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CTRI Number  CTRI/2018/07/015110 [Registered on: 30/07/2018] Trial Registered Prospectively
Last Modified On: 26/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship of food habits and growth among children (1-3 years old) 
Scientific Title of Study   Assessment of factors affecting food habits and its relationship with anthropometric indices among toddlers (1-3 years) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swapna Moolya 
Designation  M. Sc. DAN 2nd year 
Affiliation  Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education 
Address  Department of Allied Hospitality Studies Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka 576104, India Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9689873490  
Fax    
Email  swapnamoolya123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pallavi G Shettigar 
Designation  Assistant Professor - Selection Grade 
Affiliation  Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education 
Address  Department of Allied Hospitality Studies Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka 576104, India Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9591273054  
Fax    
Email  pallavi.wgsha@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Kiranmayi Gudela 
Designation  Student 
Affiliation  Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education 
Address  Department of Allied Hospitality Studies Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka 576104, India Udupi KARNATAKA 576104 India

Udupi
KARNATAKA
576104
India 
Phone  7306298748  
Fax    
Email  kiranmayigudela@gmail.com  
 
Source of Monetary or Material Support  
Pallavi G Shettigar Assistant Professor Selection Grade M.Sc. Dietetics and Applied Nutrition, Department of Allied Hospitality Studies, Welcomgroup Graduate School of Hotel Administration Manipal, Udupi, Karnataka 576104 
 
Primary Sponsor  
Name  Swapna 
Address  Student, M.Sc. Dietetics and Applied Nutrition, Department of Allied Hospitality Studies, Welcomgroup Graduate School of Hotel Administration, Manipal 576104 
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 
Swapna  Welcomgroup Graduate School of Hotel Administration  Department of Allied Hospitality Studies Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education,Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA 
9689873490

swapnamoolya123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Toddlers 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  3.00 Year(s)
Gender  Both 
Details  1. Toddlers of age 1-3 years
2. Toddlers without any disease
3. Willingness of parents
 
 
ExclusionCriteria 
Details  1. Toddlers of age <1 years-> 3 years
2. Toddlers with disease (cleft lip, cleft palate)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessing the relationship between food habits and anthropometric indices among toddlers  Single interaction 
 
Secondary Outcome  
Outcome  TimePoints 
Assessing the factor affecting food habits among toddlers  Single interaction 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   30/07/2018 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

   Participants are recruited from RMCW homes and Anganwadi. During the first visit consent form will be taken, data  will be collected by the investigator using a semi structured  validated questionnaire about diet, 24 hour diet recall, socio demography, food frequency, anthropometric measurements (height, weight, MUAC)  medical history, immunization status and questions pertaining to factors related to parent/caregivers nutritional knowledge, preschool healthcare influence, parenting style and  feeding practices, IYCF practices, child preferences and likes. The toddlers and parents would be met once, to collect the required data. An education material will be provided that will explain about the  recipes, dietary tips,  behavioral modification , developmental milestones in  toddlers  which would be given to  mothers which would help them  to understand and modify the factors to enable their child to reach their developmental milestones.There are several factors  which affects the dietary  intake in toddlers such as, taste and preference attitude, likes and dislikes towards food/beverage  consumption  or difficult eating or fussy eating and also the parents nutritional knowledge and feeding attitudes . Therefore we would assess these factors and its relationship with anthropometric indices among toddlers. 

  

 
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