AzTrials
AzTrials

Obesity PreventionNCT06864468

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

A study testing Health promotion curricula in people with Obesity Prevention and School Wellness Policy, run by Northern Arizona University at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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?… Read more about this study

Who is it for?
Ages 8 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Obesity Prevention, School Wellness Policy
What is being tested?
Health promotion curricula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
26 Aug 2025to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

-

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Regina S Eddie, PhD contact

928-523-5437

regina.eddie@nau.edu

Velia L Nuno, PhD contact

520-626-3525

vleybas@arizona.edu

United States3 sites, 3 recruiting
  • Northern Arizona University

    Flagstaff, Arizona, 86011

    Regina S Eddie, PhD, 928-523-5437, regina.eddie@nau.edu

    Velia L Nuno, PhD, 520-626-3525, vleybas@arizona.edu

    Not yet recruiting
  • Northern Arizona University

    Flagstaff, Arizona, 86011

    Regina S Eddie, PhD, 928-523-5437, regina.eddie@nau.edu

    Not yet recruiting
  • Northern Arizona University

    Flagstaff, Arizona, 86011

    Regina S Eddie, PhD, 928-606-2670, regina.eddie@nau.edu

    Velia L Nuno, PhD, 520-626-3525, vleybas@arizona.edu

    Recruiting

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Health promotion curricula
Keywords
school-based, obesity prevention, American Indian children and youth, school wellness policy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health promotion curriculaBehavioural

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

Study groups in NCT06864468
Study groupRoleWhat they receive
Intervention groupExperimentalHealth promotion curricula includes
Receives: Behavioral: Health promotion curricula
Control groupNo interventionNo intervention, usual day to day activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

    Determine height and weight measurements for BMI using calibrated Tanita SC-331S Body Composition Analyzer and SECA Stadiometer

    Measured: From enrollment to the end of the intervention at 9 months

  2. 24-hour dietary recalls

    Diet 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

    Measured: From enrollment to the end of the intervention at 9 months

  3. Veggie Meter

    The 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.

    Measured: From enrollment to the end of the intervention at 9 months

  4. Physical activity wrist acclerometer (ActiGraph)

    Participants will wear the device for 7 days and nights to capture moderate and vigorous physical activity and sleep.

    Measured: From enrollment to the end of the intervention at 9 months

  5. Health promotion survey

    Survey measuring healthy lifestyle behaviors

    Measured: From enrollment to the end of the intervention at 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start26 Aug 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864468
Sponsor's protocol ID
2235532-4
Other IDs
2U54CA143925-16
Status last verified
Nov 2025
First submitted
25 Feb 2025
Last updated
20 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Health promotion curricula in people with Obesity Prevention and School Wellness Policy, run by Northern Arizona University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Regina S Eddie, PhD (928-523-5437, regina.eddie@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: From enrollment to the end of the intervention at 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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