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

NCT ID: NCT06864468

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-26
• Study Completion Date: 2027-05-31

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.

Conditions

Obesity Prevention; School Wellness Policy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

Health promotion curricula includes

Group Type: EXPERIMENTAL

Health promotion curricula

Intervention Type: BEHAVIORAL

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

Control group

No intervention, usual day to day activities

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health promotion curricula

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Regina Eddie

Associate professor, Co-principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northern Arizona University

Flagstaff, Arizona, United States

Site Status: NOT_YET_RECRUITING

Northern Arizona University

Flagstaff, Arizona, United States

Site Status: NOT_YET_RECRUITING

Northern Arizona University

Flagstaff, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Regina S Eddie, PhD

Role: CONTACT

regina.eddie@nau.edu

928-523-5437

Velia L Nuno, PhD

Role: CONTACT

vleybas@arizona.edu

520-626-3525

Facility Contacts

Regina S Eddie, PhD

Role: primary

regina.eddie@nau.edu

928-523-5437

Velia L Nuno, PhD

Role: backup

vleybas@arizona.edu

520-626-3525

Regina S Eddie, PhD

Role: primary

regina.eddie@nau.edu

928-523-5437

Regina S Eddie, PhD

Role: primary

regina.eddie@nau.edu

928-606-2670

Velia L Nuno, PhD

Role: backup

vleybas@arizona.edu

520-626-3525

References

Gachupin FC, Joe JR. American Indian youth: A residential camp program for Wellness. Journal of Health Disparities Research and Practice 2017; 10(4):152-163

Reference Type: BACKGROUND

Other Identifiers

2U54CA143925-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2235532-4

Identifier Type: -

Identifier Source: org_study_id