Effective Training Models for Implementing Health-Promoting Practices Afterschool
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OSNAP
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood focused on measuring Nutrition, Physical activity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
In-person
Online
Control
Arm Description
OSNAP intervention delivered to afterschool sites using an in-person train-the-trainer model implementation strategy
OSNAP intervention delivered to afterschool sites using an online training model implementation strategy
Outcomes
Primary Outcome Measures
Change from baseline in nutrition and physical activity goals met (aggregate score)
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
Secondary Outcome Measures
Change from baseline in % of days offering physical activity, screentime, fruits and vegetables, water, juice, whole grains, and sugary drinks from outside the program
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
Full Information
NCT ID
NCT04009304
First Posted
July 2, 2019
Last Updated
July 3, 2019
Sponsor
Harvard School of Public Health (HSPH)
1. Study Identification
Unique Protocol Identification Number
NCT04009304
Brief Title
Effective Training Models for Implementing Health-Promoting Practices Afterschool
Official Title
Effective Training Models for Implementing Health-Promoting Practices Afterschool
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study of the dissemination of the Out-of-school Nutrition and Physical Activity Initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. online) for an evidence-based out-of-school time (OST) nutrition and physical activity intervention. The study will compare sites that receive the training models with a control group. Investigators will work with YMCA leadership to recruit 45 demographically diverse YMCA OST sites from across the country. Sites will be matched on racial/ethnic composition, proportion of students eligible for free or reduced price meals, program enrollment, urban/rural/suburban setting, and physical activity and food service facilities available. One-third of the sites will be randomized to participate in the online training over the school year, one-third will participate in the in-person train-the-trainer model, and one-third will serve as controls. After randomization, in fall 2016, teams of YMCA OST directors and line staff will be invited to participate in the OSNAP learning collaborative trainings. The intervention follows the social ecological model with activities targeting multiple levels of change-school district/program sponsor, OST site, interpersonal, and individual-and emphasizing on adoption of the following OSNAP goals: ban sugar-sweetened drinks from snacks served and brought in from outside the snack program; offer water as a drink at snack every day; offer a fruit or vegetable option every day at snack; ban foods with trans fats from snacks served; serve whole grains; offer 30 minutes of physical activity to all children daily; offer 20 minutes of vigorous physical activity to all children 3 times per week; and eliminate television, movies, and non-educational screentime. Sessions are designed consistent with the Institute for Healthcare Improvement Breakthrough Series Collaborative model and use constructs from social cognitive theory-knowledge and skill development coupled with action planning-to drive environmental and behavior change. Teams of afterschool staff will use the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT), decision aids, policy writing guides, and other resources available at www.osnap.org to set data-driven goals and implement discrete practice, policy, and communication action steps throughout the year. Staff will also receive training on the Food & Fun After School curriculum available at foodandfun.org.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Nutrition, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assigned afterschool sites (not individual participants) to group with block randomization approach, delayed intervention design offered effective intervention to control group in year 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-person
Arm Type
Experimental
Arm Description
OSNAP intervention delivered to afterschool sites using an in-person train-the-trainer model implementation strategy
Arm Title
Online
Arm Type
Experimental
Arm Description
OSNAP intervention delivered to afterschool sites using an online training model implementation strategy
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
OSNAP
Intervention Description
Afterschool practice and policy change to support healthy eating and physical activity
Primary Outcome Measure Information:
Title
Change from baseline in nutrition and physical activity goals met (aggregate score)
Description
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
Time Frame
Measured pre/post about 6 months apart
Secondary Outcome Measure Information:
Title
Change from baseline in % of days offering physical activity, screentime, fruits and vegetables, water, juice, whole grains, and sugary drinks from outside the program
Description
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
Time Frame
Measured pre/post about 6 months apart
Other Pre-specified Outcome Measures:
Title
Cost of the implementation strategy
Description
Data on personnel, travel, and material costs collected via activity logs and administrative records
Time Frame
Measured up to 1 year after baseline
Title
Reach: number of children and afterschool staff impacted by each implementation strategy
Description
Collected on registration forms and via administrative records
Time Frame
Measured at baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31779603
Citation
Lee RM, Barrett JL, Daly JG, Mozaffarian RS, Giles CM, Cradock AL, Gortmaker SL. Assessing the effectiveness of training models for national scale-up of an evidence-based nutrition and physical activity intervention: a group randomized trial. BMC Public Health. 2019 Nov 28;19(1):1587. doi: 10.1186/s12889-019-7902-y.
Results Reference
derived
Learn more about this trial
Effective Training Models for Implementing Health-Promoting Practices Afterschool
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