ENDS Prevention for E-Cigarette Use

Overseen By Scott K Okamoto, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: K-5th grade, 9th-12th grade

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop and test a prevention program, the ENDS Prevention Intervention, to help stop e-cigarette use among rural Hawaiian youth. The program includes classroom lessons, social media content, and print materials designed to engage and educate students about the risks of e-cigarettes. Researchers will compare this new program against the usual health curriculum taught in schools. Sixth to eighth-grade students attending public or public-charter schools on Hawaii Island are the ideal participants for this study. As an unphased trial, this study offers students a unique opportunity to contribute to important research that could shape future health education programs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for youth?

Research has shown that programs aimed at preventing or reducing e-cigarette use can be safe and effective. For example, one study found that programs helping people quit vaping increased the number of successful quitters over time. These programs often include social media campaigns and educational content, similar to the ENDS Prevention Intervention being tested.

Additionally, other studies have found that these programs are generally well-tolerated, meaning people usually don't experience negative side effects. They are designed to be engaging and supportive, focusing on education and behavior change rather than using medication or invasive procedures.

While specific data from past trials on the ENDS Prevention Intervention is not available, educational and media campaigns have succeeded in similar efforts before. This suggests that the intervention is likely safe, especially since it uses non-invasive methods like classroom lessons and media content. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENDS Prevention Intervention for e-cigarette use because it takes a comprehensive approach by combining a classroom curriculum, social media content, and a print media campaign. Unlike traditional health education, which typically relies on standard classroom lessons, this intervention actively engages students across multiple platforms, potentially increasing its effectiveness. By addressing e-cigarette use through varied and modern channels, this strategy aims to resonate more with youth, making it a promising alternative to conventional methods.

What evidence suggests that the ENDS Prevention Intervention is effective for preventing e-cigarette use among rural Hawaiian youth?

Research has shown that programs to prevent e-cigarette use among young people can be effective. One study found that these programs can reduce the number of new e-cigarette users. Another review demonstrated that clear prevention messages can change young people's knowledge and beliefs about e-cigarettes, potentially reducing their use. Additionally, programs that assist teens in quitting vaping have succeeded, increasing the likelihood they will remain vape-free. This trial will test the ENDS Prevention Intervention, which includes a modular classroom curriculum, social media content, and a print media campaign, to determine its effectiveness in reducing e-cigarette use among rural Hawaiian youth. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for rural Hawaiian youth, primarily Native Hawaiian, who are attending middle or intermediate schools on Hawai'i Island. It aims to prevent the use of electronic nicotine delivery systems (ENDS), commonly known as e-cigarettes.

Inclusion Criteria

I am a student in grades 6-8 at a public or charter school on Hawaii Island.

Exclusion Criteria

I am a student in K-5th or 9th-12th grade on Hawaii Island.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention and Intervention Development

Focus groups and surveys are conducted to develop and prioritize ENDS-related problem situations and create narrative scripts and classroom lessons.

3 years

Efficacy Trial

The ENDS prevention intervention is evaluated using a dynamic wait-listed control group design across participating schools.

2 years

Follow-up

Participants are monitored for the effectiveness of the intervention with follow-up evaluations at various intervals post-intervention.

Up to 15 months

What Are the Treatments Tested in This Trial?

Interventions

• ENDS Prevention Intervention

Trial Overview

The intervention being tested includes a classroom curriculum supported by short films and video clips that address situations increasing the risk for ENDS use. Additionally, a social and print media campaign will reinforce the prevention messages from these materials.

How Is the Trial Designed?

Group I: ENDS Prevention Intervention Experimental Treatment 1 Intervention

Participants will receive the ENDS Prevention Intervention consisting of (1) a modular classroom curriculum, (2) social media content, and (3) print media campaign.

Group II: Treatment-as-usual control Active Control 1 Intervention

Participants will receive treatment-as-usual, which consists of the standard health curriculum delivered in public schools.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

Published Research Related to This Trial

Electronic nicotine delivery systems (ENDS), like e-cigarettes, were introduced as a safer alternative for smokers, but their use has expanded to young people and non-smokers, raising concerns about unintended health risks.

The design and power of ENDS devices can significantly affect their safety, with higher power devices potentially being more hazardous, highlighting the need for ongoing research to understand the benefits and risks associated with these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clearing the Haze: What Do We Still Need to Learn about Electronic Nicotine Delivery Systems? Fucito, LM., Malinosky, H., Baldassarri, SR., et al.[2023]

Electronic nicotine delivery systems (ENDS), like e-cigarettes, have rapidly increased in use among both adults and youth, raising concerns about their potential to either help reduce smoking rates or inadvertently encourage tobacco use among non-smokers and former smokers.

The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) emphasize the need for more research on ENDS to understand their health impacts and recommend strict regulations, including childproof packaging and prohibiting youth-targeted marketing, to mitigate potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. Brandon, TH., Goniewicz, ML., Hanna, NH., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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Effective interventions to prevent youth vaping behaviours

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sciencedirect.com

sciencedirect.com/science/article/pii/S0749379723003896

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As a result, e-cigarettes are viewed by some as a potential harm reduction tool for those interested in quitting smoking TC. However, others are ...

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This systematic review evaluated the efficacy and safety of e-cigarettes in helping people who smoke to achieve abstinence at 24–26 and 52 weeks.