NCT05500235

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,040

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

June 27, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

August 11, 2022

Last Update Submit

November 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tobacco use cessation among teachers

    Self-administered school personnel survey completed by teachers and principals. Based on the school personnel surveys, the investigators will assess self-report tobacco use at baseline and immediate post intervention and compare measures between the two arms to assess the effectiveness of the intervention.

    Baseline and Immediate post intervention

Study Arms (2)

Smart phone based training

EXPERIMENTAL

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

In person training

EXPERIMENTAL

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

Interventions

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 smartphones, 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.

Smart phone based 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 participants 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.

In person training

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All teachers and principals employed in schools in both study arms

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healis Sekhsaria Institute for Public Health

Indore, Madhya Pradesh, India

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Eve Nagler, ScD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Comparative effectiveness trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

June 27, 2023

Primary Completion

August 21, 2024

Study Completion

July 31, 2025

Last Updated

November 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations