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Physical Activity and Nutrition Intervention in Afterschool Programs

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ClinicalTrials.gov Identifier: NCT02144519
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Childhood Obesity
Intervention Behavioral: Healthy Eating and Physical Activity
Enrollment 2635
Recruitment Details  
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.
Arm/Group Title Immediate Intervention Delayed Intervention
Hide Arm/Group 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.
Period Title: Year 1
Number of participants Number of units (Afterschool Programs) Number of participants Number of units (Afterschool Programs)
Started 895 10 870 10
Completed 895 10 870 10
Not Completed 0 0 0 0
Period Title: Year 2
Number of participants Number of units (Afterschool Programs) Number of participants Number of units (Afterschool Programs)
Started 763 10 864 10
Completed 763 10 864 10
Not Completed 0 0 0 0
Period Title: Year 3
Number of participants Number of units (Afterschool Programs) Number of participants Number of units (Afterschool Programs)
Started 894 10 760 10
Completed 894 10 760 10
Not Completed 0 0 0 0
Arm/Group Title Delayed Intervention Immediate Intervention Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 870 895 1765
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 870 participants 895 participants 1765 participants
8.1  (1.8) 7.9  (1.8) 8.0  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 870 participants 895 participants 1765 participants
Female
414
  47.6%
417
  46.6%
831
  47.1%
Male
456
  52.4%
478
  53.4%
934
  52.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 870 participants 895 participants 1765 participants
White
421
  48.4%
578
  64.6%
999
  56.6%
Black
389
  44.7%
266
  29.7%
655
  37.1%
Other
60
   6.9%
51
   5.7%
111
   6.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 870 participants 895 participants 1765 participants
870
 100.0%
895
 100.0%
1765
 100.0%
Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr   [1] 
Measure Type: Number
Unit of measure:  % Achieving MVPA Standard
Number Analyzed 870 participants 895 participants 1765 participants
Girls 15 16.2 15.5
Boys 31.8 35.6 33.2
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in Percentage of Children Meeting Physical Activity Policy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis based on the percentage of children (boys and girls, separately) achieving the 30 min MVPA standard
Arm/Group Title Immediate Intervention Delayed Intervention
Hide Arm/Group 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.
Overall Number of Participants Analyzed 1290 1345
Measure Type: Number
Unit of Measure: Percent children achieving MVPA standard
Year 1 - Boys Number Analyzed 477 participants 456 participants
35.9 29.0
Year 2 - Boys Number Analyzed 452 participants 443 participants
44.2 29.3
Year 3 - Boys Number Analyzed 485 participants 383 participants
47.0 31.3
Year 1- Girls Number Analyzed 418 participants 414 participants
19.1 13.1
Year 2 - Girls Number Analyzed 411 participants 421 participants
24.3 12.3
Year 3 - Girls Number Analyzed 409 participants 377 participants
21.6 19.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Intervention, Delayed Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.18 to 3.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Changes in Nutritional Quality of Snacks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Direct observation of the number of days per week a fruit or vegetable was served
Arm/Group Title Immediate Intervention Delayed Intervention
Hide Arm/Group 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.
Overall Number of Participants Analyzed NA NA
Overall Number of Units Analyzed
Type of Units Analyzed: Afterschool Programs
10 10
Mean (Standard Deviation)
Unit of Measure: Days/Week Fruit/Vegetables served
Year 1 0.6  (1.6) 0.7  (1.8)
Year 2 4.1  (1.9) 0.8  (1.8)
Year 3 4.3  (1.7) 1.7  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delayed Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.80
Confidence Interval (2-Sided) 95%
1.45 to 9.95
Estimation Comments [Not Specified]
Time Frame All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
Adverse Event Reporting Description All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
 
Arm/Group Title Delayed Intervention Immediate Intervention
Hide Arm/Group 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. 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).
All-Cause Mortality
Delayed Intervention Immediate Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Delayed Intervention Immediate Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Delayed Intervention Immediate Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael W Beets
Organization: University of South Carolina
Phone: 8037773003
EMail: beets@mailbox.sc.edu
Layout table for additonal information
Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT02144519    
Other Study ID Numbers: 1R01HL112787-01A1 ( U.S. NIH Grant/Contract )
1R01HL112787-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 13, 2014
First Posted: May 22, 2014
Results First Submitted: May 15, 2017
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018