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Physical Activity and Nutrition Intervention in Afterschool Programs

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Eating and Physical Activity
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Childhood Obesity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Programs that:

  • Operate immediately after the school day
  • Operate every day of the school year for a minimum of 2 hours
  • Serve a minimum of 30 children of elementary age (6-12 years)
  • Operate in a school, community or faith Setting
  • Provide a snack
  • Provide homework assistance/completion time
  • Provide enrichment
  • Provide opportunities for physical activity
  • All children enrolled, staff, and afterschool program (ASP) leaders in the ASPs were eligible to participate in the study.

Exclusion Criteria:

  • Programs that:
  • Were singularly focused
  • Programs that were physical activity focused

Children that:

  • Have any physical and/or orthopedic impairment that would limit a child's ability to participate in regular physical activity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Immediate Intervention

    Delayed Intervention

    Arm Description

    Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).

    Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.

    Outcomes

    Primary Outcome Measures

    Change in Percentage of Children Meeting Physical Activity Policy
    We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity. The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry. All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+. The accelerometers were distilled using 5-second epochs. When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on). Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off). Children wore the monitors for their entire attendance at the ASPs. Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior. Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.

    Secondary Outcome Measures

    Changes in Nutritional Quality of Snacks
    We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week. These analyses were performed at the ASP level with a sample size of 20 (10 per arm)

    Full Information

    First Posted
    May 13, 2014
    Last Updated
    November 12, 2020
    Sponsor
    University of South Carolina
    Collaborators
    National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02144519
    Brief Title
    Physical Activity and Nutrition Intervention in Afterschool Programs
    Official Title
    Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of South Carolina
    Collaborators
    National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide. The investigators objective here is two fold. First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served. This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard). Second, the investigators will examine the barriers and facilitators to implementing these strategies. The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.
    Detailed Description
    The investigators will use a 3-year delayed treatment, cluster randomized controlled trial design with 20 ASPs that serve mostly low-income and minority children (approximately 1300 children ages 6-12yrs) in Columbia, SC and address the following specific aims: Aim 1. Evaluate the impact of a staff-level intervention, a professional development training program focused on core competencies to promote physical activity, on children's physical activity levels; Aim 2. Evaluate the impact of a site-level intervention, a snack modification program that includes a discount buying program, on the quality of snacks served and consumed; and Aim 3. Evaluate the implementation of the staff-level and site-level interventions and identify organizational, staff, and setting characteristics that influence the process of implementing these strategies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2635 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate Intervention
    Arm Type
    Experimental
    Arm Description
    Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3).
    Arm Title
    Delayed Intervention
    Arm Type
    Experimental
    Arm Description
    Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Eating and Physical Activity
    Other Intervention Name(s)
    HEPA
    Intervention Description
    Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
    Primary Outcome Measure Information:
    Title
    Change in Percentage of Children Meeting Physical Activity Policy
    Description
    We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity. The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry. All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+. The accelerometers were distilled using 5-second epochs. When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on). Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off). Children wore the monitors for their entire attendance at the ASPs. Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior. Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.
    Time Frame
    Spring of Year 1, Year 2, and Year 3
    Secondary Outcome Measure Information:
    Title
    Changes in Nutritional Quality of Snacks
    Description
    We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week. These analyses were performed at the ASP level with a sample size of 20 (10 per arm)
    Time Frame
    Spring of Year 1, Year 2, and Year 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Programs that: Operate immediately after the school day Operate every day of the school year for a minimum of 2 hours Serve a minimum of 30 children of elementary age (6-12 years) Operate in a school, community or faith Setting Provide a snack Provide homework assistance/completion time Provide enrichment Provide opportunities for physical activity All children enrolled, staff, and afterschool program (ASP) leaders in the ASPs were eligible to participate in the study. Exclusion Criteria: Programs that: Were singularly focused Programs that were physical activity focused Children that: Have any physical and/or orthopedic impairment that would limit a child's ability to participate in regular physical activity.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael W Beets, PhD
    Organizational Affiliation
    University of South Carolina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27397608
    Citation
    Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Bottai M, Chandler J, Brazendale K, Beighle A. Physical activity outcomes in afterschool programs: A group randomized controlled trial. Prev Med. 2016 Sep;90:207-15. doi: 10.1016/j.ypmed.2016.07.002. Epub 2016 Jul 7.
    Results Reference
    derived
    PubMed Identifier
    26158679
    Citation
    Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Freedman D, Hutto B, Moore JB, Beighle A. Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs. Am J Health Promot. 2016 Sep;30(7):521-31. doi: 10.4278/ajhp.141001-QUAN-486. Epub 2016 Jun 17.
    Results Reference
    derived
    PubMed Identifier
    25998921
    Citation
    Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Beighle A. Making policy practice in afterschool programs: a randomized controlled trial on physical activity changes. Am J Prev Med. 2015 Jun;48(6):694-706. doi: 10.1016/j.amepre.2015.01.012.
    Results Reference
    derived

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    Physical Activity and Nutrition Intervention in Afterschool Programs

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