| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- 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 - Data are available indefinitely at (Link to be included Data).
- 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.
- 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. |