Trial Outcomes & Findings for Physical Activity and Nutrition Intervention in Afterschool Programs (NCT NCT02144519)

Last Updated: 2020-11-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

2635 participants

Primary outcome timeframe

Spring of Year 1, Year 2, and Year 3

Results posted on

2020-11-16

Participant Flow

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.

Unit of analysis: Afterschool Programs

Participant milestones

Participant milestones
Measure	Immediate Intervention 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).	Delayed Intervention 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.
Year 1 STARTED	895 10	870 10
Year 1 COMPLETED	895 10	870 10
Year 1 NOT COMPLETED	0 0	0 0
Year 2 STARTED	763 10	864 10
Year 2 COMPLETED	763 10	864 10
Year 2 NOT COMPLETED	0 0	0 0
Year 3 STARTED	894 10	760 10
Year 3 COMPLETED	894 10	760 10
Year 3 NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physical Activity and Nutrition Intervention in Afterschool Programs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delayed Intervention n=870 Participants 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.	Immediate Intervention n=895 Participants 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.	Total n=1765 Participants Total of all reporting groups
Age, Continuous	8.1 years STANDARD_DEVIATION 1.8 • n=5 Participants	7.9 years STANDARD_DEVIATION 1.8 • n=7 Participants	8.0 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	414 Participants n=5 Participants	417 Participants n=7 Participants	831 Participants n=5 Participants
Sex: Female, Male Male	456 Participants n=5 Participants	478 Participants n=7 Participants	934 Participants n=5 Participants
Race/Ethnicity, Customized White	421 Participants n=5 Participants	578 Participants n=7 Participants	999 Participants n=5 Participants
Race/Ethnicity, Customized Black	389 Participants n=5 Participants	266 Participants n=7 Participants	655 Participants n=5 Participants
Race/Ethnicity, Customized Other	60 Participants n=5 Participants	51 Participants n=7 Participants	111 Participants n=5 Participants
Region of Enrollment United States	870 Participants n=5 Participants	895 Participants n=7 Participants	1765 Participants n=5 Participants
Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr Girls	15 % Achieving MVPA Standard n=5 Participants	16.2 % Achieving MVPA Standard n=7 Participants	15.5 % Achieving MVPA Standard n=5 Participants
Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr Boys	31.8 % Achieving MVPA Standard n=5 Participants	35.6 % Achieving MVPA Standard n=7 Participants	33.2 % Achieving MVPA Standard n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Immediate Intervention n=1290 Participants 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).	Delayed Intervention n=1345 Participants 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.
Change in Percentage of Children Meeting Physical Activity Policy Year 1 - Boys	35.9 Percent children achieving MVPA standard	29.0 Percent children achieving MVPA standard
Change in Percentage of Children Meeting Physical Activity Policy Year 2 - Boys	44.2 Percent children achieving MVPA standard	29.3 Percent children achieving MVPA standard
Change in Percentage of Children Meeting Physical Activity Policy Year 3 - Boys	47.0 Percent children achieving MVPA standard	31.3 Percent children achieving MVPA standard
Change in Percentage of Children Meeting Physical Activity Policy Year 1- Girls	19.1 Percent children achieving MVPA standard	13.1 Percent children achieving MVPA standard
Change in Percentage of Children Meeting Physical Activity Policy Year 2 - Girls	24.3 Percent children achieving MVPA standard	12.3 Percent children achieving MVPA standard
Change in Percentage of Children Meeting Physical Activity Policy Year 3 - Girls	21.6 Percent children achieving MVPA standard	19.1 Percent children achieving MVPA standard

SECONDARY outcome

Timeframe: 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

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)

Outcome measures

Outcome measures
Measure	Immediate Intervention n=10 Afterschool Programs 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).	Delayed Intervention n=10 Afterschool Programs 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.
Changes in Nutritional Quality of Snacks Year 1	0.6 Days/Week Fruit/Vegetables served Standard Deviation 1.6	0.7 Days/Week Fruit/Vegetables served Standard Deviation 1.8
Changes in Nutritional Quality of Snacks Year 2	4.1 Days/Week Fruit/Vegetables served Standard Deviation 1.9	0.8 Days/Week Fruit/Vegetables served Standard Deviation 1.8
Changes in Nutritional Quality of Snacks Year 3	4.3 Days/Week Fruit/Vegetables served Standard Deviation 1.7	1.7 Days/Week Fruit/Vegetables served Standard Deviation 2.4

Adverse Events

Delayed Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immediate Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael W Beets

University of South Carolina

Phone: 8037773003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place