- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009304
Effective Training Models for Implementing Health-Promoting Practices Afterschool
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Staff from afterschool sites that are run by the YMCA
- Staff from afterschool sites that serve elementary age children
- Staff from afterschool sites that run programming for the duration of the school year
Exclusion Criteria:
- Staff from afterschool sites that have already had experience implementing the OSNAP intervention
Study Plan
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
|
|
Experimental: In-person
OSNAP intervention delivered to afterschool sites using an in-person train-the-trainer model implementation strategy
|
Afterschool practice and policy change to support healthy eating and physical activity
|
Experimental: Online
OSNAP intervention delivered to afterschool sites using an online training model implementation strategy
|
Afterschool practice and policy change to support healthy eating and physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in nutrition and physical activity goals met (aggregate score)
Time Frame: Measured pre/post about 6 months apart
|
Effectiveness of the intervention will be measured with the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT)-an observational measure of nutrition and physical activity practices that site staff complete for one week before and after the intervention. Our team validated the tool with OST staff similar to those proposed to complete the measure in this study, establishing criterion validity for physical activity and nutrition outcomes with correlations ranging from 0.56 to 0.85 when compared with accelerometry and direct observation of dietary intake. Minimum goals possible: 0; Maximum goals possible: 9 Higher values represent better outcomes |
Measured pre/post about 6 months apart
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in % of days offering physical activity, screentime, fruits and vegetables, water, juice, whole grains, and sugary drinks from outside the program
Time Frame: Measured pre/post about 6 months apart
|
Using same Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT measure) - components of aggregate score Minimum days possible: 0%; Maximum days possible: 100% Higher values represent better outcomes
|
Measured pre/post about 6 months apart
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of the implementation strategy
Time Frame: Measured up to 1 year after baseline
|
Data on personnel, travel, and material costs collected via activity logs and administrative records
|
Measured up to 1 year after baseline
|
Reach: number of children and afterschool staff impacted by each implementation strategy
Time Frame: Measured at baseline
|
Collected on registration forms and via administrative records
|
Measured at baseline
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6928483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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