| CTRI Number |
CTRI/2024/01/061791 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Infant and young child feeding practices among tribal mothers in The Nilgiris |
|
Scientific Title of Study
|
Enhancement of culturally acceptable infant and young child feeding practices among tribal mothers in The Nilgiris district of Tamil Nadu in line with Sustainable Developmental Goal 2. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rithu S |
| Designation |
PhD scholar |
| Affiliation |
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education |
| Address |
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08072517806 |
| Fax |
|
| Email |
rithu1.psphmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education |
| Address |
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arathi P Rao |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education |
| Address |
Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health |
| Address |
Manipal Academy of Higher Education, Manipal, Udupi, Karnataka - 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Rithu S |
Prasanna School of Public Health |
Room no. 60, Department of health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
8072517806
rithu1.psphmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tribal mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational intervention |
Short animated film on IYCF practices will be developed based on the results that will be generated from the study and will be screened to the eligible population along with a nutrition talk and a recipe book will be provided. These interventions will be delivered over a period of 15 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Female |
| Details |
Mothers of tribal children aged 0 to 23 months in The Nilgiris district of Tamil Nadu |
|
| ExclusionCriteria |
| Details |
Mothers who are unwilling to participate, those unable to participate due to physical or mental illnesses, and mothers with children having chronic illness or cognitive impairment will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| % change in knowledge, attitude and practices related to IYCF will be considered as the effectiveness of the intervention. |
Baseline knowledge, attitude and practices will be assessed at the beginning of the study from January 2024 to August 2024. These variables will be again assessed six months after the delivery of the intervention.(Intervention will be delivered from January 2025 to June 2025 & the anthropometric measurements will be taken from July 2025 to December 2025) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The nutritional status(height, weight, MUAC) of infants & young children of all the tribal
populations across the district will be estimated. |
Anthropometric measurements will be collected once before the intervention(at baseline, from January 2024 to August 2024) & once six months after delivery of the intervention(Intervention will be delivered from January 2025 to June 2025 & the anthropometric measurements will be taken from July 2025 to December 2025) |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2024 |
| 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="2"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
This study aims to develop and test an intervention to promote IYCF practices among tribal mothers in The Nilgiris district of Tamil Nadu. A survey will be conducted among tribal mothers with children aged 0 to 23 months in The Nilgiris district of Tamil Nadu to determine their level of knowledge, attitude, and practices related to infant and young child feeding. Also, key stakeholders and the mothers will be interviewed in-depth to understand their perspectives on IYCF. This data will be used to develop an educational intervention in the form of a short animated film on IYCF practices, a nutrition talk, and a tribal recipe book. These interventions will be delivered to the mothers, and their knowledge, attitude, and practices will be assessed after six months to determine the effectiveness of these interventions. |