Physical Activity and Nutrition Intervention in Afterschool Programs

Childhood Obesity Clinical Trial

Official title:

Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144519
• Other study ID #: 1R01HL112787-01A1
• Secondary ID: 1R01HL112787-01A
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: May 2016

Study information

• Verified date: November 2020
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2635
• Est. completion date: May 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Healthy Eating and Physical Activity
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Spring of Year 1, Year 2, and Year 3
Secondary	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)	Spring of Year 1, Year 2, and Year 3