NCT05346991

Brief Summary

Disseminating an evidence-based tobacco control intervention for School Teachers

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,102

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

April 15, 2022

Last Update Submit

April 23, 2022

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately post-intervention

Secondary Outcomes (2)

  • School tobacco control policy implementation - School Observation

    Immediately post-intervention

  • School tobacco control policy implementation - Teachers' Report

    Immediately post-intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

Implementation of the Tobacco-Free Teachers, Tobacco Free Society program in government schools in Bihar, India

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

Interventions

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.

Intervention arm

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All teachers and principals employed in intervention and control schools

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Healis Sekhsaria Institute for Public Health

Mumbai, India

Location

Related Publications (1)

  • 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.

    PMID: 37091538DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Glorian Sorensen, PhD, MPH

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Social and Behavioral Sciences

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 26, 2022

Study Start

June 1, 2018

Primary Completion

June 30, 2019

Study Completion

July 31, 2020

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)IN(1)