Addressing Health Disparities in Childhood Obesity, One Summer at a Time

Obesity, Childhood Clinical Trial

Official title:

Addressing Health Disparities in Childhood Obesity, One Summer at a Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595332
• Other study ID #: 1193689
• Secondary ID: U54MD012388
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: April 22, 2020

Study information

• Verified date: September 2022
• Source: Northern Arizona University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Summer activity program
Children receive a summer scorecard to facilitate access to local facilities for exercise.

Locations

Country	Name	City	State
United States	Fit kids of Arizona	Flagstaff	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Northern Arizona University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Erratum in: Am J Prev Med. 2007 May;32(5):455. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Measured at baseline and 10-weeks after baseline
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.	Baseline to 10 weeks
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.	Measured 1-year after baseline
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.	Measured at baseline and at 10-weeks (after summer program)