NCT02103868

Brief Summary

Zari workers in Mumbai city will be assessed for tobacco consumption habit. They will be divided into 3 arms as - 1) First arm will get Medium intensity tobacco cessation intervention 2) Second arm will get low intensity tobacco cessation intervention 3) Control arm. At the end of 12 months of intervention quit rates will be compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

April 1, 2014

Last Update Submit

February 4, 2015

Conditions

Keywords

Tobacco cessationZari workerBehavior therapyQualitative ResearchMumbai

Outcome Measures

Primary Outcomes (1)

  • Tobacco Quit Rate

    Tobacco quit rates in moderate intensity behavioural intervention, low intensity behavioral intervention and control group will be compared at the end of 12 months

    12 Months

Study Arms (3)

Control

NO INTERVENTION

No active intervention will be given for tobacco cessation.

Medium Intervention

EXPERIMENTAL

Tobacco Cessation Counseling : Medium intervention in the form of 3 contact sessions will be given for tobacco cessation.

Behavioral: Tobacco Cessation Counseling

Low intensity intervention

EXPERIMENTAL

Tobacco Cessation Counseling: Only a single contact session will be done for tobacco cessation.

Behavioral: Tobacco Cessation Counseling

Interventions

Doing group and personal counseling for tobacco cessation

Also known as: TCC
Low intensity interventionMedium Intervention

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are willing to participate
  • All workers employed in each of the listed zari units.
  • Who are willing to give informed consent.

You may not qualify if:

  • \. Who are NOT willing to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Links

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Sharmila A Pimple, Professor

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR
  • Gauravi A Mishra, Assoc Prof

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR
  • Parishi Majmudar, MSW

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmila A Pimple, Professor

CONTACT

Gauravi A Mishra, Assoc Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Preventive Oncology

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 4, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations