| CTRI Number |
CTRI/2025/08/093369 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Study to see if eating less salt helps lower blood pressure in adults with high BP in rural India |
|
Scientific Title of Study
|
Effect of a structured behavioural intervention targeting dietary salt intake modification among individuals with hypertension, in primary care settings in Nagpur: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuva Kapoor |
| Designation |
Principal Investigator |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Community Medicine,4th floor,Medical College Building, AIIMS NAGPUR, Plot 2, Sector 20,MIHAN ,NAGPUR
Nagpur
MAHARASHTRA
441108
India |
| Phone |
08291966736 |
| Fax |
|
| Email |
anuvakapoor19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujiv Akkilagunta |
| Designation |
PG Thesis Guide |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Community Medicine,4th floor,Medical College Building, AIIMS NAGPUR, Plot 2, Sector 20,MIHAN ,NAGPUR
Nagpur
MAHARASHTRA
441108
India |
| Phone |
08291966736 |
| Fax |
|
| Email |
sujiv.oh231@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuva Kapoor |
| Designation |
Principal Investigator |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Community Medicine,4th floor,Medical College Building, AIIMS NAGPUR, Plot 2, Sector 20,MIHAN ,NAGPUR
Nagpur
MAHARASHTRA
441108
India |
| Phone |
08291966736 |
| Fax |
|
| Email |
anuvakapoor19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuva Kapoor |
AIIMS Nagpur |
Department of Community Medicine,4th floor,Medical College Building,AIIMS Nagpur
Nagpur
MAHARASHTRA |
08291966736
anuvakapoor19@gmail.com |
| Dr Anuva Kapoor |
Rural Health Centre,AIIMS Nagpur |
Rural Health Centre, Bela,Umred Tehsil, Nagpur
Nagpur
MAHARASHTRA |
08291966736
anuvakapoor19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Salt Reduction Behavioural counselling |
The intervention group will receive behavioural counselling, a list of locally available high and low-sodium-containing food items and a pictorial pamphlet on the dietary recommendations of the National Institute of Nutrition, India, with information written in Hindi and Marathi languages.Focused group discussions will be held over a period of 3 months. Aim is to reduce daily salt intake to less than 5 grams/day. |
| Comparator Agent |
Usual diet (no salt reduction counselling) |
Participants in the comparator arm will continue with their usual diet and lifestyle, without receiving any additional structured counselling or educational material on salt reduction during the study period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The diagnosed hypertensive individuals of age group 18 years and above, receiving regular follow-up for more than 3 months, who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Bedridden patients, patients with CKD, or any other conditions where a salt-reduction diet is prescribed.
Families not providing consent to participate in the study will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes will be the changes in mean dietary intake of salt( salt intake in gram/day ). |
Baseline and 3 months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Changes in Systolic Blood Pressure and Diastolic Blood Pressure (SBP and DBP) in mm/Hg per reduced salt in gram/day.
2)Proportion of participants classified as salt-sensitive, stratified by sex (Salt-sensitive defined as a reduction of five millimetres of mercury or more in systolic or diastolic blood pressure together with a reduction of twenty millimoles per day or more in urinary sodium.) |
Baseline and 3 months post intervention |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/08/2025 |
| 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="4"
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
|
This is a randomised controlled trial to evaluate the effectiveness of a structured behavioural counselling intervention for reducing dietary salt intake among adults with hypertension attending primary health centres in Nagpur, India. The study will include sixteen clusters, with eight clusters assigned to the intervention arm and eight clusters to the control arm. Participants in the intervention arm will receive group counselling sessions, educational materials, and regular reminders to reduce salt consumption, while the control arm will receive routine care. The primary outcome is the change in mean dietary salt intake measured by 24-hour urinary sodium. Secondary outcomes include change in blood pressure and the proportion of participants classified as salt sensitive. The intervention will be implemented over three months, with outcome measurements taken at baseline and three months post-intervention. |