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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01396473
Other study ID # 18046
Secondary ID CDC Grant Number
Status Completed
Phase N/A
First received January 27, 2011
Last updated July 15, 2011
Start date September 2010
Est. completion date June 2011

Study information

Verified date July 2011
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 590
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 12 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Harvard Prevention Research Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Harvard School of Public Health Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in physical activity Accelerometer and SOPLAY observation Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention No
Secondary Change in dietary intake 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 No
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