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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details  non consenting 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  written requesty by email

  6. 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.

  7. 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.

 
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