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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL112787-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | 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). |
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| Delayed Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Eating and Physical Activity | Behavioral | Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Programs that:
Exclusion Criteria:
Children that:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W Beets, PhD | University of South Carolina | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27397608 | Derived | Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Bottai M, Chandler J, Brazendale K, Beighle A. Physical activity outcomes in afterschool programs: A group randomized controlled trial. Prev Med. 2016 Sep;90:207-15. doi: 10.1016/j.ypmed.2016.07.002. Epub 2016 Jul 7. | |
| 26158679 | Derived | Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Freedman D, Hutto B, Moore JB, Beighle A. Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs. Am J Health Promot. 2016 Sep;30(7):521-31. doi: 10.4278/ajhp.141001-QUAN-486. Epub 2016 Jun 17. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
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| Year 2 |
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| Year 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis based on the percentage of children (boys and girls, separately) achieving the 30 min MVPA standard | Posted | Number | Percent children achieving MVPA standard | Spring of Year 1, Year 2, and Year 3 |
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael W Beets | University of South Carolina | 8037773003 | beets@mailbox.sc.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 25998921 | Derived | Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Beighle A. Making policy practice in afterschool programs: a randomized controlled trial on physical activity changes. Am J Prev Med. 2015 Jun;48(6):694-706. doi: 10.1016/j.amepre.2015.01.012. |
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| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Percentage of Achieving 30min Moderate-to-Vigorous Physical Activity (MVPA) Standard via acceleromtr | 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. | Number | % Achieving MVPA Standard |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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). |
| OG001 | 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. |
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| 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) | Direct observation of the number of days per week a fruit or vegetable was served | Posted | Mean | Standard Deviation | Days/Week Fruit/Vegetables served | Spring of Year 1, Year 2, and Year 3 | Afterschool Programs | Afterschool Programs |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Year 3 |
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