Mobile Health Intervention for Smoking

(EQUIP Trial)

Overseen By Emma Brett, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Varenicline, Bupropion

Disqualifiers: Psychiatric disorders, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new mobile health tool, EQUIP, designed to help young adults quit using electronic nicotine delivery systems (ENDS) and cigarettes. Participants will receive either a 6-week smartphone-based intervention with optional nicotine replacement therapy (NRT) or standard care education on tobacco use. The trial targets young adults who regularly use ENDS and are interested in quitting or reducing their use. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially benefit from new strategies for quitting smoking.

Will I have to stop taking my current medications?

If you are currently using smoking cessation medications like Varenicline or Bupropion, you will need to stop taking them to participate in this trial.

What prior data suggests that this mHealth intervention is safe for young adults?

Research has shown that mobile health (mHealth) tools can help people quit smoking. However, studies do not provide specific safety details for the EQUIP mHealth tool, focusing instead on effectiveness and user engagement.

The EQUIP tool resembles other mHealth tools, such as smartphone apps or text messages, which are typically easy to use. These tools are non-invasive, as they do not involve medication or medical procedures, and aim to support and motivate users.

Participants in the study can request free nicotine replacement therapy (NRT), such as patches or gum. NRT is generally safe and commonly used to aid smoking cessation. Most individuals tolerate it well, though some may experience minor side effects like skin irritation from patches or mouth soreness from gum.

In summary, while specific safety data for EQUIP is lacking, mHealth tools and NRT are generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile health intervention for smoking because it leverages the convenience and accessibility of smartphones to support smoking cessation. Unlike traditional methods, which often rely on face-to-face counseling or scheduled group sessions, this approach offers a 6-week program of personalized mHealth messages that users can access anytime, anywhere. Additionally, participants can request free nicotine replacement therapy (NRT) as needed, enhancing their chances of quitting successfully. This combination of tailored digital support and flexible NRT access makes it a promising new strategy for helping people quit smoking.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

This trial compares a mobile health (mHealth) intervention with standard care for smoking cessation. Studies have shown that mobile phones can aid in quitting smoking. Participants in the mHealth arm will receive a 6-week message-based intervention via smartphone, which research indicates can engage users and help them remain smoke-free for at least a week. Additionally, users often feel positive about quitting and find these tools helpful. Overall, mobile health tools are considered a promising method to help young adults quit smoking. Meanwhile, participants in the standard care arm will receive a brief overview of electronic nicotine delivery systems and tobacco education, with the option to request nicotine replacement therapy. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-26 who use electronic cigarettes regularly and are interested in quitting or reducing their usage. They must be able to understand English, give informed consent, and not have a major psychiatric disorder or severe substance abuse issue. Women cannot be pregnant or breastfeeding, and participants should not currently be on smoking cessation meds or have had adverse reactions to nicotine replacement therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week mHealth message-based intervention through their smartphone, with the option of requesting free nicotine replacement therapy (NRT)

6 weeks

Remote interaction via smartphone

Follow-up

Participants are monitored for ENDS cessation and frequency of use, confirmed via a mailed saliva cotinine test

6 weeks

1 remote follow-up interaction

What Are the Treatments Tested in This Trial?

Interventions

• EQUIP
• Standard Care

Trial Overview The study is testing a new mobile health intervention called EQUIP designed to help young adults quit using electronic cigarettes compared with standard care practices. It's an initial pilot study that will translate effective smoking cessation strategies into a mobile format for this demographic.

How Is the Trial Designed?

Group I: mobile health (mHealth) Experimental Treatment 1 Intervention

Participants in this arm will receive a 6-week mHealth message based intervention through their smartphone. They will also have the option of requesting free nicotine replacement therapy (NRT) throughout the treatment period.

Group II: Standard care Active Control 1 Intervention

Participants in this arm will receive a 5-10 minute walk-through of electronic nicotine delivery system (ENDS) and tobacco education and skills based on the most recent evidence. They will also have the options of requesting a sample of NRT.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

This pilot study aims to evaluate the effectiveness of a commercially available smartphone app for tobacco cessation among young adults aged 18-30 who smoke more than 5 cigarettes a day, comparing it to usual care in a hospital setting.

The study will focus on feasibility metrics such as recruitment, retention, and adherence to the app, which will inform future larger trials on the effectiveness and cost-effectiveness of mobile interventions for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. Chu, KH., Escobar-Viera, CG., Matheny, SJ., et al.[2020]

Among 311,567 users of the iCoach app for smoking cessation, 26,785 steady users were identified, with more intensive app use linked to higher rates of smoking cessation, improved quitting stages, and increased self-efficacy over time.

The most significant improvements in smoking-related outcomes were observed within the first 3 months of app use, particularly among older users and women, who were more likely to engage with the app intensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study. Mansour, MB., Busschers, WB., Crone, MR., et al.[2023]

This systematic review aims to evaluate the effectiveness of mobile health (mHealth) interventions for smoking cessation by analyzing randomized controlled trials, which will help identify how to improve the design of these interventions.

The review will use a random-effects meta-analysis to summarize the effectiveness of mHealth interventions, focusing on self-reported smoking abstinence and service uptake, providing a comprehensive understanding of how mobile phone-based strategies can support smokers in quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying effective components for mobile health behaviour change interventions for smoking cessation and service uptake: protocol of a systematic review and planned meta-analysis. Kingkaew, P., Glidewell, L., Walwyn, R., et al.[2020]

In a study involving 2806 adult smokers, the e-Tabac Info Service (e-TIS) app did not show a significant difference in smoking cessation rates compared to current practices, with 7-day point prevalence abstinence rates of 12.6% for the app and 13.7% for the control group at 6 months.

However, participants who engaged more with the app (completing at least eight activities) had a higher cessation rate of 17.6% compared to 12.9% in the control group, suggesting that higher engagement with the app may enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. Affret, A., Luc, A., Baumann, C., et al.[2021]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

In a randomized controlled trial with 188 smokers, the Pivot smoking cessation program showed significantly higher engagement (mean app openings) compared to the QuitGuide app, indicating better user interaction with the program.

Pivot also demonstrated superior biovalidated cessation rates at 12 weeks (29% vs. 13%) and 26 weeks (21% vs. 10%) compared to QuitGuide, suggesting it is a more effective mobile solution for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. Marler, JD., Fujii, CA., Utley, MT., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10510452/

Mobile Phone–Based Interventions for Smoking Cessation ... Mobile phone–based cessation interventions have emerged as a promising alternative for smoking cessation, while evidence of the efficacy of mobile phone–based ...

2. withpower.com withpower.com/trial/phase-smoking-cigarette-4-2024-d9fd8

Mobile Health Intervention for Smoking (EQUIP Trial) This pilot study aims to evaluate the effectiveness of a commercially available smartphone app for tobacco cessation among young adults aged 18-30 who smoke ...

3. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000435

Comparative effectiveness of mobile health smoking ... The primary outcome is 7-day point prevalence of smoking abstinence at 6 months. Secondary outcomes are: 12-month smoking abstinence, and patient satisfaction ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127979/

Effectiveness of Digital Intervention for Tobacco Cessation ... The study reported high follow-up rates among participants using smartphone applications for smoking cessation. The retention rates were 87%, 90 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732762/

Outcomes of a Comprehensive Mobile Smoking Cessation ... At 3 months, Average Treatment Effects weighted abstinence rates were 4.2% for those who did not use the web-based community, 15.1% for those ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9944159/

“Appagalo” a Customized Mobile Health Intervention (mHealth ... The “Appagalo” app is an effective tool to support smoking cessation in young women. It is a simple mHealth alternative for smoking cessation.

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00589-8/fulltext

Efficacy of e-health interventions for smoking cessation ... The meta-analysis revealed that compared to traditional smoking cessation interventions, e-health interventions can increase point quit rates.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06292130

Health-Kit Enabled Mobile App for Tobacco Cessation It will be the primary outcome as it is appropriate for all smokers (ready to quit or not) and is highly correlated with interest in quitting (r=0.59). It is ...