Physical Activity and Nutrition Intervention in Afterschool Programs

• Sponsor: University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT02144519
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 2,635
• Arms: 2
• Duration (Months): 45

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity	Behavioral: Healthy Eating and Physical Activity	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2635 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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.; Other Names: HEPA
Experimental: 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.	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.; Other Names: HEPA

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Michael W Beets, PhD, University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Beets, Dr. Michael W. Beets, PhD, University of South Carolina
• ClinicalTrials.gov Identifier: NCT02144519
• Other Study ID Numbers: 1R01HL112787-01A1; 1R01HL112787-01A1
• First Posted: May 22, 2014
• Last Update Posted: Nov 16, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Pediatric Obesity

Study Results

Participant Flow

Pre-assignment Detail	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
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
STARTED	895	870
COMPLETED	895	870
NOT COMPLETED	0	0
Period Title: Year 1
STARTED	763	864
COMPLETED	763	864
NOT COMPLETED	0	0
Period Title: Year 1
STARTED	894	760
COMPLETED	894	760
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Delayed Intervention	Immediate Intervention	Total
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 Participants	870	895	1765
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.1 (1.8)	7.9 (1.8)	8.0 (1.8)
Sex: Female, Male (Count of Participants)
Female	414 47.6%	417 46.6%	831 47.1%
Male	456 52.4%	478 53.4%	934 52.9%
Race/Ethnicity, Customized (Count of 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 (Count of Participants)
United States	870 100%	895 100%	1765 100%
Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr (% Achieving MVPA Standard) [Number]
Girls	15	16.2	15.5
Boys	31.8	35.6	33.2

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	1290	1345
Year 1 - Boys	35.9	29.0
Year 2 - Boys	44.2	29.3
Year 3 - Boys	47.0	31.3
Year 1- Girls	19.1	13.1
Year 2 - Girls	24.3	12.3
Year 3 - Girls	21.6	19.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Immediate Intervention, Delayed Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.88
	Confidence Interval	(2-Sided) 95%; 1.18 to 3.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	NA	NA
Measure Afterschool Programs	10	10
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Delayed Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.80
	Confidence Interval	(2-Sided) 95%; 1.45 to 9.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Delayed Intervention		Immediate Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Delayed Intervention		Immediate Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

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.