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Primary Prevention of Obesity in American Indian Youth in Rural Tribal Schools

A School-Based Partnership With Rural Tribal Schools for the Primary Prevention of Obesity Among American Indian Youth (P2)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06864468
Enrollment
120
Registered
2025-03-07
Start date
2025-08-26
Completion date
2027-05-31
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Prevention, School Wellness Policy

Keywords

school-based, obesity prevention, American Indian children and youth, school wellness policy

Brief summary

The goal of this study is to learn if a culturally relevant health promotion curricula prevents obesity among 4th graders in rural tribal schools. The main questions it aims to answer are: 1) Does the health promotion curricula intervention increase diet and physical activity behaviors in 4th grade students? Researchers will compare 4th grade classes who will receive intervention at two intervention schools to 4th grades at two comparison schools who will not receive the intervention. All participants will have their skin carotenoids assessed using Veggie Meter, complete 24-hour diet recall via telephone, height and weight measured, body composition, answer two surveys about perceptions of their school environment practices and diet patterns at school, wear accelerometers for 7 days

Detailed description

High prevalence of obesity is a serious health concern among American Indian (AI) youth, placing them at disproportionate risk for adult obesity and obesity-driven metabolic diseases such as diabetes, cardiovascular disease, and cancer. Among individuals with diabetes, alarmingly, cancer has become the leading cause of death. This underscores the urgent need to address excess weight in AI youth to protect against obesity-related diseases and cancer. To date, a limited number of intervention studies have been developed to prevent obesity in AI youth with few studies that have used schools for implementation of nutrition and physical activity (PA) interventions. Of these studies none reported significant improvements in weight-related outcomes, but showed modest improvements in knowledge, attitude and behaviors among AI youth related to nutrition and PA. Notably these reviews reported on studies from the late 1990s to early and mid 2000s - a time period before the federal government took action through key federal legislation requiring schools and school districts to provide more healthy foods and promote physical activity. The Child Nutrition and WIC Reauthorization Act of 2004 was the first national policy to require all schools and school districts that receive federal funding under the National School Lunch Program (NSLP) to develop and implement school wellness policies (SWPs). In 2010, the Healthy-Hunger Free Kids Act strengthened nutrition standards to help schools offer healthier school meals and limit access to low nutrient food sources outside the school lunch program such through á la carte, classroom parties, fundraisers, and school events. Schools in rural tribal communities participate in the NSLP and are an opportune setting to implement obesity prevention measures through school policies, practices and supportive environments. To our knowledge, Dr. Eddie's early work in school-based research is the only published work that assessed school nutrition policies and practices in Navajo Nation schools after the updated school meal and 'competitive' food standards were set forth by the Healthy Hunger Free-Kids Act of 2010. A follow-up pilot research project, using a mixed methods approach, examined the broader school environment beyond nutrition including school wellness policies and practices related to student nutrition, physical activity, other wellness activities. Preliminary conclusions include the following: 1) schools need support to further develop and strengthen wellness policies; 2) strategies to reduce unhealthy snacks and beverages in classrooms, fundraising events are needed; 3) strategies to increase physical activity opportunities are needed; and 4) engaging parents, school boards, communities, and tribal government to support in school wellness efforts. The goal of P2 is to engage and partner with four primary (K-6) schools on Navajo Nation to support, develop and implement obesity prevention programming. The objectives are to implement an established health promotion curricula among 4th graders after completing formative research to strengthen SWPs at each school, to establish a baseline for each school. We will use a train-the-trainer approach to establish structured lessons and practices, as warranted, for physical education instructors and food service personnel, for example. The health promotion curricula for the students will include culturally tailored health education focused on nutrition and physical activity. We will build on our existing collaborative partnerships with these tribal communities and established relationships with the Navajo Nation tribal schools. We will engage key school personnel for the formative work to better understand current school capacities and resources. Our proposed outcomes will include increased knowledge among students about healthy lifestyle and stronger SWPs that increase opportunities to access fruits and vegetables, increase structured physical activity, and steps to sustain these beyond the 3-year grant period. We hypothesize that participation in our health promotion efforts will strengthen school-specific SWPs, including structured physical activity, and that 4th grade youth will increase their knowledge and exhibit improved behaviors for fruits and vegetables consumption and increased physical activity.

Interventions

BEHAVIORALHealth promotion curricula

3-day summer camp and 9-month health promotion curriculum that focuses on physical activity and nutrition

Sponsors

University of Arizona
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Northern Arizona University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Year 1 (2025-2026): * 4th-grade students at School A and School B will receive the intervention. * 4th-grade students at School C and School D will serve as the comparison group (no intervention). Year 2 (2026-2027): * 4th-grade students at School C and School D will receive the intervention. * 4th-grade students at School A and School B will not receive the intervention.

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

students enrolled in the 4th and 3rd grades at one of the participating schools, has parental consent, ability to attend baseline assessment, and the 3-day summer camp -

Exclusion criteria

any student not in either the 3rd or 4th grades, and youth who have not completed an application with any known allergies or limitations to physical activity will not be included \-

Design outcomes

Primary

MeasureTime frameDescription
Body Mass IndexFrom enrollment to the end of the intervention at 9 monthsDetermine height and weight measurements for BMI using calibrated Tanita SC-331S Body Composition Analyzer and SECA Stadiometer
24-hour dietary recallsFrom enrollment to the end of the intervention at 9 monthsDiet recalls will be conducted within a 2-week period (2 weekdays and 1 weekend day) using the Nutrition Data System for Research. Trained interviewers will administer the 24-hour recalls over the telephone
Veggie MeterFrom enrollment to the end of the intervention at 9 monthsThe veggie meter uses a low-energy blue light to quantify changes in skin carotenoid levels using resonance spectrosocopy. The pad of the index finger is scanned.
Physical activity wrist acclerometer (ActiGraph)From enrollment to the end of the intervention at 9 monthsParticipants will wear the device for 7 days and nights to capture moderate and vigorous physical activity and sleep.
Health promotion surveyFrom enrollment to the end of the intervention at 9 monthsSurvey measuring healthy lifestyle behaviors

Countries

United States

Contacts

Primary ContactRegina S Eddie, PhD
regina.eddie@nau.edu928-523-5437
Backup ContactVelia L Nuno, PhD
vleybas@arizona.edu520-626-3525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026