Implementation ResearchNCT05500235
Comparing Smartphone to In-person Training to Scale up a Tobacco Control Program for Teachers in India
A study testing Smart phone based training and In person training in people with Implementation Research and Tobacco Cessation, run by Harvard School of Public Health (HSPH) at 1 site in India.
Trial summary
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 versus a smartphone-based training model. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Implementation Research, Tobacco Cessation
- What is being tested?
- Smart phone based training and In person training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,718 participants
- Where
- 1 siteIndia
- Study dates
- 27 Jun 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All school personnel (teachers, principals, and non-teaching staff) employed in schools in both study arms
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaling up Tobacco Control in India: Comparing Smartphone to In-person Training for Implementing an Evidence-based Intervention to Reduce Tobacco Use Among Schoolteachers
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 versus a smartphone-based training model. Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which principals or their designees-known as the Program in Charge (PIC)-at schools in the Indian state of Madhya Pradesh (MP) will be trained in person or via smartphone to deliver TFT-TFS in their schools. Schools will be randomly assigned to each training arm, and investigators will compare program implementation (primary outcome) as well as tobacco use cessation (secondary outcome).
We report here the results for our secondary outcome (tobacco use cessation) among school personnel (principals, teachers, and non-teaching staff) in the participating schools from both arms who implemented TFT-TFS in their schools.
Read the detailed description
Tobacco-related deaths are rising rapidly in low- and middle-income countries (LMICs). India is the second-largest consumer of tobacco products in the world: 29% of the adult population uses smoked, smokeless, or both forms of tobacco, and around 1.2 million people die each year from tobacco-related causes. Reducing tobacco-related deaths in LMICs will require large-scale implementation of evidence-based interventions (EBIs) that promote tobacco control. Currently, the implementation of tobacco control EBIs in LMICs relies on in-person training, which has inherent logistical challenges that limit the ability to scale up these programs. New training models are needed to ensure tobacco control EBIs can be implemented broadly, rapidly, and at low cost, especially in rural and under-resourced areas where tobacco use is prevalent.
The long-term goal is to identify effective, low-resource strategies to promote the broad-based implementation of tobacco control EBIs in LMICs. In India, schoolteachers are respected community leaders and role models, and an important channel for promoting tobacco control in schools and society. Investigators previously demonstrated the effectiveness of the Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) program in a cluster-randomized study of schoolteachers in Bihar state, India. Tobacco use cessation rates were doubled among teachers in intervention schools compared to control schools, along with significant improvements in the adoption and implementation of tobacco control policies. As a critical next step in scaling up the TFT-TFS tobacco control EBI, investigators are focusing on expanding the training of those implementing the program in schools, i.e., school principals or their designees, known as the Program in Charge (PIC).
The investigators will compare two models of TFT-TFS training of PICs-in-person vs. smartphone-based-and the effect of each approach on TFT-TFS program implementation and effectiveness. India has the world's second-largest mobile phone user subscription base of 1.2 billion, with good penetration even in rural areas. The use of smartphones in educational settings is already pervasive in India, offering a readily available, low-cost strategy for expanding training for the TFT-TFS program. Training via smartphones can be delivered anytime and anywhere and allows flexibility and individualization of the learning experience through on-demand access to training content and virtual interactions among trainees. By delivering TFT-TFS training through smartphones, the program's potential reach can be multiplied over what can be achieved with in-person training.
Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which PICs of schools in the Indian state of Madhya Pradesh (MP) will be randomly assigned to receive in-person training or training via smartphone for the TFT-TFS program. Once trained, PICs in both groups will implement the TFT-TFS program within schools. Investigators will compare the training arms regarding the primary outcome of program implementation, as well as tobacco use cessation (secondary outcome).
- Conditions
- Implementation Research, Tobacco Cessation
- Being tested
- Smart phone based training, In person training
- Keywords
- implementation, training, teachers, India, tobacco
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart phone based trainingOther
The study team will acquaint the principal or designee - known as the program in charge (PIC) - to the Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program and the smartphone training app at an orientation session. PICs will receive six monthly trainings on smartphones, including brief animated videos followed by quizzes with feedback, school progress displays, and the ability to review the content as needed. PICs will implement TFT-TFS at monthly school meetings with teachers. TFT-TFS consists of four program components: (1) six group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration.
In person trainingOther
The principal or their designee - known as the program in charge (PIC) - will receive three face-to-face trainings, each 60-75 minutes and held at convenient locations. The study team will introduce PICs to the TFT-TFS program and teach them how to use paper-based materials to implement TFT-TFS in their schools. The trainings will encourage PICs to discuss successes and come up with solutions to overcome challenges. PICs will implement TFT-TFS at monthly school meetings with teachers. TFT-TFS consists of four program components: (1) 6 group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration.
| Study group | Role | What they receive |
|---|---|---|
| Smart phone based training | Experimental | Smartphone-based training for the principal or their designee - known as the program in charge (PIC) - to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India Receives: Other: Smart phone based training |
| In person training | Experimental | In person training for the principal or their designee - known as the program in charge (PIC) - to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India Receives: Other: In person training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Schools That Had Implemented TFT-TFS
Program implementation was defined as the successful implementation of all four TFT-TFS components within a school. We first assessed implementation of each individual component and then calculated the proportion of schools that had implemented all four components. Implementation was a dichotomous variable (i.e., successfully implemented vs. inadequately implemented). A school was coded as having successfully implemented the program if all criteria were met:
- Discussions with teachers addressed at least 3 of 6 TFT-TFS themes
- Cessation materials were distributed to all teachers
- At least 4 of 6 TFT-TFS wall posters were displayed
- The school's tobacco policy was posted each month Schools that did not meet these criteria were coded as having inadequate implementation.
NOTE: The unit of analysis for these implementation data was the school. Each participating school had one Program-in-Charge (the principal or a designee) who was responsible for implementing TFT-TFS in that school.
Measured: 6-7 months
Secondary outcomes (1)
Number of School Personnel Participants Who Quit Tobacco Use in Schools That Implemented the TFT-TFS Program, Across Both Study Arms
To determine the number of school personnel participants who quit using tobacco, all personnel (principals, teachers, and other non-teaching staff) present during post-implementation evaluation visits in both arms were invited to complete a self-administered smartphone survey. The survey collected self-reported tobacco use, including whether they had quit, and these measures were compared between the two arms.
Measured: Immediately following TFT-TFS program implementation (month 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start27 Jun 2023
- Primary completion21 Nov 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Implementation ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative effectiveness trial
- Masking
- None (open label)
- Enrolment
- 2,718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Healis-Sekhsaria Institute for Public Health, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eve Nagler, Harvard School of Public Health (HSPH)
- Investigators
- Eve Nagler, ScD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500235
- Sponsor's protocol ID
- IRB20-2157
- Other IDs
- R01CA248910-01A1
- Status last verified
- Nov 2025
- First submitted
- 11 Aug 2022
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Tobacco Control in India: Comparing Smartphone to In-person Training for Implementing an Evidence-based Intervention to Reduce Tobacco Use Among Schoolteachers
- ClinicalTrials.gov ID
- NCT05500235
- Acronym / sponsor ID
- IRB20-2157
- Conditions
- Implementation Research, Tobacco Cessation
- Keywords
- implementation, training, teachers, India, tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,718 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Healis-Sekhsaria Institute for Public Health, National Cancer Institute (NCI)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 versus a smartphone-based training model. Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which principals or their designees-known as the Program in Charge (PIC)-at schools in the Indian state of Madhya Pradesh (MP) will be trained in person or via smartphone to deliver TFT-TFS in their schools. Schools will be randomly assigned to each training arm, and investigators will compare program implementation (primary outcome) as well as tobacco use cessation (secondary outcome).
We report here the results for our secondary outcome (tobacco use cessation) among school personnel (principals, teachers, and non-teaching staff) in the participating schools from both arms who implemented TFT-TFS in their schools.
Detailed description
Tobacco-related deaths are rising rapidly in low- and middle-income countries (LMICs). India is the second-largest consumer of tobacco products in the world: 29% of the adult population uses smoked, smokeless, or both forms of tobacco, and around 1.2 million people die each year from tobacco-related causes. Reducing tobacco-related deaths in LMICs will require large-scale implementation of evidence-based interventions (EBIs) that promote tobacco control. Currently, the implementation of tobacco control EBIs in LMICs relies on in-person training, which has inherent logistical challenges that limit the ability to scale up these programs. New training models are needed to ensure tobacco control EBIs can be implemented broadly, rapidly, and at low cost, especially in rural and under-resourced areas where tobacco use is prevalent.
The long-term goal is to identify effective, low-resource strategies to promote the broad-based implementation of tobacco control EBIs in LMICs. In India, schoolteachers are respected community leaders and role models, and an important channel for promoting tobacco control in schools and society. Investigators previously demonstrated the effectiveness of the Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) program in a cluster-randomized study of schoolteachers in Bihar state, India. Tobacco use cessation rates were doubled among teachers in intervention schools compared to control schools, along with significant improvements in the adoption and implementation of tobacco control policies. As a critical next step in scaling up the TFT-TFS tobacco control EBI, investigators are focusing on expanding the training of those implementing the program in schools, i.e., school principals or their designees, known as the Program in Charge (PIC).
The investigators will compare two models of TFT-TFS training of PICs-in-person vs. smartphone-based-and the effect of each approach on TFT-TFS program implementation and effectiveness. India has the world's second-largest mobile phone user subscription base of 1.2 billion, with good penetration even in rural areas. The use of smartphones in educational settings is already pervasive in India, offering a readily available, low-cost strategy for expanding training for the TFT-TFS program. Training via smartphones can be delivered anytime and anywhere and allows flexibility and individualization of the learning experience through on-demand access to training content and virtual interactions among trainees. By delivering TFT-TFS training through smartphones, the program's potential reach can be multiplied over what can be achieved with in-person training.
Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which PICs of schools in the Indian state of Madhya Pradesh (MP) will be randomly assigned to receive in-person training or training via smartphone for the TFT-TFS program. Once trained, PICs in both groups will implement the TFT-TFS program within schools. Investigators will compare the training arms regarding the primary outcome of program implementation, as well as tobacco use cessation (secondary outcome).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative effectiveness trial
| Arm | Type | Receives |
|---|---|---|
| Smart phone based training | Experimental | Other: Smart phone based trainingSmartphone-based training for the principal or their designee - known as the program in charge (PIC) - to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India |
| In person training | Experimental | Other: In person trainingIn person training for the principal or their designee - known as the program in charge (PIC) - to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All school personnel (teachers, principals, and non-teaching staff) employed in schools in both study arms
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart phone based trainingThe study team will acquaint the principal or designee - known as the program in charge (PIC) - to the Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program and the smartphone training app at an orientation session. PICs will receive six monthly trainings on smartphones, including brief animated videos followed by quizzes with feedback, school progress displays, and the ability to review the content as needed. PICs will implement TFT-TFS at monthly school meetings with teachers. TFT-TFS consists of four program components: (1) six group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration. | Other | Smart phone based training |
| In person trainingThe principal or their designee - known as the program in charge (PIC) - will receive three face-to-face trainings, each 60-75 minutes and held at convenient locations. The study team will introduce PICs to the TFT-TFS program and teach them how to use paper-based materials to implement TFT-TFS in their schools. The trainings will encourage PICs to discuss successes and come up with solutions to overcome challenges. PICs will implement TFT-TFS at monthly school meetings with teachers. TFT-TFS consists of four program components: (1) 6 group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration. | Other | In person training |
Primary outcome
Proportion of Schools That Had Implemented TFT-TFS
Time frame: 6-7 months
Program implementation was defined as the successful implementation of all four TFT-TFS components within a school. We first assessed implementation of each individual component and then calculated the proportion of schools that had implemented all four components. Implementation was a dichotomous variable (i.e., successfully implemented vs. inadequately implemented). A school was coded as having successfully implemented the program if all criteria were met: * Discussions with teachers addressed at least 3 of 6 TFT-TFS themes * Cessation materials were distributed to all teachers * At least 4 of 6 TFT-TFS wall posters were displayed * The school's tobacco policy was posted each month Schools that did not meet these criteria were coded as having inadequate implementation. NOTE: The unit of analysis for these implementation data was the school. Each participating school had one Program-in-Charge (the principal or a designee) who was responsible for implementing TFT-TFS in that school.
1 secondary outcome
Number of School Personnel Participants Who Quit Tobacco Use in Schools That Implemented the TFT-TFS Program, Across Both Study Arms
Time frame: Immediately following TFT-TFS program implementation (month 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve Nagler, ScD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart phone based training and In person training in people with Implementation Research and Tobacco Cessation, run by Harvard School of Public Health (HSPH) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Schools That Had Implemented TFT-TFS (time frame: 6-7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.