| CTRI Number |
CTRI/2024/11/077423 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying how preschooler eat fruits and vegetables; looking at their habits and choices |
|
Scientific Title of Study
|
Dietary consumption pattern of fruits and vegetables in preschoolers |
| 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 Monal Velangi |
| Designation |
Senior Dietician |
| Affiliation |
K.J.Somaiya Hospital and Research Centre |
| Address |
Somaiya Ayurvihar, Ground floor, Dietetics Department, Eastern Express highway, Sion East, Sion, Mumbai Maharashtra
Somaiya Ayurvihar, Ground floor, Dietetics Department, Eastern Express highway, Sion East, Sion, Mumbai Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
09136097274 |
| Fax |
|
| Email |
dr.monalvelangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sindhu Gawas |
| Designation |
Student |
| Affiliation |
Dr Bhanuben Mahendra Nanavati College of Home Science |
| Address |
9th floor, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
9th floor, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7666230638 |
| Fax |
|
| Email |
sindhugawas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monal Velangi |
| Designation |
Senior Dietician |
| Affiliation |
K.J.Somaiya Hospital and Research Centre |
| Address |
Somaiya Ayurvihar, Ground floor, Dietetics Department, Eastern Express highway, Sion East, Sion, Mumbai Maharashtra
Somaiya Ayurvihar, Ground floor, Dietetics Department, Eastern Express highway, Sion East, Sion, Mumbai Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
09136097274 |
| Fax |
|
| Email |
dr.monalvelangi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhanuben Mahendra Nanavati College of Home Science, Mumbai, Maharashtra, India, 400019 |
|
|
Primary Sponsor
|
| Name |
Sindhu Gawas |
| Address |
Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra, India 400019 |
| 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 |
| Dr Chetna Ajmera |
Amulakh Vidyalaya |
Pre-primary section, First floor, 76-A, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
9130462048
harshadapaliwal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee (IEC) 338 R. A Kidwai Road Matunga, Mumbai 400019 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy preschool children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 3 to 5 years.
Children who are residents of Mumbai.
Children who are generally healthy no chronic illnesses that could affect their immune or digestive system, to isolate the impact of the diet on cold, cough and constipation. |
|
| ExclusionCriteria |
| Details |
Children less then 3 years or more than 5 years of age range.
Children who have not been living in Mumbai.
Children with chronic digestive conditions, diabetes, kidney, heart, TB, COPD, asthma, congenital issues. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of fruits and vegetables consumption among preschoolers |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
compare the consumption data with ICMR standards to check if child is consuming recommended amounts.
Identify the nutritional gaps that may have an impact on the growth and development of preschoolers.
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
06/12/2024 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this study is to evaluate the fruit and vegetable consumption patterns of preschool-aged children in Mumbai, India.The first objective of the study is Assessing the nutritional status of preschooler participants which involves assessing the child nutritional status using weight for age, height for age and weight for height measures. Second objective was to Understand the dietary consumption pattern of fruits and vegetables among preschool children. The purpose of this objective is to collect comprehensive data about the types and amounts of fruits and vegetables which the young children consume. Food Frequency Questionnaire is the method used to collect data and the aim is to find the patterns and possible dietary gaps in the children diet. The final objective is to compare the fruits and vegetables servings consumption with ICMR standards of the participants. ICMR has given recommendations for the daily consumption of fruits and vegetables for varying age groups. In this objective, the purpose is to compare the actual consumption data that is gathered from the participants with the standards given by ICMR to check if the child is consuming the required amount of fruits and vegetables or not. This comparison is useful in identifying the areas that require dietary interventions. The research will assess the connection between preschoolers consumption of fruits and vegetables and the occurrence of common illnesses like cold, coughs and constipation. The results of this study will add to the body of information already available on child nutrition and guide the creation of focused nutritional interventions and policies meant to enhance the eating habits of young children in India. |