Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths

NCT05037656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2026-05-05

No results posted yet for this study

Summary

The people of the U.S. Affiliated Pacific Islands (USAPI) face higher cancer incidence, especially lung/bronchia and head-and-neck cancer, and poorer cancer outcomes, compared with the U.S. nationally. This may partly be driven by the high rates of cigarette smoking and betel (areca) nut use in the USAPI. Previous data suggest that that adolescents on Guam, as young as middle school students report markedly higher e-cigarette and tobacco product use prevalence in the USAPI compared with the USAPI nationally. Guam youths are also at risk for the use of betel nuts. Yet, currently there are no tobacco product/areca nut use prevention programs that have been developed for and tested specifically USAPI adolescents. The proposed study will develop a school-based substance use prevention curriculum for e-cigarette, tobacco product, and areca nut use prevention among Guam youths. The curriculum will use lessons incorporating innovative videos and culturally grounded activities.

The study's specific aims are:

1. To develop a school-based curriculum for e-cigarette, tobacco product (i.e., cigarette, smokeless tobacco), and betel nut use prevention among middle school students in Guam.
2. Test the efficacy of the school-based curriculum in a randomized controlled trial.

Conditions

  • Tobacco Smoking
  • Vaping
  • Tobacco Chewing

Interventions

BEHAVIORAL

School-based curriculum

Participants will be randomized, at the school level, to receive either the e-cigarette/tobacco/areca nut use prevention curriculum or the standard of care (i.e., control). The curriculum will be implemented using 5 intensive in-class lessons over the span of 6 weeks. All sessions of the curriculum follow the same basic format: a) an introduction and/or review of the past lesson, b) a cultural wall activity, c) a video, d) 1-2 interactive activities, and e) a wrap-up activity. Lessons are designed such as to help improve knowledge about drugs and correct cognitive misperceptions and to train on skills to resist normative social influence. Participants will complete identical survey questionnaires for assessments at 3 time-points: pretest (baseline, before implementing the intervention), immediate posttest (following the end of the intervention), and six-month follow-up. The surveys will be administered in the classroom, during regular school hours.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Hawaii Cancer Research Center

    collaborator OTHER
  • University of Guam

    lead OTHER

Principal Investigators

  • Francis Dalisay, PhD · University of Guam

  • Pallav Pohkrel, PhD · University of Hawaii Cancer Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2024-08-31
Completion
2025-08-31

Countries

  • Guam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037656 on ClinicalTrials.gov