| CTRI Number |
CTRI/2025/03/083690 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational video intervention ] |
| Study Design |
Other |
|
Public Title of Study
|
Mobile phone-Based Counseling Intervention for
Exclusive Breastfeeding Promotion among Mothers
and caregivers in a Tertiary Care Hospital Mysuru.
|
|
Scientific Title of Study
|
Mobile phone-Based Counseling Intervention for
Exclusive Breastfeeding Promotion among Mothers
and caregivers in a Tertiary Care Hospital Mysuru:
A Quasi experimental 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 |
Harshitha Shekhar A R |
| Designation |
Student |
| Affiliation |
JSSAHER |
| Address |
JSSAHER university
Devision of JSS medical college
School of pubilc Health
srivarathrishwara nagar
bannimantap
mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
7676038262 |
| Fax |
|
| Email |
harshithashekharar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Chaitra C |
| Designation |
Assistant professor |
| Affiliation |
JSSAHER |
| Address |
Assistant professor
Department of Obstetrics and Gynaecology
JSSAHER university
JSS medical college and Hospital
srivarathrishwara nagar
Mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
9945433987 |
| Fax |
|
| Email |
drchaitrac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshitha Shekhar A R |
| Designation |
Student |
| Affiliation |
JSSAHER |
| Address |
JSSAHER university
Devision of JSS medical college
School of pubilc Health
srivarathrishwara nagar
bannimantap
mysuru
Mysore
KARNATAKA
570004
India |
| Phone |
7676038262 |
| Fax |
|
| Email |
harshithashekharar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dep of Obstetrics and Gynaecology of JSS Hospital for recruiting participantsJSS Mahavidyapeetha
Dr. Shivarathri Rajendra Circle
Mysuru – 570 004
Karnataka
India
|
|
|
Primary Sponsor
|
| Name |
Hrshitha Shekhar A R |
| Address |
Pushpagiri #2907
vijayanagar 2nd stage
mysuru |
| Type of Sponsor |
Other [The the study is not funded by any Institution it is self funded] |
|
|
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 |
| DrHarshitha Shekhar A R |
JSS Hospital |
JSS Hospital
JSS Mahavidyapeetha
Dr. Shivarathri Rajendra Circle
Mysuru – 570 004
Karnataka
India
Mysore
KARNATAKA |
7676038262
harshithashekharar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSSAHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile phone based intervention |
vedio clip which contains information regarding the exclusive breast feeding its benefis to mother and baby prepared based on WHO guidelines will be sent to the participants that is both the mothers and caregivers |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.All mothers who have given birth recently (within 5 days) only if they were accompanied by their caregivers.
2.Mothers and caregivers having access to smartphones.
3. Mothers and caregivers those who are willing to participate in the study.
intervention : mobile phone based intervention
|
|
| ExclusionCriteria |
| Details |
1. Who are unwilling to participate in the study.
2. Mothers and caregivers those who do not have access to smartphones.
3 Those who have any maternal and neonatal complications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowledge, attitude, and practices of exclusive breastfeeding analyzing the effect of intervention
Health outcome of maternal and infant
|
baseline data a
in the pretest and post test within 24hrs of intervention that is first followup
and at 3rd month which is second follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Health outcome of maternal and infant
|
baseline data
first time point: within 24 hrs
second time point : within 3 months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Mobile phone-based Counseling Intervention for Exclusive Breastfeeding Promotion among Mothers and caregiver in a Tertiary Care Hospital Mysuru: A Quasi experimental Study.
objectives:1.To assess the effectiveness of a mobile phone based counseling intervention in supporting and sustaining exclusive breastfeeding among mothers and caregivers. 2. To compare breastfeeding knowledge, attitude and practices and its perceived benefits and challenges among cases and controls. 3. To evaluate the impact of the intervention on maternal and infant health outcomes. Intervention mobile phone based intervention Outcome: Knowledge, attitude, and practices of exclusive breastfeeding analyzing the effect of intervention Health outcome of maternal and infant.
|