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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD012388 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Almost 50% of Native American and Hispanic children are overweight or obese by the 5th grade. Research has demonstrated that the 'obesity gap' facing minority students is largely due to summer weight gain. However, very few summer programs have been tested among these populations. To encourage summer physical activity, the CDC developed a program that partners with local businesses to provide children with a 'scorecard' of subsidized or free local activities. The program has not been tested among Hispanic or Native American children. This study aims to test the impact of the scorecard program on Body Mass Index percentile, physical activity, sedentary behavior, barriers to physical activity and self-efficacy.
Over 50% of Native American children are overweight or obese by 5th grade, with similar rates found among Hispanics. Native American children have been estimated to have 9 times the diabetes rates of non-Hispanic Whites, suggesting an impending public health crisis without action. Recent research has demonstrated that the 'obesity gap' facing minority students is largely due to summer weight gain, with rapid increases ages 7-11. However, statewide in Arizona, only 22% of children participate in summer activities, despite 65% of parents expressing interest. Thus, we know which populations are at highest risk, at what developmental age changes occur most rapidly and that interventions are most needed in the summer, but that this need is not being met. A modest amount of research has evaluated summer programming, but almost none among Native Americans/Hispanics.
In 2004, the CDC developed a 'Summer Scorecard' intervention, a partnership with local businesses to provide children with a 'scorecard' of subsidized or free local activities. The Summer Scorecard program has not been tested among Hispanic and Native American children. Therefore, the current study propose to assess the effectiveness of the VSS among children ages 7-11 in the 4 highest risk elementary schools in the study area utilizing a randomized design. Two schools will participate in the first summer, and the remaining two children will participate in the second summer. Primary outcomes include objectively measured participation, body composition (BMI percentile), physical activity, sedentary behavior, reported barriers to physical activity and self-efficacy using survey instruments previously developed and tested by the Centers for Disease Control and Prevention. It is hypothesized that children participating in the summer program will increase their physical activity, self-efficacy, reduce their reported barriers to physical activity. In addition, it is hypothesized that they will show reduction in BMI percentile score compared to averages in their school and the school district.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate intervention | Experimental | Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. |
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| Delayed intervention | Experimental | Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summer activity program | Other | Children receive a summer scorecard to facilitate access to local facilities for exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index Percentile Score Change at 10 Weeks | Body mass index (BMI) will be calculated as kg/m2 and BMI-percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. The percentile indicates value relative to reference populations for age and sex, with at or below 5th percentile indicating the child being underweight, between 5 and 85th percentile as having a healthy weight, 85th to 95th percentile as being overweight and 95th percentile and above indicative of having obesity. | Measured at baseline and 10-weeks after baseline |
| Overweight Participants Body Mass Index Percentile Score Change | Body mass index (BMI) will be calculated as kg/m2 and BMI percentile calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI percentiles are measures of relative weight adjusted for child age and sex. This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study. | Baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index Percentile Score Change at 1 Year | Body mass index (BMI) will be calculated as kg/m2 and BMI-Percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. | Measured 1-year after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fit kids of Arizona | Flagstaff | Arizona | 86004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17218189 | Background | Huhman ME, Potter LD, Duke JC, Judkins DR, Heitzler CD, Wong FL. Evaluation of a national physical activity intervention for children: VERB campaign, 2002-2004. Am J Prev Med. 2007 Jan;32(1):38-43. doi: 10.1016/j.amepre.2006.08.030. | |
| 16061581 | Background | Huhman M, Potter LD, Wong FL, Banspach SW, Duke JC, Heitzler CD. Effects of a mass media campaign to increase physical activity among children: year-1 results of the VERB campaign. Pediatrics. 2005 Aug;116(2):e277-84. doi: 10.1542/peds.2005-0043. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention | Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise. |
| FG001 | Delayed Intervention | Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention | Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise. |
| BG001 | Delayed Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Body Mass Index Percentile Score Change at 10 Weeks | Body mass index (BMI) will be calculated as kg/m2 and BMI-percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. The percentile indicates value relative to reference populations for age and sex, with at or below 5th percentile indicating the child being underweight, between 5 and 85th percentile as having a healthy weight, 85th to 95th percentile as being overweight and 95th percentile and above indicative of having obesity. | Posted | Mean | Standard Deviation | Percentile | Measured at baseline and 10-weeks after baseline |
|
1 year
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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 | Immediate Intervention: Immediate Group | Summer activity program: Children received the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children received a summer scorecard to facilitate access to local facilities for exercise. |
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Limitations include a specific setting in the Southwestern United States. Second, any dose-response analyses were reliant on self-report. Loss to follow-up, likely due to children moving schools, reduced the final sample from 222 to 186 with at least partial follow-up measures (178 completed). Finally, COVID-19 prevented collection of secondary outcome 1-year follow-up BMI Percentile (Apr 2020) for one group as the school district shut down (and remote for a year after reopening).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hendrik de Heer | Northern Arizona University | 9285231499 | dirk.deheer@nau.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2018 | Sep 14, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2022 | Sep 14, 2022 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2019 | Aug 20, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks |
During your free time on most days, how likely will you do physical activities? with Likert type 5-answer options (1,2,3,4 or 5) ranging from (1) "I will not be active" to (5) "For sure I will be active". The minimum score is 1, maximum score is 5. Higher scores mean greater intentions to engage in physical activity. |
| Measured at baseline and at 10-weeks (after summer program) |
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 | Number | participants |
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| Baseline BMI% | Mean | Standard Deviation | Percentile |
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| OG001 | Delayed Intervention | Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children receive a summer scorecard to facilitate access to local facilities for exercise. |
|
|
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| Primary | Overweight Participants Body Mass Index Percentile Score Change | Body mass index (BMI) will be calculated as kg/m2 and BMI percentile calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI percentiles are measures of relative weight adjusted for child age and sex. This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study. | This analysis includes only those children who were overweight by CDC standards (equal or greater to 85th percentile for age and sex), as they were the high-risk group of interest for the study. | Posted | Mean | Standard Error | Percentile | Baseline to 10 weeks |
|
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|
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| Secondary | Body Mass Index Percentile Score Change at 1 Year | Body mass index (BMI) will be calculated as kg/m2 and BMI-Percentile score calculated using the L, M, S parameters published by the Centre for Disease Control and Prevention. BMI Percentile-score are measures of relative weight adjusted for child age and sex. | The delayed intervention group 1-year BMI Percentile follow-up was not possible as all schools closed in March 2020 with no measurements allowed over the next year. Of the 76 children (of 92 total) in the immediate intervention group who completed any follow-up measurements, 64 completed 1-year measurements. | Posted | Mean | Standard Error | Percentile | Measured 1-year after baseline |
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| Secondary | Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks | During your free time on most days, how likely will you do physical activities? with Likert type 5-answer options (1,2,3,4 or 5) ranging from (1) "I will not be active" to (5) "For sure I will be active". The minimum score is 1, maximum score is 5. Higher scores mean greater intentions to engage in physical activity. | Posted | Mean | Standard Error | score on a scale | Measured at baseline and at 10-weeks (after summer program) |
|
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Immediate Intervention: Delayed Group | The Delayed intervention group did not receive any intervention during the first summer of the 2-year study. | 0 | 130 | 0 | 130 | 0 | 130 |
| EG002 | Delayed Intervention: Immediate Group | The Immediate intervention group did not receive any intervention during the second summer of the 2-year study. | 0 | 92 | 0 | 92 | 0 | 92 |
| EG003 | Delayed Intervention: Delayed Group | Summer activity program: Children received the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children received a summer scorecard to facilitate access to local facilities for exercise. | 0 | 130 | 0 | 130 | 0 | 130 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Analysis test whether for both groups combined, Baseline to 10-week change in reported intention of physical activity was significantly different from zero.