| CTRI Number |
CTRI/2024/04/065616 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study on Non-Communicable Diseases among youth of urban slums of Pune city. |
|
Scientific Title of Study
|
A study on Non-Communicable Diseases among youth and young adults from urban slums in Pune City. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuradha V Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
HIRABAI COWASJI JEHANGIR MEDICAL RESEARCH INSTITUTE |
| Address |
HIRABAI COWASJI JEHANGIR MEDICAL RESEARCH INSTITUTE
Block 5, Lower Ground Floor
Jehangir Hospital,
32,Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha V Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
HIRABAI COWASJI JEHANGIR MEDICAL RESEARCH INSTITUTE |
| Address |
HIRABAI COWASJI JEHANGIR MEDICAL RESEARCH INSTITUTE
Block 5, Lower Ground Floor
Jehangir Hospital,
32,Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha V Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
HIRABAI COWASJI JEHANGIR MEDICAL RESEARCH INSTITUTE |
| Address |
HIRABAI COWASJI JEHANGIR MEDICAL RESEARCH INSTITUTE
Block 5, Lower Ground Floor
Jehangir Hospital,
32,Sassoon Road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hirabai Cowasji Jehangir Medical Research Institute, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Anuradha V Khadilkar |
| Address |
Block 5, Lower Ground floor, Jehangir Hospital
32, Sassoon Road,
Pune 411001 |
| 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 |
| Dr Anuradha V Khadilkar |
Pune Urban slums |
Barmashel, Tadiwala Road, Bhawani Peth.
Pune
MAHARASHTRA |
9850244305
anuradhavkhadilkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jehangir Clinical Development Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
15-30 Years old healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
In-person Intervention |
6 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Virtual and In-person Intervention |
6 months |
| Intervention |
Virtual Intervention |
6 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Non-migrant families, living in the selected slum for atleast 1 year and one smartphone in the family. |
|
| ExclusionCriteria |
| Details |
Migrant families, living in the selected slums for less than one year, participants not
having a smartphone, with known serious chronic illness (as determined by physician) and not agreeing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the prevalence and risk factors of non communicable diseases in youths of urban slums |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine change in behaviour post intervention & to identify which mode of intervention is most suited in bringing about the behavioural change among youths & young adults for controllling risk factors of NCDs. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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 1 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| 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 aim of the study is to assess prevalence and develop and implement a community based and culturally appropriate hybrid (virtual + in person) intervention to prevent NCDs among youth and young adults (15-30 years). For this, 480 healthy individuals will be randomly identified in 3 urban slums of Pune city (160 in each group). Prevalence of non-communicable diseases and risk factor will be studied. A 6 month behavioural intervention program (using youth as changemakers) will be given in the 3 groups, where group 1 will receive only virtual intervention, group 2 will receive only in-person intervention and group-3 will receive both virtual and in-person intervention. The effect of intervention will be studied in the 3 groups. |