NCT06864468

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Aug 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Aug 2025May 2027

First Submitted

Initial submission to the registry

February 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 26, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

February 25, 2025

Last Update Submit

November 17, 2025

Conditions

Obesity PreventionSchool Wellness Policy

Keywords

school-basedobesity preventionAmerican Indian children and youthschool wellness policy

Outcome Measures

Primary Outcomes (5)

  • Body Mass Index

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

    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

    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.

    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.

    From enrollment to the end of the intervention at 9 months

  • Health promotion survey

    Survey measuring healthy lifestyle behaviors

    From enrollment to the end of the intervention at 9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Health promotion curricula includes

Behavioral: Health promotion curricula

Control group

NO INTERVENTION

No intervention, usual day to day activities

Interventions

Health promotion curriculaBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

NOT YET RECRUITING

Northern Arizona University

Flagstaff, Arizona, 86011, United States

NOT YET RECRUITING

Northern Arizona University

Flagstaff, Arizona, 86011, United States

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

Central Study Contacts

Regina S Eddie, PhD

CONTACT

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

Velia L Nuno, PhD

CONTACT

520-626-3525vleybas@arizona.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Co-principal investigator

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 7, 2025

Study Start

August 26, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)