Clinical trial NCT03595332: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-07-23
Enrollment: 222
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Body Mass Index Percentile Score Change at 10 Weeks
timeFrame: Measured at baseline and 10-weeks after baseline
measure: Overweight Participants Body Mass Index Percentile Score Change
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Body Mass Index Percentile Score Change at 1 Year
timeFrame: Measured 1-year after baseline
measure: Change in Intention to Engage in Physical Activity From Baseline to 10 Weeks
timeFrame: Measured at baseline and at 10-weeks (after summer program)
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Fit kids of Arizona
state: Arizona
Study officials:
References:
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.
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.