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

Trial Summary

What is the purpose of this trial?

Electronic Nicotine Delivery Systems (ENDS) use remains prevalent among young adults, and many have high interest in quitting, yet research on effective intervention is lacking. A mobile health (mHealth) intervention that translates effective smoking cessation materials and pharmacotherapy may be a promising avenue for intervention. The initial phase of the proposed study uses a pilot study to evaluate a novel mHealth intervention for young adult ENDS and dual product (ENDS and combustible cigarette) users.

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 data supports the effectiveness of the treatment EQUIP, Standard Care in the Mobile Health Intervention for Smoking trial?

Research shows that mobile health interventions, which use mobile phones to help people quit smoking, can be effective. These interventions often provide personalized support and adapt to the user's needs, which can improve their chances of quitting smoking. ^{1 2 3 4 5}

Is the mobile health intervention for smoking generally safe for humans?

The research articles do not provide specific safety data for the mobile health intervention for smoking, but they focus on the effectiveness and engagement of smartphone apps for smoking cessation. ^{6 7 8 9 10}

How is the EQUIP treatment for smoking different from other treatments?

The EQUIP treatment is unique because it uses a mobile health (mHealth) approach, which involves mobile devices and applications to provide counseling and motivation for smoking cessation. This method is different from traditional treatments as it leverages technology to deliver personalized support and potentially increase engagement and effectiveness. ^{1 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2020]

2. Greece pubmed.ncbi.nlm.nih.gov

Effect of mobile interventions with nicotine replacement therapy sampling on long-term smoking cessation in community smokers: A pragmatic randomized clinical trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Interactive mobile system for smoking cessation. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

What Do People Want in a Smoking Cessation App? An Analysis of User Reviews and App Quality. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Smoking cessation with smartphone applications (SWAPP): study protocol for a randomized controlled trial. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Time-varying model of engagement with digital self reporting: Evidence from smoking cessation longitudinal studies. [2023]

10. Canada 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. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial testing a video-text tobacco cessation intervention among economically disadvantaged African American adults. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Black Smokers' Preferences for Features of a Smoking Cessation App: Qualitative Study. [2023]