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CTRI Number  CTRI/2024/10/075199 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 13/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Nutrition Education on Breastfeeding Complementary Feeding Practices among Rural Women and their impact on Nutritional Status of the Children  
Scientific Title of Study   Effectiveness of Nutrition Education on Breastfeeding-Complementary feeding practives among rural women and assessing the nutritional status of their children (0-1 Year) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Agalya E 
Designation  PhD Research Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Reg no U022300942 Department of Clinical Nutrition Faculty of Allied Science Sri Ramachandra Institute of Higher Education and Research DU Chennai
Assistant Professor Cauvery College for Women Autonomous Trichy 620018
Chennai
TAMIL NADU
600116
India 
Phone  9150183439  
Fax    
Email  agalyae@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Agalya E 
Designation  PhD Research Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Reg no U022300942 Department of Clinical Nutrition Faculty of Allied Science Sri Ramachandra Institute of Higher Education and Research DU Chennai
Assistant Professor Cauvery College for Women Autonomous Trichy 620018
Chennai
TAMIL NADU
600116
India 
Phone  9150183439  
Fax    
Email  agalyae@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Agalya E 
Designation  PhD Research Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Reg no U022300942 Department of Clinical Nutrition Faculty of Allied Science Sri Ramachandra Institute of Higher Education and Research DU Chennai
Assistant Professor Cauvery College for Women Autonomous Trichy 620018
Chennai
TAMIL NADU
600116
India 
Phone  9150183439  
Fax    
Email  agalyae@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Agalya E 
Address  Department of Clinical Nutrition Faculty of Allied Science Sri Ramachandra Institute of Higher Education and Research (DU) Chennai 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabu Saran  Trichy SRM Medical College Hospital and Research Centre  Department of Obstetrics and Gynaecolgy, Trichy SRM Medical College Hospital and Research Centre SRM Nagar Chennai Highway Irungalur Trichy
Tiruchirappalli
TAMIL NADU 		 9842780322

leptoprabhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Institute of Higher Education and Research (DU)Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy mother lactation mother and their breastfeeding practices 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group   The control group will receive standard hospital care, including one oral counselling session during the third trimester. This session will focus solely on breastfeeding techniques, without covering other aspects of nutritional intervention, such as a balanced diet (MyPlate), the importance of nutrition, lactagogues, galactagogues and hygienic practices, which will not be addressed through audio-visual aids. 
Intervention  Experimental Group   Nutrition education will be imparted to the experimental group (pregnant mothers in their third trimester) over a duration of 3 months using developed audio-visual aids and face-to-face interactions. The nutrition education content will be highlighted the nutritional aspects such as a balanced diet (MyPlate), the importance of nutrition, lactagogues, galactagogues and hygienic practices etc. The content will also be provided via social media through smartphones, along with handouts for additional reference. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  For Mothers
1.Primi gravida at third trimester
2.Absence of any maternal complications.
3.Those who are willing to participate.
4.Those who having access to smartphone
 
For Infants
1.Normal Birth weight
2.Full Term
3.Absence of any birth complications or congenital abnormalities.
 
 
ExclusionCriteria 
Details  For Mothers
1.Second & third gravida.
2.Presence of any maternal complications.
3.Those who are not willing to participate.
4.Those who are not having access to smartphone

For Infants
1.Low birth weight
2.Pre term baby
3.Presence of any complications or congenital abnormalities

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Imparting Nutrition Education among Rural pregnant mother. The improvement in knowledge on breastfeeding and complementary feeding practices (Outcome) will be assessed at baseline.   Imparting Nutrition Education among Rural pregnant mother. The improvement in knowledge on breastfeeding and complementary feeding practices (Outcome) will be assessed at baseline after 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Growth indicators of the children will be assessed, after the nutrition education, the duration of education is 12 weeks with follow up.  Growth indicators of the children will be assessed at every week & follow up to 1 year. 
After Nutrition Education the progression will be occur in growth of infant. Duration of Nutrition Education 3 Months & follow up till 1 year of infant  After nutrition education the progression will be occur in growth of the infant. The outcome will be assessed at infant up to 1 year 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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 2 
Date of First Enrollment (India)   21/11/2024 
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="1"
Months="3"
Days="1" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [agalyae@sriramachandra.edu.in].

  6. For how long will this data be available start date provided 02-08-2024 and end date provided 02-08-2026?
    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 - NIL
Brief Summary   Breastfeeding is essential and unique way of providing food to infants. Breast milk is first, natural and nutritious food for new born that promotes sensory and cognitive development as well as protect against infectious diseases. The National Family Health Survey 5 (NFHS-5) in India reported that in2019–2020, 32.1% of children under five were underweight, 19.3% were wasting, and 35.5% were stunted. In NFHS-5, 25 percent of the children in Tamil Nadu were stunted. In the same time frame, 15% of the population was squandered. Additionally, it was noted that 57% of the kids (6-59 months old) had anemia. India’s under-five death rate is currently 28/1000, with under nutrition being a major
contributing factor to this rate.
 
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