| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Toddlers |
|
|
Intervention / Comparator Agent
|
|
|
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. |