Act. 2014 Nov 28;11:145. doi: 10.1186/s12966-014-0145-5.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 27, 2011
First Submitted That Met QC Criteria
July 15, 2011
First Posted (Estimate)
July 18, 2011
Study Record Updates
Last Update Posted (Estimate)
July 18, 2011
Last Update Submitted That Met QC Criteria
July 15, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 18046
- CDC Grant Number (Other Grant/Funding Number: Centers for Disease Control and Prevention/1 -U48-DP-001946)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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