| CTRI Number |
CTRI/2025/02/080971 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lowering Salt in Your Diet for Staying Healthy |
|
Scientific Title of Study
|
Assessing the Impact of a Healthful Salt Measure Spoon on Salt Reduction and Taste Retention: Balancing Flavour and Health |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Sharma |
| Designation |
Assistant Professor, Community Medicine |
| Affiliation |
Govt Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Room number E-407, E block, 4th floor, Community Medicine Department, Govt Medical College and Hospital, sector 32, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
8968549054 |
| Fax |
|
| Email |
drdeepakgmch@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Deepak Sharma |
| Designation |
Assistant Professor, Community Medicine |
| Affiliation |
Govt Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Room number E-407, E block, 4th floor, Community Medicine Department, Govt Medical College and Hospital, sector 32, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
8968549054 |
| Fax |
|
| Email |
drdeepakgmch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deepak Sharma |
| Designation |
Assistant Professor, Community Medicine |
| Affiliation |
Govt Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Room number 407, E block, Community Medicine, Govt Medical College and Hospital, sector 32, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
8968549054 |
| Fax |
|
| Email |
drdeepakgmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Paryawaran Bhawan, Sector 19-B, Chandigarh-160019 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology Chandigarh |
| Address |
Paryawaran Bhawan, Sector 19-B, Chandigarh-160019 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Deepak Sharma |
Government Medical College and Hospital |
Room number 407, E block, Community Medicine, Government Medical College and Hospital Chandigarh CHANDIGARH |
8968549054
drdeepakgmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instritute Ethics Commitee GMCHChandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy people (wife and spouse in house) who are consuming more than recommended amnount of salt as tested by urine. if either or both are consuming more salt then they will be included. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
Salt reduction spoon intervention for 3 months |
A salt reduction spoon will be given to the homemaker of the family. She will be told regarding the recommended daily salt intake for her family and provided with a spoon to measure the correct amount of salt each day. The measured salt for the total family using the salt healthful salt spoon will be kept in a jar and used exclusively for cooking for the day, with any leftover salt discarded at the end of the day. Next day again she will fill the jar and use the amount of salt for that day. At regular intervals (2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks) she will be told to further reduce the amount of salt. She will accordingly measure the salt using the provides spoon and transfer to jar so that that amount can be used for the family for the day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Aged 18 years and above
Not diagnosed with hypertension
A usual resident of the study area
Usually eating at home.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Developing a Healthful Salt Measure Spoon
Change in mean salt intake after intervention.
|
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Acceptability of Salt Measure Spoon for Reducing Dietary Salt
Improvement in participants knowledge and attitudes regarding the consumption of high-salt foods post-intervention.
|
3months |
|
|
Target Sample Size
|
Total Sample Size="122" Sample Size from India="122"
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)
|
14/03/2025 |
| 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="1" Months="6" 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 - 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 - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 (Others) - written requesty by email
- For how long will this data be available start date provided 02-11-2025 and end date provided 02-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to develop a Healthful Salt Measure Spoon as an intervention to reduce dietary salt intake while maintaining taste. It also aims to establish empirical values for salt reduction that ensure taste perception remains within acceptable limits. This salt reduction spoon will be given to the homemaker of the family. She will be told regarding the recommended daily salt intake for her family and provided with a spoon to measure the correct amount of salt each day. The measured salt for the total family using the salt healthful salt spoon will be kept in a jar and used exclusively for cooking for the day, with any leftover salt discarded at the end of the day. Next day again she will fill the jar and use the amount of salt for that day. At regular intervals (2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks) she will be told to further reduce the amount of salt. She will accordingly measure the salt using the provides spoon and transfer to jar so that that amount can be used for the family for the day. We will also assess the acceptability of the Salt Measure Spoon and its influence on knowledge and attitudes regarding high-salt food consumption. A prospective before-after study design will be employed over 18 months, enrolling 122 individuals from the general population in the field practice area of the Community Medicine department, GMCH, Chandigarh. The primary outcome measure is the change in mean salt intake, estimated through urinary sodium excretion before and after the intervention (every fortnight urine will be tested and slat estriamtion done so as top know how much salt recution in diet is there. This research will provide valuable insights into effective, acceptable strategies for salt reduction and their impact on dietary behavior. |