Addressing Health Disparities in Childhood Obesity, One Summer at a Time
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Summer activity program
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
Eligibility Criteria
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.
Sites / Locations
- Fit kids of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate intervention
Delayed intervention
Arm Description
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study.
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03595332
First Posted
June 22, 2018
Last Updated
September 28, 2022
Sponsor
Northern Arizona University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03595332
Brief Title
Addressing Health Disparities in Childhood Obesity, One Summer at a Time
Official Title
Addressing Health Disparities in Childhood Obesity, One Summer at a Time
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Arizona University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate intervention
Arm Type
Experimental
Arm Description
Summer activity program: Children will receive the summer scorecard program during the first summer of the 2-year study.
Arm Title
Delayed intervention
Arm Type
Experimental
Arm Description
Summer activity program: Children will receive the summer scorecard program during the second summer of the 2-year study.
Intervention Type
Other
Intervention Name(s)
Summer activity program
Intervention Description
Children receive a summer scorecard to facilitate access to local facilities for exercise.
Primary Outcome Measure Information:
Title
Body Mass Index Percentile Score Change at 10 Weeks
Description
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
Title
Overweight Participants Body Mass Index Percentile Score Change
Description
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
Secondary Outcome Measure Information:
Title
Body Mass Index Percentile Score Change at 1 Year
Description
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
Title
Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Fit kids of Arizona
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17218189
Citation
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. Erratum In: Am J Prev Med. 2007 May;32(5):455.
Results Reference
background
PubMed Identifier
16061581
Citation
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.
Results Reference
background
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Addressing Health Disparities in Childhood Obesity, One Summer at a Time
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