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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01958255
Other study ID # TMHPO912
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date April 2014

Study information

Verified date April 2018
Source Tata Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study was extended over a period of one year. There were 3 interventions given at the interval of 3 months each. The post intervention questionnaire regarding knowledge, attitude and practices was planned filled at the end of the programme i.e. 9th to 12th month from start of the programme. A community based tobacco cessation programme, which has the potential of being first of its kind, for women, was planned by the department of Preventive Oncology for the women in a geographical community in and around Mankhurd in Mumbai,for providing tobacco cessation counseling services. Doorstep services were provided to these women as they were unlikely to avail the tobacco cessation services at the clinic in TMH since their priority is managing household chores and caretaking of their family. The selected community was a part of women cancer screening programme namely; Tata Memorial Hospital Mobile Outreach Programme (TMH-MOP). The women who were current tobacco users at the time of screening under TMH-MOP were enrolled for this study.The women were intervened thrice at an interval of 3 months each and tobacco cessation counseling was provided at each intervention. The post intervention data was collected at the end of all the 3 counseling sessions. Sessions were held for rapport building with the participant women. Questionnaire were filled to record the information on the details of different forms of tobacco usage, factors responsible for initiation and continuation of tobacco use, pre-intervention and post-intervention knowledge, attitudes and practices regarding tobacco habits and severity of tobacco use (Fagerstroms scale). This programme was aimed at creating awareness and educating women regarding the health hazards of tobacco use, at the community level, at their door step.


Recruitment information / eligibility

Status Completed
Enrollment 279
Est. completion date April 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
planned intervention for tobacco cessation counseling
game session for rapport building followed by group discussion and tobacco cessation counseling

Locations

Country Name City State
India Tata Memorial Hospital, Parel Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To assess pre-intervention knowledge, attitude and practices about tobacco use. A questionnaire to assess the baseline knowledge, attitude and practices about tobacco use by participant women was filled during first intervention baseline
Secondary To assess post-intervention knowledge, attitude and practices of tobacco use by participant women. A questionnaire to assess the baseline knowledge, attitude and practices about tobacco use by participant women was filled during post intervention 9 month and 12 month
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