Childhood Obesity
Conditions
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.
Interventions
BEHAVIORALHealthy Eating and Physical Activity
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Children Meeting Physical Activity Policy | Spring of Year 1, Year 2, and Year 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Nutritional Quality of Snacks | Spring of Year 1, Year 2, and Year 3 | 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) |
Participant flow
Pre-assignment details
Differences between the total number of children with outcome measures collected and the number of children measured at baseline is due to the use of a repeated-cross sectional design where a total of 2635 unique children were measured across 3 years and a subset with 2 or more years participating in outcome measurements.
Participants by arm
| Arm | Count |
|---|---|
| Delayed Intervention This arm served as a comparison group for the first year and received the Healthy Eating and Physical Activity intervention in year 3 along with arm 1.
Healthy Eating and Physical Activity: Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards. | 870 |
| Immediate Intervention This arm receives the Healthy Eating and Physical Activity intervention in ASPs intervention immediately for a full year before the delayed intervention begins. This arm gets the intervention and support for two years.
Healthy Eating and Physical Activity: Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards. | 895 |
| Total | 1,765 |
Baseline characteristics
| Characteristic | Delayed Intervention | Immediate Intervention | Total |
|---|---|---|---|
| Age, Continuous | 8.1 years STANDARD_DEVIATION 1.8 | 7.9 years STANDARD_DEVIATION 1.8 | 8.0 years STANDARD_DEVIATION 1.8 |
| Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr Boys | 31.8 % Achieving MVPA Standard | 35.6 % Achieving MVPA Standard | 33.2 % Achieving MVPA Standard |
| Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr Girls | 15 % Achieving MVPA Standard | 16.2 % Achieving MVPA Standard | 15.5 % Achieving MVPA Standard |
| Race/Ethnicity, Customized Black | 389 Participants | 266 Participants | 655 Participants |
| Race/Ethnicity, Customized Other | 60 Participants | 51 Participants | 111 Participants |
| Race/Ethnicity, Customized White | 421 Participants | 578 Participants | 999 Participants |
| Region of Enrollment United States | 870 Participants | 895 Participants | 1765 Participants |
| Sex: Female, Male Female | 414 Participants | 417 Participants | 831 Participants |
| Sex: Female, Male Male | 456 Participants | 478 Participants | 934 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Spring of Year 1, Year 2, and Year 3
Population: Analysis based on the percentage of children (boys and girls, separately) achieving the 30 min MVPA standard
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 1 - Boys | 35.9 Percent children achieving MVPA standard |
| Immediate Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 2 - Boys | 44.2 Percent children achieving MVPA standard |
| Immediate Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 3 - Boys | 47.0 Percent children achieving MVPA standard |
| Immediate Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 1- Girls | 19.1 Percent children achieving MVPA standard |
| Immediate Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 2 - Girls | 24.3 Percent children achieving MVPA standard |
| Immediate Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 3 - Girls | 21.6 Percent children achieving MVPA standard |
| Delayed Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 2 - Girls | 12.3 Percent children achieving MVPA standard |
| Delayed Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 1 - Boys | 29.0 Percent children achieving MVPA standard |
| Delayed Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 1- Girls | 13.1 Percent children achieving MVPA standard |
| Delayed Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 2 - Boys | 29.3 Percent children achieving MVPA standard |
| Delayed Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 3 - Girls | 19.1 Percent children achieving MVPA standard |
| Delayed Intervention | Change in Percentage of Children Meeting Physical Activity Policy | Year 3 - Boys | 31.3 Percent children achieving MVPA standard |
p-value: 0.00895% CI: [1.18, 3]Mixed Models Analysis
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)
Time frame: Spring of Year 1, Year 2, and Year 3
Population: Direct observation of the number of days per week a fruit or vegetable was served
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention | Changes in Nutritional Quality of Snacks | Year 3 | 4.3 Days/Week Fruit/Vegetables served | Standard Deviation 1.7 |
| Immediate Intervention | Changes in Nutritional Quality of Snacks | Year 1 | 0.6 Days/Week Fruit/Vegetables served | Standard Deviation 1.6 |
| Immediate Intervention | Changes in Nutritional Quality of Snacks | Year 2 | 4.1 Days/Week Fruit/Vegetables served | Standard Deviation 1.9 |
| Delayed Intervention | Changes in Nutritional Quality of Snacks | Year 1 | 0.7 Days/Week Fruit/Vegetables served | Standard Deviation 1.8 |
| Delayed Intervention | Changes in Nutritional Quality of Snacks | Year 2 | 0.8 Days/Week Fruit/Vegetables served | Standard Deviation 1.8 |
| Delayed Intervention | Changes in Nutritional Quality of Snacks | Year 3 | 1.7 Days/Week Fruit/Vegetables served | Standard Deviation 2.4 |
p-value: 0.00395% CI: [1.45, 9.95]Regression, Logistic