| CTRI Number |
CTRI/2025/02/081457 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the knowledge level and ready to stop smoking and / or alcoholism among tribal adolescent before and after health teaching and collect the factors of smoking and alcoholism from public |
|
Scientific Title of Study
|
A Mixed study to explore Stakeholder’s perspective and evaluate the Effectiveness of Community- based health literacy intervention on knowledge and readiness to quit Smoking and/or Alcoholism among tribal adolescents at Kuttichal Panchayat,Thiruvananthapuram, Kerala. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LIZAL |
| Designation |
PhD Scholar |
| Affiliation |
SIMET College of Nursing Neyyatinkara |
| Address |
PULARI CHEMBOOR
OTTASEKHARAMANGALAM
TRIVANDRUM
KERALA
Assistant Professor
Room No 2
Community Health Nursing
Perumpazhuthoor
Perumpazhuthoor PO
Thiruvananthapuram District
Thiruvananthapuram
KERALA
695125
India |
| Phone |
9400725530 |
| Fax |
|
| Email |
lizadivakaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lilly Christopher |
| Designation |
Professor |
| Affiliation |
Meenakshi Academy Of Higher Education And Research |
| Address |
Faculty Of Nursing
Dean Students Affairs
Medical Surgical Nursing
Meenakshi Academy Of Higher Education And Research
Chennai
Faculty Of Nursing
Dean Students Affairs
Medical Surgical Nursing
Meenakshi Academy Of Higher Education And Research
Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9981307063 |
| Fax |
|
| Email |
lillyc64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lilly Christopher |
| Designation |
Professor |
| Affiliation |
Meenakshi Academy Of Higher Education And Research |
| Address |
Faculty Of Nursing
Dean Students Affairs
Medical Surgical Nursing
Meenakshi Academy Of Higher Education And Research
Chennai
Faculty Of Nursing
Dean Students Affairs
Medical Surgical Nursing
Meenakshi Academy Of Higher Education And Research
Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
9981307063 |
| Fax |
|
| Email |
lillyc64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Academy Of Higher Education
Deemed to be University U/S 3 of UGC Act, 1956
No 12 Vembuliamman Koil Street
West K K Nagar
Chennai - 600078
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Liza L |
| Address |
PhD Scholar
Meenakshi Academy Of Higher Education
Deemed to be University U/S 3 of UGC Act, 1956
No 12 Vembuliamman Koil Street
West K K Nagar
Chennai - 600078
Tamil Nadu
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Manikandan |
Elimala Chonampara Uttaramcode |
Panchayat President
Room No 1
Kuttichal Panchayat
Kuttichal PO
Thiruvananthapuram
KERALA |
9446904530
shenin.jmo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHER IEC, Vembuliamman Koil Street, West KK Nagar, Chennai, Tamil Nadu, India – 600 078 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescents who are using tobacco and / or alcohol |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community Based Health Literacy Intervention |
Health teaching regarding the ill-effects of smoking and alcoholism and a video show - 1 day |
| Comparator Agent |
NOT APPLICABLE |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Tribal adolescents between 10 to 19 years.
Who can read, talk and understand Malayalam.
Tribal adolescents who are willing to participate in this study.
Tribal adolescents who are smokers and alcoholic.
Tribal adolescents 10 to 18 years who are having consent and assent forms.
Tribal adolescents 19 year who are having consent form.
|
|
| ExclusionCriteria |
| Details |
Tribal adolescents who were medically diagnosed with psychiatric illness.
Tribal adolescents who are severely sick.
Non tribal adolescents.
Tribal adolescents who participate in qualitative studies.
Tribal adolescents who had or under de-addiction treatment, medication and counseling.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the perspective of Stakeholders on smoking and/ or alcoholism
|
To assess the knowledge level and readiness to quit smoking and / or alcoholism at 4th week, 12th week and 24th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the relationship between knowledge & readiness to quit Smoking and/ or alcoholism |
To find the association between pre-test level of knowledge & readiness to quit smoking and/or alcoholism at 1st day of data collection |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="89"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
PHASE I (QUALITATIVE PHASE): In this phase the primary investigator will gather information regarding the contributing factors of smoking and alcoholism among stakeholders.
PHASE II (QUANTITATIVE PHASE): In this phase the primary investigator will screen the adolescent and find the alcohol tobacco dependence level. In the next stage, knowledge level on ill-effects of smoking and alcoholism will be assessed by using a knowledge questionnaire and readiness to quit smoking and alcoholism will be assessed by using contemplation ladder. After that, a community health teaching will be given and a video will be shown. After the intervention post test will be done at first month, third month and sixth month with the same knowledge questionnaire and contemplation ladder. |