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
About this trial
This is an interventional other trial for Childhood Obesity
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.
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
NCT ID
NCT02144519
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)
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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