| CTRI Number |
CTRI/2025/08/092800 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey Study |
| Study Design |
Other |
|
Public Title of Study
|
Breast feeding and complimentary feeding practices among Indian mothers- A survey study |
|
Scientific Title of Study
|
A survey study on breast feeding and complimentary feeding trends among Indian mothers. |
| 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 Champa Pant |
| Designation |
Professor & HOD |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
OPD no 3, Department of Kaumarabhritya, Ground Floor Sushrutha Ayurvedic Medical College and Hospital,Prashanthi kuteeram,Jodi bingipura, Jigani Hobli,Anekal Taluk,Bengaluru
Bangalore KARNATAKA 560105 India |
| Phone |
9986189230 |
| Fax |
|
| Email |
champapantdr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Champa Pant |
| Designation |
Professor & HOD |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
OPD no 3, Department of Kaumarabhritya, Ground Floor Sushrutha Ayurvedic Medical College and Hospital,Prashanthi kuteeram,Jodi bingipura, Jigani Hobli,Anekal Taluk,Bengaluru
Bangalore KARNATAKA 560105 India |
| Phone |
9986189230 |
| Fax |
|
| Email |
champapantdr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Champa Pant |
| Designation |
Professor & HOD |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
OPD no 3, Department of Kaumarabhritya, Ground Floor Sushrutha Ayurvedic Medical College and Hospital,Prashanthi kuteeram,Jodi bingipura, Jigani Hobli,Anekal Taluk,Bengaluru
Bangalore KARNATAKA 560105 India |
| Phone |
9986189230 |
| Fax |
|
| Email |
champapantdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushrutha Ayurvedic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Sushrutha ayurvedic medical college and hospital Bengalore |
| Address |
Sushrutha Ayurvedic Medical College and Hospital |
| Type of Sponsor |
Other [Private Ayurvedic medical college] |
|
|
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 Champa Pant |
sushrutha Ayurvedic Medical College and Hospital |
OPD no 3, Ground Floor Sushrutha Ayurvedic Medical College and Hospital,Prashanthi kuteeram,Jodi bingipura, Jigani Hobli,Anekal Taluk,Bengaluru Bangalore KARNATAKA |
09986189230
champapantdr@gmail.com |
| Dr Namitha Rao |
sushrutha Ayurvedic Medical College and Hospital |
OPD no 3, Department of Kaumarabhritya, Sushrutha Ayurvedic Medical College and Hospital,Prashanthi kuteeram,Jodi bingipura, Jigani Hobli,Anekal Taluk,Bengaluru Bangalore KARNATAKA |
9741209252
drnamithar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAMC&H IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breast feeding Mothers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Lactating and breast feeding mothers of babies (Day zero to two years of age |
|
| ExclusionCriteria |
| Details |
Male parent
mothers with deceased child
Mothers not consenting to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the breastfeeding practices among Indian mothers. |
1.To assess maternal knowledge and awareness regarding breastfeeding
2. To identify the common reasons for early cessation or non-initiation of exclusive breastfeeding.
3.To document the age of initiation, types, and methods of complementary feeding practices among mothers.
5. To explore sociocultural, demographic, and healthcare-related factors influencing complementary feeding practices.
5. To determine the role of healthcare professionals and family in influencing feeding choices. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trends in complimentary feeding among Indian mothers |
One year |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
01/09/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [champapantdr@gmail.com].
- For how long will this data be available start date provided 30-09-2028 and end date provided 30-09-2030?
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 survey study will be carried out among the mothers of neonates, infants and young children with an Objective of assessing current breastfeeding practices, complementary feeding trends, and awareness levels regarding breastfeeding guidelines. The tool to be used is a comprehensive questionnaire which will be filled based on the information given by lactating mothers. The collected data will be subjected to suitable statistical tools to draw inferences.
|