RecruitingNot Applicable

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

United States120 participantsStarted 2025-08-26

Plain-language 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

Who can participate

Age range

8 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body Mass Index

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

24-hour dietary recalls

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

Veggie Meter

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

Physical activity wrist acclerometer (ActiGraph)

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

Health promotion survey

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

Trial details

NCT IDNCT06864468

SponsorNorthern Arizona University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Regina S Eddie, PhD

928-523-5437 regina.eddie@nau.edu

View on ClinicalTrials.gov More Obesity Prevention trials

Plain-language summary

Who can participate

Age range

8 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Body Mass Index

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

24-hour dietary recalls

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

Veggie Meter

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

Physical activity wrist acclerometer (ActiGraph)

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

Health promotion survey

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