Comparing Smartphone to In-person Training to Scale up a Tobacco Control Program for Teachers in India

Sponsor
Harvard School of Public Health (HSPH) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05500235
Collaborator
Healis-Sekhsaria Institute for Public Health (Other)
1,800
2
2
24
900
37.5

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smart phone based training
  • Behavioral: In person training
N/A

Detailed Description

Tobacco-related deaths are rising rapidly in low and middle-income countries (LMICs). India's population 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 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, school teachers are respected community leaders, 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, and we saw significant improvements in the adoption and implementation of tobacco control policies. As a critical next step in scaling up our TFT-TFS tobacco control EBI, investigators have turned their focus to expanding the training of those implementing the program in schools, i.e., school headmasters. The investigators will compare two models of TFT-TFS training of headmasters-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 on 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 headmasters 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, headmasters in both groups will implement the TFT-TFS program within their schools. Investigators will compare the training arms regarding program effectiveness (tobacco use cessation), implementation, cost, and reach.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Comparative effectiveness trialComparative effectiveness trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Scaling up Tobacco Control in Lndia: Comparing Smartphone to In-person Training for Implementing an Evidence-based Intervention to Reduce Tobacco Use Among Schoolteachers
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Smart phone based training

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

Behavioral: Smart phone based training
The study team will acquaint headmasters with the Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program and the smartphone training app. Headmasters will receive six monthly trainings on their phones, including brief videos followed by quizzes with feedback, discussion forums to promote peer learning, demonstration of techniques, and the ability to review the content as needed. Headmasters will implement TFT-TFS at monthly school meetings with teachers and parents. 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.

Experimental: In person training

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

Behavioral: In person training
Headmasters will receive three face-to-face trainings, each 60-75 minutes long and held at convenient locations. The study team will introduce headmasters to the TFT-TFS program and teach them how to use paper-based materials. The trainings will encourage participants to discuss successes and come up with solutions to overcome challenges. Headmasters will implement TFT-TFS at monthly school meetings with teachers and parents. 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.

Outcome Measures

Primary Outcome Measures

  1. Tobacco use cessation among teachers [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

All teachers and principals employed in schools in both study arms

Exclusion Criteria:

• None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
2 Healis Sekhsaria Institute for Public Health Mumbai India

Sponsors and Collaborators

  • Harvard School of Public Health (HSPH)
  • Healis-Sekhsaria Institute for Public Health

Investigators

  • Principal Investigator: Eve Nagler, ScD, MPH, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eve Nagler, Principal Investigator, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier:
NCT05500235
Other Study ID Numbers:
  • IRB20-2157
First Posted:
Aug 15, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 16, 2022