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CTRI Number  CTRI/2025/08/093763 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health education and food label training]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing health education along with giving knowledge about understanding the sugar and salt content in food container labels with only health education and also without any intervention in Helping Young children Eat Less Sugar and Salt 
Scientific Title of Study   Effectiveness of Health Education module versus Food Label Training in Reducing pre-school childrens’ Sugar and Salt Intake: A Randomized 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 Sara J Ommen 
Designation  Senior Resident 
Affiliation  Kasturba Medical College Mangalore 
Address  Department of Community Medicine, Kasturba Medical College Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09400617498  
Fax    
Email  saarahhjo10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanna Mithra P 
Designation  Professor and Head 
Affiliation  Kasturba Medical College Mangalore 
Address  Department of Community Medicine, Kasturba Medical College
Lighthouse hill road, hampankatta, Mangalore
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449243260  
Fax    
Email  prasanna.mithra@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sara J Ommen 
Designation  Senior Resident 
Affiliation  Kasturba Medical College Mangalore 
Address  Department of Community Medicine (3rd floor, administrative building)Lighthouse hill road, hampankatta, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09400617498  
Fax    
Email  saarahhjo10@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Kasturba Medical College Mangalore 
Address  Department of Community Medicine, Kasturba Medical College Mangalore, Lighthouse hill road, hampankatta, 575001 
Type of Sponsor  Private medical college 
 
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 
Dr Sara J Ommen  Kasturba Medical College Mangalore  Department of Community Medicine (3rd floor, administrative building), Lighthouse hill road, hampankatta, Mangalore
Dakshina Kannada
KARNATAKA 
09400617498

saarahhjo10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health education and/or food label training  Modular intervention for 6 months 
Comparator Agent  Standard Anganwadi services  Effectiveness of health education module and food label training is compared against standard Anganwadi services (control arm) in reducing pre-school childrens sugar and salt intake 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Mothers of children aged 3-6 years registered in the participating Anganwadi centres, Residency within the Mangalore urban area, Ability to understand and communicate in Kannada or English
 
 
ExclusionCriteria 
Details  Mothers who refuse to consent
Mothers of children with known medical conditions requiring specific dietary restrictions related to sugar and salt intake
Mothers with cognitive impairments or psychiatric illnesses that may affect their ability to understand and participate in the study
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the consumption of sugar the diet of children,
Reduction in the consumption of salt in the diet of children
 
Baseline, 3 months after intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="375"
Sample Size from India="375" 
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)   01/10/2025 
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="2"
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  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 - Data are available indefinitely at (Link to be included Data).

  6. For how long will this data be available start date provided 08-01-2027 and end date provided 08-01-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Excessive consumption of added sugars and salt among children significantly contributes to childhood obesity and related non-communicable diseases (NCDs), including hypertension, insulin resistance, and poor growth. This study aims to evaluate and compare the effectiveness of two interventions—health education alone versus health education combined with food label training—in reducing added sugar and salt intake in preschool children.

The study is an open label randomized controlled trial conducted in urban Anganwadi centers in Mangalore, Karnataka. Mothers of children aged 3–6 years will be the primary participants. The study consists of three arms: (1) Health Education Module, (2) Health Education + Food Label Training, and (3) Control group receiving standard care. A total of 21 Anganwadi centers will be randomly allocated into these groups.

The health education module will focus on the risks of high sugar and salt intake, identifying food sources, and promoting healthier alternatives. The food label training will equip mothers with skills to interpret nutritional labels and make informed food choices for their children. Data on sugar and salt intake will be collected using a culturally adapted Food Frequency Questionnaire (FFQ) at baseline and three months post-intervention.

The primary outcome is a reduction in the consumption of added sugars and salt. Data analysis will be done using SPSS, with ANCOVA used to compare outcomes across groups. The results will help determine the most effective strategy for improving children’s dietary behavior and can guide community-based nutrition interventions. Ethical approval has been obtained, and the study will adhere to all ethical standards, including informed consent and participant confidentiality.

This intervention, if effective, has the potential to be scaled through Anganwadi services to improve child nutrition and reduce long-term NCD risk in vulnerable populations.

 

 
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