Smartphone vs In-Person Training for Quitting Smoking

Not currently recruiting at 2 trial locations

Overseen By Smita Warke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard School of Public Health (HSPH)

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?

This trial aims to determine the most effective method for helping schools in Madhya Pradesh, India, implement a program to help people quit smoking. The study compares two training methods for school headmasters: in-person sessions and smartphone-based sessions. It evaluates each method's effectiveness in helping people stop using tobacco, ease of use, and cost. Teachers and principals currently working in schools in Madhya Pradesh are well-suited for this trial. As an unphased trial, it offers participants the chance to contribute to innovative educational methods for tobacco cessation.

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 these training methods are safe for implementation?

Research has shown that smartphone apps for quitting smoking have been evaluated for effectiveness. These apps are considered affordable tools, but there is insufficient information about their safety or the extent of supporting evidence. While these apps might aid smoking cessation, potential negative effects remain unclear.

In-person training to quit smoking has proven successful in helping individuals stop. Studies indicate that training and support significantly improve the chances of quitting. Limited information on negative side effects from in-person training suggests it is generally safe.

Both smartphone apps and in-person training are used to assist smoking cessation. While more research is needed to fully understand the safety of smartphone apps, in-person training is generally regarded as safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring two innovative methods to help people quit smoking by training school headmasters in Madhya Pradesh, India. One method uses smartphone-based training, making it accessible and scalable, especially in areas with limited resources. This digital approach allows for flexible learning and can reach a wider audience compared to traditional methods. On the other hand, in-person training offers a more hands-on, interactive experience which can be crucial for understanding and implementing the Tobacco Free Teachers-Tobacco Free Society program effectively. By comparing these two approaches, researchers hope to discover which method is more effective in creating a smoke-free environment in schools.

What evidence suggests that this trial's training methods could be effective for quitting smoking?

This trial will compare smartphone-based training with in-person training for quitting smoking. Research has shown that smartphone apps can aid smoking cessation, with studies finding that these apps can increase the chances of quitting. In-person programs are also effective; one study found that attendees of an in-person program were more successful at quitting than non-attendees. Both methods work, but the best choice depends on individual preference and available resources. Participants in this trial will be assigned to either the smartphone-based training or the in-person training arm to evaluate their effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Eve Nagler, ScD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for teachers and principals currently working in schools within the Indian state of Madhya Pradesh. There are no specific exclusion criteria, meaning all educators in this region can participate regardless of their smoking status or other factors.

Inclusion Criteria

All teachers and principals employed in schools in both study arms

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Headmasters receive training to implement the Tobacco-Free Teachers, Tobacco-Free Society program, either in-person or via smartphone

4-6 weeks

Training sessions (in-person or virtual)

Implementation

Headmasters implement the TFT-TFS program in their schools

8-12 weeks

Follow-up

Participants are monitored for program effectiveness and tobacco use cessation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• In person training
• Smart phone based training

Trial Overview The study is testing two methods to deliver a tobacco control program: one group receives training through a smartphone app, while another gets it face-to-face. The goal is to see which method helps more educators quit smoking and how well each approach works overall.

How Is the Trial Designed?

Group I: Smart phone based training Experimental Treatment 1 Intervention

Smartphone-based training for Headmasters to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India

Group II: In person training Experimental Treatment 1 Intervention

In person training for Headmasters to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India

Who Is Running the Clinical Trial?

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials

283

Recruited

17,030,000+

Healis-Sekhsaria Institute for Public Health

Collaborator

Trials

4

Recruited

11,000+

Published Research Related to This Trial

A study involving 181 participants found that most users rated the smoking cessation app QuitPal-m as very helpful, but daily usage declined over time, indicating a need for ongoing support to maintain engagement.

The effectiveness of the app was enhanced by supportive accountability from cessation counselors, particularly for smokers with low motivation to quit, highlighting the importance of addressing both personal barriers and technical issues to improve app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. Lepore, SJ., Collins, BN., Killam, HW., et al.[2023]

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

A hybrid intervention combining telephone counseling and text messaging was tested on 66 hospitalized smokers in Brazil, showing a higher rate of abstinence at 1-month (25.0% vs. 9.1%) and 3-month (31.8% vs. 9.1%) follow-ups compared to a standard care group.

Participants found the text messaging helpful (80.4% approval) and the counseling session appropriate in length (95.1% approval), indicating that this approach is not only effective but also well-received, making it a promising low-cost option for smoking cessation in middle- and lower-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experimental Feasibility Study of a Hybrid Telephone Counseling/Text Messaging Intervention for Post-Discharge Cessation Support Among Hospitalized Smokers in Brazil. Cruvinel, E., Richter, KP., Colugnati, F., et al.[2020]

A study of 252 smoking cessation apps for iPhone and 148 for Android revealed that popular apps generally have low adherence to U.S. Public Health Service guidelines, scoring an average of only 12.9 out of 42 on the Adherence Index.

None of the apps recommended calling a quitline, and only 4.1% suggested using approved medications, indicating a significant gap in evidence-based support for users trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. Abroms, LC., Lee Westmaas, J., Bontemps-Jones, J., et al.[2022]

Smartphone applications for smoking cessation have been shown to increase quit rates among smokers, particularly when users engage with features like audiovisual content, quit plans, and progress tracking.

While these apps can help reduce relapse rates, the effectiveness varies based on how well users adhere to the app's features, indicating that user engagement is crucial for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Apps for Smoking Cessation: A Review. Regmi, K., Kassim, N., Ahmad, N., et al.[2020]

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]

A smartphone app designed for smoking cessation effectively assessed real-time risk for smoking lapses and provided tailored messages, leading to greater reductions in smoking urges, stress, and cigarette availability among participants (N=59) over a 3-week period.

Messages specifically tailored to individual triggers, such as smoking urges and stress, were more effective in reducing those triggers compared to generic messages, suggesting that personalized interventions can enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. Hébert, ET., Stevens, EM., Frank, SG., et al.[2022]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11580340/

In-Person versus Virtual CEASE Smoking Cessation ... Our results clearly indicate that the in-person smoking cessation group was the most successful in helping participants quit smoking, with a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8654642/

Effectiveness of the Internet-Based Versus Face-to-Face ... Results suggest significantly higher tobacco quitting events in the internet intervention group than the control group at one month, three months, six months, ...

3. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Determinants-of-successful-smoking-cessation-in-outpatient-settings-A-comparative,208449,0,2.html

Determinants of successful smoking cessation in outpatient ... This study found that the free smoking cessation program has a significant reducing effect on nicotine dependence among smokers, but its impact ...

4. publications.ersnet.org publications.ersnet.org/content/errev/31/165/220063

Intensive versus short face-to-face smoking cessation ... In this meta-analysis, the chance of maintaining successful quitting is higher after attending intensive smoking cessation interventions compared with shorter ...

5. 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.

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

Outcomes of a Comprehensive Mobile Smoking Cessation ... Study outcomes focused on 4 areas: user engagement and retention, attitudes toward quitting, smoking behavior, and participant feedback.

7. openworks.mdanderson.org openworks.mdanderson.org/cgi/viewcontent.cgi?article=1007&context=aceqi

A Tobacco Treatment Training Program Expands the Number ... In 2023, Arkansas quit rates were 34% and increased when patients attended multiple counseling calls. Given the ever-changing landscape and ...

8. tobaccopreventioncessation.com tobaccopreventioncessation.com/Participation-in-a-workplace-smoking-cessation-program-nincentivized-by-lowering,118237,0,2.html

Participation in a workplace smoking cessation program ... In the LLUH BREATHE cohort, we found a very high rate of participation (72.7%; 95% CI: 69–77%) in workplace smoking cessation that was ...

9. truthinitiative.org truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats

Quitting Tobacco: Facts and Stats Providing sufficient training in quit-smoking treatments to health care providers can more than double a smoker's odds of successfully quitting.