FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057295 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 02/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Understanding how different cultural practices, lifestyles, personal backgrounds, and knowledge about weight affect pregnant and new mothers. 
Scientific Title of Study   Interaction between cultural practices, lifestyle practices and socio-demographic determinants and weight literacy among pregnant and postpartum women. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjaly Babu 
Designation  Student 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, First floor, Chanakya -2, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8330807602  
Fax    
Email  anjaly.wgshampl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Pallavi Mahesh Shettigar 
Designation  Course Coordinator 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, First floor, Chanakya -2, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9591273054  
Fax    
Email  pallavi.wgsha@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Pallavi Mahesh Shettigar 
Designation  Course Coordinator 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, First floor, Chanakya -2, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9591273054  
Fax    
Email  pallavi.wgsha@manipal.edu  
 
Source of Monetary or Material Support  
Department of OBG, Kasturba Hospital, Manipal, Udupi KARNATAKA, 575119  
 
Primary Sponsor  
Name  Anjaly Babu 
Address  Department of Dietetics and Applied Nutrition, First floor, Chanakya -2, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Self fund] 
 
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 Sujatha B S  Kasturba Hospital  Dept of OBG, 1, ground floor, Kasturba hospital, Manipal.
Udupi
KARNATAKA 		 8660778169

bs.sujata@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 ( Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant and Postpartum Females 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant and Postpartum Females. 
 
ExclusionCriteria 
Details  Women of reproductive age who are not conceived. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the relationship between cultural and life style practices, socio demographic determinants and weight literacy among pregnancy & post partum weight.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Level of Literacy on wt management among pregnant & post partum women  baseline 
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
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)   12/09/2023 
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="0"
Months="9"
Days="24" 
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 - NO
Brief Summary   Malnutrition is considered as major risk for the life. One of the major reasons for women to fall into the category of overweight and obesity is due excessive weight gain during pregnancy and post partum. Pregnancy and post partum is known to be a significant phase is Indian culture. Certain traditions and practices are followed during this period in which some of the practices can harm the health of the women. By the end of the study we will be able to know the cultural practices, life style, socio demographic determinants  that affect  pregnancy and post partum weight.   The objectives of the study is to identity cultural practices ,life style practices and socio demographic determinants that affect pregnancy and post partum weight and to study the relationship between selected determinants and weight literacy among pregnant and post partum women. The departments involved in the study are Department of dietetics and Applied Nutrition, WGSHA, Manipal Health Literacy Unit, Prasanna School of Public Health. Sample  size for the study is 224. inclusion criteria -pregnant and post partum  women from delivery till one year. Exclusion criteria - Women of reproductive age who are not conceived. Tools used are Questionnaire related to socio demographic, cultural practices pertaining to pregnant and post partum women, life style practices like physical activity , smoking ,alcohol and 3 day dietary recall. For measuring the anthropometry Stadiometer for height and weighing scale for weight are used. To measure body composition , BIA Smart Scale pro max is used. Weight Literacy scale(Wang et al.,2018) is used for analyzing the individual’s  capacity to obtain information and skills specific to management for weight loss or gain. Biological material is not required.
Procedure/ processes - After ethical clearance, sample is selected based on the inclusion and exclusion criteria and participant’s consent .The  enrolled participants will be requested to fill the above mentioned questionnaire. Then anthropometry measures  of the participants will be taken using appropriate tools. While taking body measurements, participant’s privacy will be taken in consideration without compromise. At the end of the study, all the participants will be given a educational aid.
 
Close