Obesity, Childhood
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERSummer activity program
Children receive a summer scorecard to facilitate access to local facilities for exercise.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Northern Arizona University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Children who are enrolled in one of the 4 high-risk schools in 2nd through 5th grade, whose parents/legal guardians provide consent and provide assent.
Exclusion criteria
* Children who are not enrolled in the selected schools, or whose parents/legal guardians do not provide consent, or whom do not provide assent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index Percentile Score Change at 10 Weeks | Measured at baseline and 10-weeks after baseline | 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. |
| Overweight Participants Body Mass Index Percentile Score Change | Baseline to 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index Percentile Score Change at 1 Year | Measured 1-year after baseline | 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. |
| Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks | Measured at baseline and at 10-weeks (after summer program) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| 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. | 130 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 22 |
| Overall Study | Unable to retrieve ID from school | 0 | 2 |
Baseline characteristics
| Characteristic | Immediate Intervention | Delayed Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 92 Participants | 130 Participants | 222 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.80 years STANDARD_DEVIATION 1.86 | 9.29 years STANDARD_DEVIATION 1.61 | 9.09 years STANDARD_DEVIATION 1.73 |
| Baseline BMI% | 59.53 Percentile STANDARD_DEVIATION 30.08 | 66.23 Percentile STANDARD_DEVIATION 32.02 | 63.43 Percentile STANDARD_DEVIATION 31.32 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian/Alaskan Native | 25 Participants | 47 Participants | 72 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 42 Participants | 42 Participants | 84 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian/Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Two or more | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 15 Participants | 40 Participants | 55 Participants |
| Region of Enrollment United States | 92 participants | 130 participants | 222 participants |
| Sex: Female, Male Female | 56 Participants | 57 Participants | 113 Participants |
| Sex: Female, Male Male | 36 Participants | 73 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 130 | 0 / 92 | 0 / 130 |
| other Total, other adverse events | 0 / 92 | 0 / 130 | 0 / 92 | 0 / 130 |
| serious Total, serious adverse events | 0 / 92 | 0 / 130 | 0 / 92 | 0 / 130 |
Outcome results
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.
Time frame: Measured at baseline and 10-weeks after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention | Body Mass Index Percentile Score Change at 10 Weeks | 0.307 Percentile | Standard Deviation 0.967 |
| Delayed Intervention | Body Mass Index Percentile Score Change at 10 Weeks | 1.755 Percentile | Standard Deviation 1.56 |
p-value: 0.24895% CI: [-0.793, 3.067]Regression, Linear
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.
Time frame: Baseline to 10 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention | Overweight Participants Body Mass Index Percentile Score Change | -2.632 Percentile | Standard Error 1.594 |
| Delayed Intervention | Overweight Participants Body Mass Index Percentile Score Change | -3.444 Percentile | Standard Error 1.836 |
p-value: 0.01895% CI: [-5.806, -0.541]Regression, Linear
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.
Time frame: Measured 1-year after baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention | Body Mass Index Percentile Score Change at 1 Year | 0.363 Percentile | Standard Error 1.676 |
p-value: 0.82995% CI: [-2.922, 3.648]Regression, Linear
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.
Time frame: Measured at baseline and at 10-weeks (after summer program)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention | Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks | 0.238 score on a scale | Standard Error 0.222 |
| Delayed Intervention | Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks | 0.311 score on a scale | Standard Error 0.154 |
p-value: 0.02695% CI: [0.034, 0.534]Regression, Linear