| CTRI Number |
CTRI/2025/02/080417 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding breastfeeding knowledge, practices, and the support in mothers of children aged 6-24 months receive in Kanyakumari |
|
Scientific Title of Study
|
Knowledge, Practice & Breastfeeding Support Among Mothers of Children aged 6-24 months in Kanyakumari: A Mixed-Method Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Smirthi C V |
| Designation |
Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Public Health
K S Hegde Medical Academy
Nithyananda Nagar, Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8496003940 |
| Fax |
|
| Email |
krishnasmirthicv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mackwin Kenwood Dmello |
| Designation |
Associate Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Public Health
K S Hegde Medical Academy
Nithyananda Nagar, Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mackwin Kenwood Dmello |
| Designation |
Associate Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Public Health
K S Hegde Medical Academy
Nithyananda Nagar, Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Monetary support- Self Funded
Material support - K S Hegde Medical Academy |
|
|
Primary Sponsor
|
| Name |
Krishna Smirthi C V |
| Address |
Department of Public Health
K S Hegde Medical Academy
Nithyananda Nagar, Deralakatte, Mangaluru, Karnataka-575018 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self sponsored |
Department of Public Health
K S Hegde Medical Academy
Nithyananda Nagar, Deralakatte, Mangaluru, Karnataka-575018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krishna Smirthi C V |
K S Hegde Medical Academy |
Department of Public Health
K S Hegde Medical Academy
Nithyananda Nagar, Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA |
8496003040
krishnasmirthicv@gmaill.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, K S Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breastfeeding mothers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
a. Mothers within the reproductive age group (15-49).
b. Mothers with multiple children aged 6-24 months living in the same household and
breastfeeding experiences for each child will be considered |
|
| ExclusionCriteria |
| Details |
a. Children having congenital anomalies, chronic illness, and caretakers other than
mothers were excluded.
b. Mothers with medical conditions affecting breastfeeding. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the level of breastfeeding knowledge and practice among mothers of children aged 6-24 months in Kanyakumari. |
To determine the level of breastfeeding knowledge and practice among mothers of children aged 6-24 months in Kanyakumari. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the types of breastfeeding support received by mothers in the community. |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="590"
Sample Size from India="590"
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)
|
03/03/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The study aims to examine the influence of breastfeeding support and knowledge on breastfeeding practices among mothers of children aged 6-24 months in Kanyakumari district, Tamil Nadu. It follows a mixed-method approach, combining a cross-sectional survey to assess breastfeeding knowledge, practices, and support with Focus Group Discussions (FGDs) to explore barriers to effective breastfeeding support. The study will be conducted in selected villages within four blocks of Kanyakumari, chosen through a cluster sampling method, with systematic random sampling used to select participants from Anganwadi center records. A total of 590 mothers will be included, based on a sample size calculation using NFHS-5 data estimating a 64% prevalence of exclusive breastfeeding. The study will use a semi-structured, validated questionnaire for quantitative data collection and FGDs for qualitative insights. Quantitative data will be analyzed using Jamovi, applying Pearson/Spearman correlation to assess the relationship between knowledge and practices, while qualitative data will be manually coded and analyzed for themes. The findings are expected to provide insights into breastfeeding behaviors, the role of community and healthcare support, and the challenges faced by mothers, ultimately informing strategies to improve breastfeeding practices and support systems in the region. |