| CTRI Number |
CTRI/2024/05/066834 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
"Effectiveness of Tobacco Cessation Intervention among Reproductive Age Females in Akole Tribal Block of Ahmednagar |
|
Scientific Title of Study
|
A Quasi Experimental Study to assess effectiveness of
tobacco cessation intervention among reproductive age
females in Akole Tribal block of Ahmednagar
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pandit Atul Suresh |
| Designation |
PG Student |
| Affiliation |
School Of Public Health And Social Medicine PIMS Dist Ahmednagar Loni Maharashtra 413736 |
| Address |
Department of School Of Public Health And Social Medicine
Class room No 1 PIMS Dist Ahmednagar Loni Maharashtra 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7219627875 |
| Fax |
|
| Email |
atulpandit990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swanand D Tilekar |
| Designation |
Assistnt Professor and Research Officer |
| Affiliation |
School Of Public Health And Social Medicine PIMS Dist Ahmednagar Loni Maharashtra 413736 |
| Address |
Department of School Of Public Health And Social Medicine
Faculty Room No 2 PIMS Dist Ahmednagar Loni Maharashtra 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8275201223 |
| Fax |
|
| Email |
swanandtilekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swanand D Tilekar |
| Designation |
Assistnt Professor and Research Officer |
| Affiliation |
School Of Public Health And Social Medicine PIMS Dist Ahmednagar Loni Maharashtra 413736 |
| Address |
Department of School Of Public Health And Social Medicine
Faculty Room No 2 PIMS Dist Ahmednagar Loni Maharashtra 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
8275201223 |
| Fax |
|
| Email |
swanandtilekar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prvara institute of medical science |
| Address |
School of Public
Health and Social Medicine PIMS Dist Ahmednagar Loni Maharashtra 413736 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swanand D Tilekar |
SPHSM PIMS DU |
Department of School of Public Health and Social Medicine Faculty Room No 2 Pravara Institute Of Medical Sciences Deemed to be University
Loni Bk 413736
Ahmadnagar
MAHARASHTRA |
8275201223
swanandtilekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SPHSM PIMS DU INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tobacco Consumers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Single arm pretest and post test design |
“5A Model “ ask, advise, assess, assist, arrange .
The tobacco cessation intervention utilizes a cluster sampling method to select 15 villages within the Akole tribal block, ensuring comprehensive coverage of reproductive women of target population. The calculated sample size of 216 participants is distributed across these villages.A door-to-door approach will be employed to deliver the intervention, pattern of tobacco use . The demographic details and information regarding tobacco harmful impact and accommodating the lifestyle and work patterns of tribal women. Intervention sessions will be scheduled in both morning and evening time slots to optimize accessibility. Additionally, select sessions are conducted in pairs to enhance social support and motivation among participants.The intervention adopts a brief intervention model, incorporating the "ask, advise, assess, assist, arrange" framework. This approach involves systematically inquiring about tobacco use, providing personalized advice on cessation, assessing readiness to quit, offering practical assistance in developing cessation plans, and arranging follow-up support. Frgerstrom Nicotine Dependence scale along with Global Adult Tobacco Survey [GATS] Questionnaire used . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
women o reproductive age
Speak English Hindi or Marathi
women ready to come for the follow up visit
|
|
| ExclusionCriteria |
| Details |
Speak other than English, Hindi, or Marathi
women with psychiatric disorders and learning disability
women with major systematic problem /syndrome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know pattern of consumption, factor influencing usage and potential health implication of tobacco
To know reduction in tobacco use, quit rates, health improvements, intervention effectiveness and long term success.
Find association between demographic variables and tobacco cessation intervention.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
association between demographic variables and tobacco cessation intervention.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The research is a quasi-experimental study targeting tribal women of reproductive age, with a sample size of 216 participants selected using cluster sampling ,,15 villages are selected to fulfill all tribal block of Ahmednagar district .The intervention involves administering a 5A model tobacco cessation intervention after a 30-day period post-baseline assessment. Primary outcomes are evaluated after post-test . The study aims to assess the impact of the intervention on tobacco cessation among tribal women. |