| CTRI Number |
CTRI/2025/01/079777 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the Diabetes knowledge, self care practices and lifestyle parameters among type 2 diabetic population in Mumbai. (40-55 years) |
|
Scientific Title of Study
|
Diabetes knowledge, self care practices and lifestyle parameters among type 2 diabetic population. (40-55 years) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Girish Malkapurkar |
| Designation |
Student |
| Affiliation |
Dr BMN College Of Home Science |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9167824258 |
| Fax |
|
| Email |
nisha.malkapurkar2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Shekar |
| Designation |
Associate Professor |
| Affiliation |
Dr BMN College Of Home Science |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha Shekar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr BMN College Of Home Science |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College Of Home Science Matunga, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Nisha Malkapurkar |
| Address |
Dr BMN College Of Home Science Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 |
| 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 Anjali Mulke |
Anjangiri Clinic |
Building No.8, Flat no. 22, MMRDA society, Kanjurmarg West, Mumbai
Mumbai
MAHARASHTRA |
9730476780
anjalimulke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NA |
Approved |
| Seva Mandal Educational Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
N/A |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Both genders above age 40 years and upto 55 years
Participants diagnosed with diabetes type 2
Participants willing to be a part of the study
|
|
| ExclusionCriteria |
| Details |
Population with type 1 diabetes mellitus and gestational diabetes mellitus
Population with serious illness |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the diabetes knowledge, selfcare practices and lifestyle parameters followed by the diabetic population. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will help to assess & understand the knowledge, self care behaviors & dietary
patterns that can negatively or positively affect the diabetic population |
4 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/02/2025 |
| 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="10"
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 study aims to assess and understand the knowledge about diabetes, self care practices followed and other lifestyle parameters in diabetic type 2 population in India. The objectives of the study are To assess the knowledge regarding diabetes using a questionnaire. To evaluate their self-care practice using a validated questionnaire . To assess the dietary pattern using a food frequency questionnaire. |