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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States3 sites, 3 recruiting
- Not yet 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
- 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
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.
- Conditions
- Obesity Prevention, School Wellness Policy
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Health promotion curricula includes Receives: Behavioral: Health promotion curricula |
| Control group | No intervention | No intervention, usual day to day activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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.
- First posted7 Mar 2025
- Study start26 Aug 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Regina Eddie, Northern Arizona University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A School-Based Partnership With Rural Tribal Schools for the Primary Prevention of Obesity Among American Indian Youth (P2)
- ClinicalTrials.gov ID
- NCT06864468
- Acronym / sponsor ID
- 2235532-4
- Conditions
- Obesity Prevention, School Wellness Policy
- Keywords
- school-based, obesity prevention, American Indian children and youth, school wellness policy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- University of Arizona, National Cancer Institute (NCI)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health promotion curriculaHealth promotion curricula includes |
| Control group | No intervention | –No intervention, usual day to day activities |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promotion curricula3-day summer camp and 9-month health promotion curriculum that focuses on physical activity and nutrition | Behavioural | Intervention group |
Primary outcome
Body Mass Index
Time frame: From enrollment to the end of the intervention at 9 months
Determine height and weight measurements for BMI using calibrated Tanita SC-331S Body Composition Analyzer and SECA Stadiometer
24-hour dietary recalls
Time frame: From enrollment to the end of the intervention at 9 months
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
Veggie Meter
Time frame: From enrollment to the end of the intervention at 9 months
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.
Physical activity wrist acclerometer (ActiGraph)
Time frame: From enrollment to the end of the intervention at 9 months
Participants will wear the device for 7 days and nights to capture moderate and vigorous physical activity and sleep.
Health promotion survey
Time frame: From enrollment to the end of the intervention at 9 months
Survey measuring healthy lifestyle behaviors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- BackgroundGachupin FC, Joe JR. American Indian youth: A residential camp program for Wellness. Journal of Health Disparities Research and Practice 2017; 10(4):152-163
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
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.