Smartphone vs In-Person Training for Quitting Smoking

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

2040 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to compare the implementation and effectiveness of the Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) program when delivered through in-person training vs. a smartphone-based training model. Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which headmasters at schools in the Indian state of Madhya Pradesh (MP) will be trained in person or via a smartphone to deliver TFT-TFS in their schools. Schools will be randomly assigned to each training arm, and investigators will compare program effectiveness (tobacco use cessation), implementation outcomes, and program cost and reach.

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 data supports the effectiveness of smartphone-based training for quitting smoking?

Research shows that smartphone apps can help people quit smoking by providing real-time, personalized support and increasing access to smoking cessation resources. These apps can be especially helpful for those who might try to quit on their own without much success. ^{1 2 3 4 5}

Is smartphone-based training for quitting smoking safe for humans?

The research does not provide specific safety data for smartphone-based training for quitting smoking, but these programs are generally considered safe as they primarily involve behavioral support and do not involve physical interventions. ^{5 6 7 8 9}

How does smartphone-based training for quitting smoking differ from other treatments?

Smartphone-based training for quitting smoking is unique because it leverages mobile apps to provide support and motivation, allowing users to access resources and potentially connect with healthcare professionals anytime and anywhere. This approach contrasts with traditional in-person training, which requires scheduled sessions and face-to-face interaction. ^{6 10 11 12 13}

Research Team

Eve Nagler, ScD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England 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. [2020]

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

Smartphone Smoking Cessation Application (SSC App) trial: a multicountry double-blind automated randomised controlled trial of a smoking cessation decision-aid 'app'. [2019]

5. Canada 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. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. [2023]

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

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

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

Population-level effects of automated smoking cessation help programs: a randomized controlled trial. [2022]

9. 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]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. [2022]

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

Smart devices and a future of hybrid tobacco cessation programs. [2017]

12. Greece pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Apps for Smoking Cessation: A Review. [2020]

13. Netherlands pubmed.ncbi.nlm.nih.gov

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