Scaling up tobacco control in India: a protocol for a hybrid III cluster randomized trial comparing smartphone to in-person training to implement a tobacco control program for school teachers

Authors

  • Mangesh S. Pednekar Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India
  • Priyanka Ghosh Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India
  • Smita Warke Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA
  • Leah C. Jones Public Health Editor, Boston, MA, USA
  • Sameer Narake Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India
  • Glorian Sorensen Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA
  • Prakash C. Gupta Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India
  • Eve M. Nagler Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA

DOI:

https://doi.org/10.18203/2349-3259.ijct20261388

Keywords:

Tobacco control, Smartphones, Training, Schools, LMICs, India

Abstract

Background: Low-and middle-income countries (LMICs) face increasing tobacco-related deaths. India is second in global tobacco use, with 29% adult users. Logistical challenges with in-person training in LMICs limit scale-up of tobacco control evidence-based interventions (EBIs). The Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program was previously shown to help teachers quit tobacco and schools adopt tobacco control policies. We are comparing smartphone-based training to in-person training to scale up the TFT-TFS program.

Methods: Hybrid III cluster-randomized comparative effectiveness trial, involving 200 high schools and high secondary schools in Madhya Pradesh, India. To implement the TFT-TFS program, researchers randomly assigned schools to either smartphone-based (n=110 schools) or in-person (n=90 schools) training arms. Trained teachers from both arms implement the program in their respective schools. We will examine differences in program implementation, reach, and effectiveness between schools from the two arms. Post-implementation mixed-methods will employ the consolidated framework for implementation research (CFIR) to identify contextual factors influencing implementation.

Conclusions: This study will scientifically and economically evaluate smartphone-based training to expand the use of EBIs for tobacco control in LMICs. Analyzing the contextual influences on TFT-TFS use in each training program will allow this work to create actionable guidance for education departments and groups involved in implementing smartphone-based training. These findings will help the CFIR strengthen its evidence on how to implement tobacco control EBIs successfully in low-resource environments.

Trial Registration: This study is registered at ClinicalTrials.gov ID: NCT05500235.

Author Biographies

Mangesh S. Pednekar, Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Priyanka Ghosh, Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Research Scientist, Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Smita Warke, Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA

Occupational Health Services, Dana-Farber Cancer Institute. Boston, MA, USA

Leah C. Jones, Public Health Editor, Boston, MA, USA

Public Health Editor, Boston, MA, USA

Sameer Narake, Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Senior Statistician, Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Glorian Sorensen, Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA

Center for Community-Based Research, Dana-Farber Cancer Institute, Boston, MA, USA, 

Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA

Prakash C. Gupta, Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Research Department, Healis Sekhsaria Institute for Public Health, Navi Mumbai, Maharashtra, India

Eve M. Nagler, Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA

Department of Social and Behavioral Sciences, Harvard TH Chan School of Public Health

References

World Health Organization. Tobacco. 2023. Available at: https://www.who.int/news-room/fact-sheets/detail/tobacco. Accessed on 01 June 2025.

Gupta PC, Ray CS, Murti PR, Sinha DN. Rising incidence of oral cancer in Ahmedabad city. Indian J Cancer. 2014;1:S67-72. DOI: https://doi.org/10.4103/0019-509X.147476

Sinha DN, Palipudi KM, Gupta PC, Singhal S, Ramasundarahettige C, Jha P, et al. Smokeless tobacco use: a meta-analysis of risk and attributable mortality estimates for India. Indian J Cancer. 2014;51:S73-7. DOI: https://doi.org/10.4103/0019-509X.147477

Sorensen G, Pednekar MS, Sinha DN, Stoddard AM, Nagler E, Aghi MB, et al. Effects of a tobacco control intervention for teachers in India: results of the Bihar school teachers study. Am J Public Health. 2013;103:2035-40. DOI: https://doi.org/10.2105/AJPH.2013.301303

Mathur N, Pednekar M, Sorensen G, Nagler E, Stoddard A, Lando H, et al. Adoption and Implementation of Tobacco Control Policies in Schools in India: Results of the Bihar School Teachers Study. Asian Pac J Cancer Prev. 2016;17:2821-6.

Government of India. DIKSHA National Digital Infrastructure for Our Teachers. 2020. Available at: https://www.india.gov.in/spotlight/diksha-national-digital-infrastructure-teachers. Accessed on 24 March 2024.

Mormina M, Pinder S. A conceptual framework for training of trainers (ToT) interventions in global health. Glob Health. 2018;14:100. DOI: https://doi.org/10.1186/s12992-018-0420-3

Angela B, Chris D, Julie E. The 8 Essentials for Mobie Learning Success in Education. San Diego, CA: Qualcomm Wireless Reach. 2018.

Curran V, Matthews L, Fleet L, Simmons K, Gustafson DL, Wetsch L. A Review of Digital, Social, and Mobile Technologies in Health Professional Education. J Contin Educ Health Prof. 2017;37:195-206. DOI: https://doi.org/10.1097/CEH.0000000000000168

Lall P, Rees R, Law GCY, Dunleavy G, Cotic Z, Car J. Influences on the Implementation of Mobile Learning for Medical and Nursing Education: Qualitative Systematic Review by the Digital Health Education Collaboration. J Med Internet Res. 2019;21:e12895. DOI: https://doi.org/10.2196/12895

Telecom Regulatory Authority of India. Highlights of Telecom Subscription Data. 2024. Available at: www.trai.gov.in. Accessed on 27 February 2022.

Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019;280:112513. DOI: https://doi.org/10.1016/j.psychres.2019.112513

Curry L, Nunez-Smith M. Mixed Methods in Health Sciences Research: A Practical Primer. Thousand Oaks, CA: Sage. 2015. DOI: https://doi.org/10.4135/9781483390659

Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89:1322-7. DOI: https://doi.org/10.2105/AJPH.89.9.1322

Damschroder LJ, Reardon CM, Widerquist MA, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022;17:75. DOI: https://doi.org/10.1186/s13012-022-01245-0

Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. DOI: https://doi.org/10.1136/bmj.c332

Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017;356:i6795. DOI: https://doi.org/10.1136/bmj.i6795

Government of India. Census India - 2011. 2011. Available at: https://www.censusindia.co.in. Accessed on 27 February 2024.

Tata Institute of Social Sciences (TISS), Ministry of Health and Family Welfare G of India. Global Adult Tobacco Survey GATS 2 India 2016-17. New Delhi, India: Ministry of Health and Family Welfare, Government of India. 2018.

Sinha DN, Gupta PC. Tobacco use among students and school personnel in India. Asian Pac J Cancer Prev. 2007;8:417-21.

Tata Memorial Centre. GATS2: Global Adult Tobacco Survey Fact Sheet - Madhya Pradesh 2016-2017. 2018. Available at: https://tmc.gov.in/ images/act/Madhya%20Pradesh%20GATS-2%20Factsheet.pdf. Accessed on 25 May 2019.

Karuppusamy B, Paulson W, Chellappan S, Behera SK, Balabaskaran Nina P. District-level epidemiology, hot spots and sociodemographic determinants of tobacco use in Indian men and women: analysis of national family health survey-4 (2015-16). Public Health. 2021;194:127-34. DOI: https://doi.org/10.1016/j.puhe.2021.03.001

Aghi M, Nagler E, Lando H, Pednekar M, Gupta P, Sorensen G. Training Lay Interventionists to Support Tobacco Cessation among Teachers in India. Int J Health Promot Educ. 2016;54:304-17. DOI: https://doi.org/10.1080/14635240.2016.1193761

Nagler EM, Pednekar M, Sinha DN, Stoddard AM, Narake S, Adhikari K, et al. 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;4:26334895231159428. DOI: https://doi.org/10.1177/26334895231159428

Saigal A. Demonstrating a situated learning approach for in-service teacher education in rural India: The Quality Education Programme in Rajasthan. Teach Teach Educ. 2012;28:1009-17. DOI: https://doi.org/10.1016/j.tate.2012.05.007

Bryan RL, Kreuter MW, Brownson RC. Integrating adult learning principles into training for public health practice. Health Promot Pr. 2009;10:557-63. DOI: https://doi.org/10.1177/1524839907308117

Ballew P, Castro S, Claus J, Kittur N, Brennan L, Brownson RC. Developing web-based training for public health practitioners: what can we learn from a review of five disciplines? Health Educ Res. 2013;28:276-87. DOI: https://doi.org/10.1093/her/cys098

Pawar PS, Nagler EM, Gupta PC, Stoddard AM, Lando HA, Shulman L, et al. Tracking intervention delivery in the “Tobacco-Free Teachers/Tobacco-Free Society” program, Bihar, India. Health Educ Res. 2015;30:731-41. DOI: https://doi.org/10.1093/her/cyv039

Bates D, Mächler M, Bolker B, Walker S. Fitting Linear Mixed-Effects Models Using lme4. J Stat Softw. 2015;67:1-48. DOI: https://doi.org/10.18637/jss.v067.i01

IBM Corp. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. 2017.

Nagler EM, Sinha DN, Pednekar MS, Stoddard AM, Gupta PC, Mathur N, et al. Social contextual factors and tobacco use among Indian teachers: insights from the Bihar School Teachers’ Study. Prev Med. 2015;74:24-30. DOI: https://doi.org/10.1016/j.ypmed.2015.01.021

Pednekar MS, Nagler EM, Gupta PC, Pawar PS, Mathur N, Adhikari K, et al. Scaling up a tobacco control intervention in low resource settings: a case example for school teachers in India. Health Educ Res. 2018;33:218-31. DOI: https://doi.org/10.1093/her/cyy011

Kegler MC, Liang S, Weiner BJ, Tu SP, Friedman DB, Glenn BA, et al. Measuring Constructs of the Consolidated Framework for Implementation Research in the Context of Increasing Colorectal Cancer Screening in Federally Qualified Health Center. Health Serv Res. 2018;53:4178-203. DOI: https://doi.org/10.1111/1475-6773.13035

Damschroder LJ, Lowery JC. Evaluation of a large-scale weight management program using the consolidated framework for implementation research (CFIR). Implement Sci. 2013;8:51. DOI: https://doi.org/10.1186/1748-5908-8-51

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38:65-76. DOI: https://doi.org/10.1007/s10488-010-0319-7

QSR International Pty Ltd. NVivo qualitative data analysis program. Melbourne, Australia: QSR International Pty Ltd. 2019. Available at: www.qsrinternational.com/nvivo/. Accessed on 25 May 2019.

Schutt R. Investigating the Social World: The Process and Practice of Research. 5th ed. Thousand Oaks, CA: Sage. 2006

Smith J, Firth J. Qualitative data analysis: the framework approach. Nurse Res. 2011;18. DOI: https://doi.org/10.7748/nr2011.01.18.2.52.c8284

O’Donovan J, Bersin A, O’Donovan C. The effectiveness of mobile health (mHealth) technologies to train healthcare professionals in developing countries: a review of the literature. BMJ Innov. 2015;1:33. DOI: https://doi.org/10.1136/bmjinnov-2014-000013

Downloads

Published

2026-04-29

How to Cite

Pednekar, M. S., Ghosh, P., Warke, S., Jones, L. C., Narake, S., Sorensen, G., Gupta, P. C., & Nagler, E. M. (2026). Scaling up tobacco control in India: a protocol for a hybrid III cluster randomized trial comparing smartphone to in-person training to implement a tobacco control program for school teachers. International Journal of Clinical Trials, 13(2), 222–231. https://doi.org/10.18203/2349-3259.ijct20261388