NCT01958255

Brief Summary

The aim of this project was to provide tobacco cessation services to the women at the community level at their door steps and thus establish a model community based tobacco cessation programme which could be replicated in other communities and could be taken up by National Tobacco Control Programme (NTCP), in future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

September 27, 2013

Last Update Submit

April 27, 2018

Conditions

Tobacco Smoking Behavior

Keywords

tobacco quit rates

Outcome Measures

Primary Outcomes (1)

  • To assess tobacco quit rates

    The participant women were intervened thrice for counseling about quitting tobacco and quit rates were assessed at the end of one year

    Baseline and 12 months

Secondary Outcomes (2)

  • To assess pre-intervention knowledge, attitude and practices about tobacco use.

    baseline

  • To assess post-intervention knowledge, attitude and practices of tobacco use by participant women.

    9 month and 12 month

Study Arms (1)

Tobacco cessation counseling

OTHER

planned intervention for tobacco cessation counseling

Behavioral: planned intervention for tobacco cessation counseling

Interventions

planned intervention for tobacco cessation counselingBEHAVIORAL

game session for rapport building followed by group discussion and tobacco cessation counseling

Tobacco cessation counseling

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all current tobacco users at the time of screening under TMH-MOP project

You may not qualify if:

  • All those who refused to participate and those who could not be contacted during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital, Parel

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gauravi A Mishra, M.D.PSM

    Tata Memorial Hospital, Parel, Mumbai,India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Physician

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 9, 2013

Study Start

May 1, 2012

Primary Completion

June 1, 2013

Study Completion

April 1, 2014

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

IN(1)