NCT01722747

Brief Summary

BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a tobacco-control intervention geared towards school teachers in Bihar, India. This cluster randomized trial aims to promote tobacco use cessation among teachers and increase tobacco policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role models for youth and key opinion leaders related to community norms, they represent an important group for tobacco control. Teachers in Bihar also have reported high rates of tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of teachers in the eastern region of India (which includes Bihar) use some form of tobacco, compared to the national average of 29%. This study aims to reduce these numbers through discussion groups with teachers, individual cessation counseling, educational materials, and a tobacco policy workgroup in each intervention school. This study is a collaboration between US researchers and researchers at the Healis-Sekhsaria Institute for Public Health, Mumbai India.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
945

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

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, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

3.1 years

First QC Date

November 1, 2012

Last Update Submit

March 19, 2013

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

  • 6-month abstinence from tobacco

    assessed 9-months post-intervention

Secondary Outcomes (2)

  • Adoption of a school tobacco policy

    9-month post-intervention

  • short-term tobacco use cessation

    Average of 3 weeks post-intervention

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)

Behavioral: Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)

Delayed Intervention Control condition

NO INTERVENTION

Receives abbreviated 3-month delayed intervention after final data collection time point

Interventions

Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)BEHAVIORAL

A 7-month intervention was conducted over one academic year \& included the following core components: 1. A Lead Teacher (LT) in each school was appointed and trained to facilitate the program on-site; 2. A tobacco policy was implemented; 3. Study health educators and LTs conducted group discussions with teachers addressing 6 intervention themes; 4. Materials; 5. Support for tobacco use cessation. Schools randomized to delayed intervention control condition did not receive any intervention until after final data collection, when they were given a 3-month shortened intervention.

Intervention Condition

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Government schools including grades 8-10 from within 10 school districts

You may not qualify if:

  • Schools with fewer than 8 teachers
  • Schools located in flood zones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Preventive Oncology

Patna, Bihar, India

Location

Related Publications (2)

  • Nagler EM, Pednekar MS, Viswanath K, Sinha DN, Aghi MB, Pischke CR, Ebbeling CB, Lando HA, Gupta PC, Sorensen GC. Designing in the social context: using the social contextual model of health behavior change to develop a tobacco control intervention for teachers in India. Health Educ Res. 2013 Feb;28(1):113-29. doi: 10.1093/her/cys060. Epub 2012 Jun 4.

    PMID: 22669010BACKGROUND

  • Pischke CR, Galarce EM, Nagler E, Aghi M, Sorensen G, Gupta PC, Pednekar MS, Sinha DN, Viswanath K. Message formats and their influence on perceived risks of tobacco use: a pilot formative research project in India. Health Educ Res. 2013 Apr;28(2):326-38. doi: 10.1093/her/cys112. Epub 2012 Dec 6.

    PMID: 23221589BACKGROUND

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Glorian C. Sorensen, PhD, MPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Society, Human Development and Health

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 7, 2012

Study Start

June 1, 2009

Primary Completion

July 1, 2012

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

IN(1)