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CTRI Number  CTRI/2025/03/082629 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 16/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Breastfeeding Help and Support for Your Baby 
Scientific Title of Study   Breastfeeding Education Support Tool for Baby: BEST4BABY Study 
Trial Acronym  BEST4BABY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niranjana S Mahantashetti 
Designation  Principal and Professor of Pediatrics 
Affiliation  Jawaharlal Nehru Medical College 
Address  JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  08312471350  
Fax  08312470759  
Email  niranjanasn@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology and Principal Investigator 
Affiliation  Jawaharlal Nehru Medical College 
Address  Womens and Childrens Health Research Unit, 1st floor, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax    
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology and Principal Investigator 
Affiliation  Jawaharlal Nehru Medical College 
Address  Womens and Childrens Health Research Unit, 1st floor, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448126371  
Fax    
Email  sgoudar@jnmc.edu  
 
Source of Monetary or Material Support  
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), P.O. Box 3006, Rockville, MD 20847, USA 
 
Primary Sponsor  
Name  Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD 
Address  The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), P.O. Box 3006, Rockville, MD 20847, USA 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niranjana S Mahantashetti  Jawaharlal Nehru Medical College  Department of Pediatrics, Ground Floor, JNMC Campus Nehru Nagar 590010 Belagavi
Belgaum
KARNATAKA 		 08312444190

niranjanasn@yahoo.com 
Dr Ramesh Pol  S N Medical College and HSK Hospital and Research Centre  Department of Pediatrics, Ground Floor, Navanagar Bagalkot 587102
Bagalkot
KARNATAKA 		 9945308081

rameshpol@ymail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SNMC, BAGALKOT  Approved 
Institutional Ethics Committee, KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women and the women who delivered a live baby 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Arm  Participants in the control clusters will continue with local practice for antenatal breastfeeding support and referral to facilities. It is expected that they will receive routine health education recommended by the national health system during the prenatal and postnatal period and offered through PHC and community level workers, including ASHAs. ASHAs may visit a woman after delivery to provide lactation support, as needed, with visits ceasing at 42 days post-delivery.  
Intervention  Intervention Arm  participants in the intervention clusters will receive BEST4Baby, a theory-based, breastfeeding education and support intervention that spans the perinatal period from the 3rd trimester to 12 months post-delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) At least 18 years of age
2) Pregnant and having reached 20-27 weeks of gestation at study enrollment
3) Singleton pregnancy with no major antepartum complications
4) Living in a research area site
5) Planning to deliver in the cluster area
6) Capable of giving informed consent
7) Willing to be visited by peer counselors and research personnel for up to 12 months post-delivery 
 
ExclusionCriteria 
Details  1) Comorbidities impacting breastfeeding
2) Severe psychological illness that could interfere with consent and study participation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Aim 1

EBF at 6 months: proportion of infants exclusively breastfed at 6 months, as measured with the infant feeding behavior questionnaire. EBF will be defined as receiving breast milk as the only source of nourishment for the first 6 month of life, except for oral rehydration solution, vitamins, medicines)

Aim 2

Infant growth velocity: mean change in length from birth to 6 months, and birth to 12 month. Length at the 3 day and the 6 month and 12 month study visits will be used

Infant cognitive development: mean BSID-IV cognitive domain scores at 12 months.
 		 6 months after delivery, 12 months after delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Infant feeding behaviors: measured with infant feeding behavior questionnaire
 		 3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery 
Maternal infant feeding knowledge, attitudes, and self-efficacy: mean scores on infant feeding knowledge items, the IIFAS, and the BSES-SF at baseline, 6 and 12 months; mean changes in scores from baseline to 6 and 12 months.  3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery 
Infant health: measured with infant morbidity questionnaire  3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery 
Infant weight: mean change in weight from birth to 6 months, and birth to 12 months. Weight at 3 day, 6 month, and 12 month study visits will be used.  3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery 
Infant language, motor, social-emotional and adaptive skill development: mean BSID-IV language, motor, social-emotional and adaptive skill domain scores at 12 months.  12 months after delivery 
 
Target Sample Size   Total Sample Size="1152"
Sample Size from India="1152" 
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)   02/05/2025 
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="5"
Months="0"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  By personal mail to the study investigators: Dr Shivaprasad S Goudar(sgoudar@jnmc.edu)

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 31-05-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nill
Brief Summary  

Optimal infant feeding practices play a critical role in determining the nutritional status, health, growth, and development of children. Exclusive breastfeeding (EBF), defined as breast milk as an infant’s only intake, is a global child health survival strategy for infancy and early childhood. Despite the significant positive results of this natural intervention, a large portion of the world’s infants, including those in India, lack the benefits of EBF and other optimal breastfeeding practices. In India, nearly half of women do not follow the World Health Organization (WHO) recommendation of EBF for 6 months. Given that inappropriate feeding practices may have considerable adverse implications for infant growth, development, morbidity and mortality, efforts to increase EBF and other optimal infant feeding practices in India are needed.

Globally, interventions for EBF promotion have been implemented using different approaches. Peer counselor and mobile health (mHealth) programs are promising strategies to improve maternal infant feeding behaviors in low-income and middle-income countries (LMICs). There is insufficient evidence, however, that mHealth-supported peer counseling breastfeeding interventions significantly improve such behaviors of mothers in India, a country with the largest number of deliveries worldwide. Moreover, the impact of such interventions on infant clinical outcomes, including infant growth and development, remains unknown.


The long-term objectives of the BEST4BABY Study are to improve the infant feeding practices of mothers in India, and thus the health of mothers and infants and growth and development of infants. Widespread implementation of an effective infant feeding intervention has a great potential benefit to individual patients as well as the medical care system. Results of this study will have implications for future adoption and implementation of BEST4Baby nationally and in other low resources settings, and will be relevant, not only to the mothers in India, but to mothers in other LMICs, and the practitioners, policymakers, and healthcare systems that serve this population

 
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