| CTRI Number |
CTRI/2023/09/057249 [Registered on: 05/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To examine the relationship between parental feeding practices and children’s eating behaviors (5- 10 years) in middle socioeconomic class of Mumbai. |
|
Scientific Title of Study
|
Association between parental feeding practices and children’s eating behaviors (5- 10 years) in Mumbai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aqsa Sabban Khan |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8879876972 |
| Fax |
|
| Email |
aqsakhans2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Shekar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aqsa Sabban Khan |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd,
Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8879876972 |
| Fax |
|
| Email |
aqsakhans2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science |
|
|
Primary Sponsor
|
| Name |
Aqsa Sabban Khan |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| Aqsa Sabban Khan |
Dr. BMN College of Home Science |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
8879876972
aqsakhans2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Mothers will be approached to fill out the questionnaire.
2. Mothers with two or three children between the ages of 5 and 10 will be included.
3. Children should belong to middle socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
1. Children aged below 5 and above 10 will not be included.
2. Any disabled child or child with medical conditions will not be included.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is a marked difference between parental feeding practices & children’s eating behaviors. |
Six months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/09/2023 |
| 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="4"
Days="0" |
|
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
|
Aim: To examine the relationship between parental feeding practices and children’s eating behaviors (5- 10 years) in Mumbai.
Objectives: 1. To analyze the parental feeding practices. 2. To evaluate the children’s eating behaviors. 3. To examine the relationship between children’s eating behaviors and parental feeding practices. 4. To assess the nutritional status of a child by Food Frequency Questionnaire (FFQ). |