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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
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring Nutrition, Physical activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 2, 2019
    Last Updated
    July 3, 2019
    Sponsor
    Harvard School of Public Health (HSPH)
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    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

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