| CTRI Number |
CTRI/2026/02/103583 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Quasi-experimental study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of structured lactation education via social Media platform on maternal breastfeeding self-Efficacy |
|
Scientific Title of Study
|
Effectiveness of structured lactation education via social Media platform whatsapp on maternal breastfeeding self-Efficacy: 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 |
Dr Sanju Yadav |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pediatrics
Room No. 23, Ground floor, GIMS Hospital
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9873335473 |
| Fax |
|
| Email |
dr.sanjuyadav07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Mittal |
| Designation |
Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pediatrics
Room No. 23, Ground floor, GIMS Hospital
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7761074491 |
| Fax |
|
| Email |
mittal20007020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Mittal |
| Designation |
Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pediatrics
Room No. 23, Ground floor, GIMS Hospital
Kasna, Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
7761074491 |
| Fax |
|
| Email |
mittal20007020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, Ministry of Health and family welfare, 2nd floor, IRCS Building, 1 Red cross Road, New Delhi-110001, India |
|
|
Primary Sponsor
|
| Name |
Department of Health Research, Ministry of Health and family welfare, India |
| Address |
2nd floor, IRCS Building, 1 Red cross Road, New Delhi-110001, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research |
V.Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanju Yadav |
Government Institute of Medical Sciences (GIMS) |
Department of Pediatrics Room No. 23, Ground Floor GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH |
9873335473
dr.sanjuyadav07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Structured lactation education via social media platform(whats app) on maternal breastfeeding self efficacy |
From Baseline to End of study at end of week 8 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Primiparous
2. Healthy pregnancy and uncomplicated birth
3. No health problems preventing breastfeeding drug use etc
4. Not having any obstacle to communication.
5. Being literate understand and speak English or Hindi
6. Having a smart phone and internet connection and can use WhatsApp application.
7. Healthy and term baby, weight between 2500 to 4000 gm
8. No congenital defects oesophageal atresia, cleft palate, cleft lip etc.
9. Apgar Score more than 7 at 5 mins
10. Participants are willing to sign consent |
|
| ExclusionCriteria |
| Details |
1. Multiparous
2. Medical and obstetrical complications
3. Women with mental illness who cannot give informed consent
4. ICU admission
5. Not literate
6. Cannot use WhatsApp
7. NICU admission
8. Preterm
9. Low birth weight
10. Apgar score less than 7 at 5 mins
11. Congenital malformation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of structured lactation education via social media platform(whats app) on maternal breastfeeding self efficacy. |
From Baseline to end of study at wend of week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To assess the breastfeeding practice post intervention.
•To evaluate the participant engagement and satisfaction with social media –based lactation education programme.
|
From Baseline to end of study at wend of week 8 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/03/2026 |
| 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="3"
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 - NO
|
|
Brief Summary
|
Digital health tools are emerging as
complementary solutions to traditional services. McFadden et al. (2017) established
through a Cochrane review that structured support when initiated early can significantly improve breastfeeding outcomes [8].
A study by Yilmaz E et
al. (2021) found that WhatsApp, one of the most widely used social media
platforms in India, has shown promising results. A randomized controlled trial
revealed that WhatsApp-based lactation education and support significantly
increased maternal breastfeeding self-efficacy at both three and six months
postpartum (9)
In recent years, digital interventions—especially via
mobile phones—have emerged as effective tools. Puranki A et al (2018) In Madhya
Pradesh, a study involving weekly phone calls and daily text messages
significantly improved breastfeeding indicators (10). STUDY DESIGN: A quasi-experimental study
ETHICAL CONSIDERATIONS: Prior to
commencing the study, ethical approval will be obtained from the Institutional
Ethics Committee (IEC) of the participating tertiary care hospital.
STUDY POPULATION: The study
will be conducted in the postnatal unit of a tertiary care hospital which
provides maternal and neonatal services. Eligible participants would be primiparous women who have given birth during the study period.
SAMPLING METHOD: Quasi- Experimental Study
|