Tobacco Use CessationNCT05346991
Disseminating an Evidence-based Tobacco Control Intervention for School Teachers in India
A study testing Tobacco Free Teachers, Tobacco Free Society program in people with Tobacco Use Cessation, run by Glorian Sorensen at 2 sites in 2 countries.
Trial summary
Disseminating an evidence-based tobacco control intervention for School Teachers Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Tobacco Free Teachers, Tobacco Free Society program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,102 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All teachers and principals employed in intervention and control schools
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Disseminating an evidence-based tobacco control intervention for School Teachers
Read the detailed description
There is a profound need for evidence-based interventions that promote tobacco control on a large scale, particularly in low- and middle-income countries. In India in 2010 alone, tobacco use accounted for over one million deaths. The overall goal of this study is to identify effective strategies for broad-based implementation of evidence-based tobacco control interventions that can be embedded in existing organizational infrastructures and accommodate the realities of low-resource settings. This study builds on an intervention for school teachers, called the Tobacco-Free Teachers/Tobacco-Free Society (TFT-TFS) program, shown to be efficacious in increasing tobacco use cessation and tobacco policy implementation in a cluster randomized controlled trial in the Bihar School Teachers' Study (BSTS). Teachers in India are an important channel for promoting tobacco control, given their roles as community leaders and role models. The next logical step in this research is to develop the knowledge, products and processes needed to take this intervention to scale and disseminate it through readily accessible and sustainable channels. Investigators will test an implementation model for building capacity within education departments to support and deliver this program within schools, using the existing infrastructure for curriculum training in state education departments. Within each state in India, schools are organized within clusters, and cluster coordinators are responsible for directly training principals about curriculum issues. The investigators will build the capacity of cluster coordinators to train and support principals in implementing the TFT-TFS program in their schools. The central research question of this study is: Will this evidence-based intervention be successfully adopted, implemented, and sustained through existing channels using this implementation process? The specific aims are to: (1) determine the extent to which this implementation model meets acceptable rates of program adoption, implementation, reach and maintenance of the TFT-TFS program among schools in the Indian state of Bihar; (2) determine program effectiveness in increasing tobacco use cessation and implementation of tobacco control policies in schools; (3) determine the feasibility of building the capacity of cluster coordinators to train and support principals in program implementation and maintenance in schools, and for the Department of Education to sustain the program; and (4) determine the direct financial costs of program implementation and maintenance. This study uses a non-inferiority design to test the primary hypothesis that program adoption, implementation, and reach will not be inferior to the high standards demonstrated in BSTS; and assesses program effectiveness in improving tobacco use cessation and increasing policy implementation using a cluster randomized design. This research is innovative because it systematically examines the process of scaling up one of the first evidence-based approaches to tobacco use cessation among adults in India. This study is significant because it is expected to improve understanding of implementation processes needed for taking evidence-based interventions to scale.
- Conditions
- Tobacco Use Cessation
- Being tested
- Tobacco Free Teachers, Tobacco Free Society program
- 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.
Tobacco Free Teachers, Tobacco Free Society programOther
The Tobacco Free Teachers, Tobacco Free Society (TFT-TFS) program provides teachers with the knowledge and skills to quit tobacco use, or to help someone else quit; it also helps schools comply with national tobacco control policies. School principals implement four TFT-TFS program components with teachers in their schools during school hours across an academic year (August-April):
- Adopting a school tobacco control policy
- Providing cessation support (e.g. distribution of self-help quit booklets and referrals to government cessation resources)
- Conducting monthly group discussions with teachers about tobacco
- Hanging six thematic posters in the school
With the goal of establishing a tobacco-free school environment, the program incorporates six program themes: 1. Teachers as Role Models; 2. Health Effects of Tobacco; 3. Motivation to Quit-or Help Others to Quit; 4. Skills to Quit; 5. Dealing with Withdrawal; and 6. Maintenance and Celebration.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Implementation of the Tobacco-Free Teachers, Tobacco Free Society program in government schools in Bihar, India Receives: Other: Tobacco Free Teachers, Tobacco Free Society program |
| Control arm | No intervention | Delayed intervention - control arm schools receive the program after all data collection is complete |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use cessation among teachers
Self-administered Teacher's Survey completed by teachers. Using survey data, compute 7- and 30-day quit prevalence among teachers who reported using any tobacco in the last 9 months (the length of the academic year), and compare measures between intervention and control schools
Measured: Immediately post-intervention
Secondary outcomes (2)
School tobacco control policy implementation - School Observation
School Observation Checklist completed by an independent evaluator. Observations include the number of physical locations in the school and grounds with evidence of tobacco use (range 0 - 10, lower score indicates less evidence of tobacco use).
Measured: Immediately post-intervention
School tobacco control policy implementation - Teachers' Report
Self-administered Teacher's Survey completed by teachers. Using survey data, compute a composite score of five questions regarding presence of a tobacco policy and it's enforcement at the school (range 0-5, higher score indicates stricter policy.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jun 2018
- Primary completion30 Jun 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glorian Sorensen
- Sponsor type
- University, hospital or other
- Collaborators
- Healis-Sekhsaria Institute for Public Health
- Responsible party
- Sponsor-investigator, Glorian Sorensen, Harvard School of Public Health (HSPH)
- Investigators
- Glorian Sorensen, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346991
- Sponsor's protocol ID
- IRB16-1055
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagler EM, Pednekar M, Sinha DN, Stoddard AM, Narake S, Adhikari K, Jones L, Lando H, Vriniotis M, Gupta P, Sorensen G. Implementation of an evidence-based tobacco control intervention for school teachers in India: Evaluating the effects of a capacity-building strategy. Implement Res Pract. 2023 Mar 22;4:26334895231159428. doi: 10.1177/26334895231159428. eCollection 2023 Jan-Dec.
PubMed 37091538
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating an Evidence-based Tobacco Control Intervention for School Teachers in India
- ClinicalTrials.gov ID
- NCT05346991
- Acronym / sponsor ID
- IRB16-1055
- Conditions
- Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Glorian SorensenUniversity, hospital or other
- Collaborators
- Healis-Sekhsaria Institute for Public Health
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disseminating an evidence-based tobacco control intervention for School Teachers
Detailed description
There is a profound need for evidence-based interventions that promote tobacco control on a large scale, particularly in low- and middle-income countries. In India in 2010 alone, tobacco use accounted for over one million deaths. The overall goal of this study is to identify effective strategies for broad-based implementation of evidence-based tobacco control interventions that can be embedded in existing organizational infrastructures and accommodate the realities of low-resource settings. This study builds on an intervention for school teachers, called the Tobacco-Free Teachers/Tobacco-Free Society (TFT-TFS) program, shown to be efficacious in increasing tobacco use cessation and tobacco policy implementation in a cluster randomized controlled trial in the Bihar School Teachers' Study (BSTS). Teachers in India are an important channel for promoting tobacco control, given their roles as community leaders and role models. The next logical step in this research is to develop the knowledge, products and processes needed to take this intervention to scale and disseminate it through readily accessible and sustainable channels. Investigators will test an implementation model for building capacity within education departments to support and deliver this program within schools, using the existing infrastructure for curriculum training in state education departments. Within each state in India, schools are organized within clusters, and cluster coordinators are responsible for directly training principals about curriculum issues. The investigators will build the capacity of cluster coordinators to train and support principals in implementing the TFT-TFS program in their schools. The central research question of this study is: Will this evidence-based intervention be successfully adopted, implemented, and sustained through existing channels using this implementation process? The specific aims are to: (1) determine the extent to which this implementation model meets acceptable rates of program adoption, implementation, reach and maintenance of the TFT-TFS program among schools in the Indian state of Bihar; (2) determine program effectiveness in increasing tobacco use cessation and implementation of tobacco control policies in schools; (3) determine the feasibility of building the capacity of cluster coordinators to train and support principals in program implementation and maintenance in schools, and for the Department of Education to sustain the program; and (4) determine the direct financial costs of program implementation and maintenance. This study uses a non-inferiority design to test the primary hypothesis that program adoption, implementation, and reach will not be inferior to the high standards demonstrated in BSTS; and assesses program effectiveness in improving tobacco use cessation and increasing policy implementation using a cluster randomized design. This research is innovative because it systematically examines the process of scaling up one of the first evidence-based approaches to tobacco use cessation among adults in India. This study is significant because it is expected to improve understanding of implementation processes needed for taking evidence-based interventions to scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Tobacco Free Teachers, Tobacco Free Society programImplementation of the Tobacco-Free Teachers, Tobacco Free Society program in government schools in Bihar, India |
| Control arm | No intervention | –Delayed intervention - control arm schools receive the program after all data collection is complete |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All teachers and principals employed in intervention and control schools
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 |
|---|---|---|
| Tobacco Free Teachers, Tobacco Free Society programThe Tobacco Free Teachers, Tobacco Free Society (TFT-TFS) program provides teachers with the knowledge and skills to quit tobacco use, or to help someone else quit; it also helps schools comply with national tobacco control policies. School principals implement four TFT-TFS program components with teachers in their schools during school hours across an academic year (August-April): * Adopting a school tobacco control policy * Providing cessation support (e.g. distribution of self-help quit booklets and referrals to government cessation resources) * Conducting monthly group discussions with teachers about tobacco * Hanging six thematic posters in the school With the goal of establishing a tobacco-free school environment, the program incorporates six program themes: 1. Teachers as Role Models; 2. Health Effects of Tobacco; 3. Motivation to Quit-or Help Others to Quit; 4. Skills to Quit; 5. Dealing with Withdrawal; and 6. Maintenance and Celebration. | Other | Intervention arm |
Primary outcome
Tobacco use cessation among teachers
Time frame: Immediately post-intervention
Self-administered Teacher's Survey completed by teachers. Using survey data, compute 7- and 30-day quit prevalence among teachers who reported using any tobacco in the last 9 months (the length of the academic year), and compare measures between intervention and control schools
2 secondary outcomes
School tobacco control policy implementation - School Observation
Time frame: Immediately post-intervention
School tobacco control policy implementation - Teachers' Report
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 37091538Nagler EM, Pednekar M, Sinha DN, Stoddard AM, Narake S, Adhikari K, Jones L, Lando H, Vriniotis M, Gupta P, Sorensen G. Implementation of an evidence-based tobacco control intervention for school teachers in India: Evaluating the effects of a capacity-building strategy. Implement Res Pract. 2023 Mar 22;4:26334895231159428. doi: 10.1177/26334895231159428. eCollection 2023 Jan-Dec.
- 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.
Glorian Sorensen, PhD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco Free Teachers, Tobacco Free Society program in people with Tobacco Use Cessation, run by Glorian Sorensen at 2 sites in 2 countries.
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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tobacco use cessation among teachers (time frame: Immediately post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346991, which also lists 1 linked publication.
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 26 Apr 2022.