| CTRI Number |
CTRI/2025/08/093793 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A 2-Year Prospective Non-Interventional Study Evaluating the Effectiveness of Counselling in Participants of the BPOD (Blood Pressure, Obesity, Diabetes) Awareness Study at 6-Month Intervals.
BPOD Awareness Study : Follow Up. |
|
Scientific Title of Study
|
A 2-Year Prospective Clinical Study Evaluating the Effectiveness of Counseling in Participants of the BPOD (Blood Pressure, Obesity, Diabetes) Awareness Study at 6-Month Intervals.
BPOD AWARENESS STUDY : FOLLOW UP
|
| Trial Acronym |
BPOD 2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bharat Bhushan Kukreja |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Bharats Clinic |
| Address |
Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001(Assam)
Kamrup
ASSAM
781001
India
Kamrup
ASSAM
781001
India |
| Phone |
9864093048 |
| Fax |
|
| Email |
bharatkukeja@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Bhushan Kukreja |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Bharats Clinic |
| Address |
Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001(Assam)
Kamrup
ASSAM
781001
India
Kamrup
ASSAM
781001
India |
| Phone |
9864093048 |
| Fax |
|
| Email |
bharatkukeja@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Bhushan Kukreja |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Bharats Clinic |
| Address |
Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001(Assam)
Kamrup
ASSAM
781001
India
Kamrup
ASSAM
781001
India |
| Phone |
9864093048 |
| Fax |
|
| Email |
bharatkukeja@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Bharat Bhushan Kukreja
Dr. Bharats Clinic
Room no.1, Ground Floor, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam)
Kamrup
Assam
781001
India |
|
|
Primary Sponsor
|
| Name |
Dr Bharat Bhushan Kukreja |
| Address |
Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001(Assam)
Kamrup
ASSAM
781001
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 |
| Dr Bharat Bhushan Kukreja |
Dr Bharats Clinic |
Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001(Assam)
Kamrup
ASSAM
781001
India
Room no.1, Ground Floor, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam)
Kamrup
Assam
781001
India
Kamrup
ASSAM |
09864093048
bharatkukeja@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECRC-HEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
-General population
-At risk population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All participants who have consented to participate in the BPOD study and received counseling.
2. Suffering from either Hypertension, T2DM and Obesity or all of them.
i. Person with BMI values above 25.
ii. Person with systolic BP value, greater than 120 and diastolic value less than 80
iii. Person with HbA1c values from 5.6 to 6.4 i.e., pre-diabetic
iv. Skin tags, Acanthosis Nigricans and other skin markers of insulin resistance
-Any other co-morbidity
|
|
| ExclusionCriteria |
| Details |
1. Participants who have not received counseling. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•This study will enable public to be aware of primary prevention of NCDs.
•This study will help in establishing the effectiveness after counseling on lifestyle diseases leading to
-improved blood pressure control
-weight loss or maintenance
-improved blood sugar control
|
36 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•This study will help in establishing the effectiveness after counseling on lifestyle diseases leading to
-improved blood pressure control
-weight loss or maintenance
-improved blood sugar control |
36 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
15/09/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bharatkukeja@hotmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The recent findings from ICMR study Indiab on NCDs (Anjana 2011et al.) showing diabetes
11.4%, prediabetes 15.3%, hypertension 35.5%, generalized obesity 28.6% in urban India,
prompted us to design a questionnaire based study amongst the attendants of the patients who
comes for treatment of these clinical conditions. NCDs being asymptomatic in more than 50% of
the population, it is pertinent that awareness and preventive measures be taken early to
highlight the factors which would help health care providers in defining preventive strategies for
primary prevention |