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CTRI Number  CTRI/2025/08/093185 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Nutrition Intervention In Pregnant Women 
Scientific Title of Study   The Role of Nutrition in Pregnant Women On Birth Weight: An Analytical cross sectional study in Community Setting 
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 Meghal Garg 
Designation  Junior Resident  
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  First Floor, Department of Community medicine, RUHS College OF Medical Sciences , Sector-11, Kumbha Marg, Pratap Nagar, Jaipur,
room number 107, residence hostel , RUHS College Of Medical Sciences
Jaipur
RAJASTHAN
302033
India 
Phone  7023110790  
Fax    
Email  meghal1097@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Vaseem Naheed Baig 
Designation  Head Of Department  
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  First Floor ,Department of Community Medicine , RUHS College Of Medical Sciences, Pratap Nagar, Jaipur, Rajasthan 302033, India
RUHS COLLEGE OF MEDICAL SCIENCES, Sector-11, Kumbha Marg, Pratap Nagar, Jaipur, Rajasthan 302033, India
Jaipur
RAJASTHAN
302033
India 
Phone  9828347157  
Fax    
Email  drvaseemnaheed@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Vaseem Naheed Baig 
Designation  Head Of Department  
Affiliation  RUHS COLLEGE OF MEDICAL SCIENCES 
Address  First Floor , Department of Community Medicine, RUHS College OF Medical Sciences, Pratap Nagar, Jaipur, Rajasthan 302033, India
RUHS COLLEGE OF MEDICAL SCIENCES, Sector-11, Kumbha Marg, Pratap Nagar, Jaipur, Rajasthan 302033, India
Jaipur
RAJASTHAN
302033
India 
Phone  9828347157  
Fax    
Email  drvaseemnaheed@gmail.com  
 
Source of Monetary or Material Support  
RUHS college of medical sciences 
 
Primary Sponsor  
Name  DR Meghal Garg 
Address  First floor , Department of Community Medicine, RUHS COLLEGE OF MEDICAL SCIENCES, jaipur 
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 Meghal Garg  RUHS   EUHS college of Medical Sciences , sector 11 , kumbha Marg, Pratap Nagar,Jaipur
Jaipur
RAJASTHAN 		 7023110790

meghal1097@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS-CMS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant women  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Pregnant women of reproductive age
Pregnant women in their first trimester
Regularly attending the antenatal care (ANC) services at the Primary Health Center (PHC)
Permanent resident of the study area.  
 
ExclusionCriteria 
Details  Plan to deliver outside the study area .
Diagnosed with any special medical conditions like diabetes mellitus, hypertension, severe anemia , renal disease, malignancy, cardio-pulmonary disease, ante partum hemorrhage, hypo-hyperthyroidism, epilepsy and multiple pregnancy that may impact on their ability to participate in the study.
Pregnant women who are not willing to give informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
the birth weight measure of newborn   within 72 hours after the birth  
 
Secondary Outcome  
Outcome  TimePoints 
assess the effect of nutrition intervention on the maternal knowledge, dietary practice & hemoglobin level   within 72 hours after the birth except the Hemoglobin level which will be estimated at the end of third trimester.  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - Informed Consent Form

  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 - Proposals should be directed to [meghal1097@gmail.com].

  6. For how long will this data be available start date provided 16-06-2025 and end date provided 16-06-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

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

The study to determine the Role of nutritional education intervention in pregnant women on birth weight ,in Jaipur district of Rajasthan is imperative on multiple fronts. It represents a crucial step in fulfilling our social responsibility towards one of the most vulnerable populations in society. Pregnant women are often found to have incomplete knowledge about adequate nutrition, predisposing them and their newborns to various health issues. Providing them nutritional education to improve their and their newborns nutritional status in the local context of Jaipur is essential for developing new programs and policies to improve their well-being. Moreover, the study addresses a significant research gap, as there are limited existing literatures focusing specifically on providing nutrition education to this population in the region. By conducting this study, we not only contribute to the knowledge on vulnerable populations but also advocate for the health equity and humanitarian principles that every pregnant women deserves access to balanced diet to give rise to a healthy offspring.

AIM: 

The Aim of this study is to Determine the Role of Nutrition education  Intervention in Pregnant women on Birth weight of Newborn in Community based setting of Jaipur district.

Primary Objectives:

1.         To Estimate the effect of  Nutrition education  intervention  in  Pregnant women on Birth weight in Jaipur district 

Secondary Objectives:

1.      To Determine the effect of Nutrition Intervention on Nutrition Knowledge of the Pregnant women.

2.      To Assess the effect of the Intervention on Dietary practice of the pregnant women.

  To Assess the effect of the Intervention on Hemoglobin level of the pregnant women.

Study type: Community based study

Study design: Quasi Randomized control trail with two parallel arm (intervention arm will receive nutrition intervention and other arm will receive standard care)

Study area: The study will be conducted in designated areas of Jaipur, we will choose four PHCs that are  selected by simple random sampling technique.

  PRIMARY OUTCOME: The primary outcome of the study will be the birth weight measure of newborn between the intervention and control group.

SECONDARY OUTCOME: The secondary outcome of the study will be to assess the effect of nutrition intervention on the maternal knowledge, dietary practice  and hemoglobin level  at the start of the study till the end, and between the intervention and control group . 
 
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