| CTRI Number |
CTRI/2024/06/068434 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Nutritional Status and Cognitive Development of Pre-School Children |
|
Scientific Title of Study
|
A Comparative Study on Nutritional
Status and Cognitive Development of Pre-School Children (3-5 years) Studying in Schools
of Varanasi City |
| 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 Sukanya Chakravorty |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Home Science Mahila Mahavidyalaya Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8005231237 |
| Fax |
|
| Email |
su.chakravorty@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Chakravorty |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Home Science Mahila Mahavidyalaya Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8005231237 |
| Fax |
|
| Email |
su.chakravorty@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Neelam |
| Designation |
Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Home Science Mahila Mahavidyalaya Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9721309418 |
| Fax |
|
| Email |
paswanneelam108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 221005 |
| Department of Psychology, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 221005 |
| Prasad Psycho Corporation
J- 1/58, Daranagar, Varanasi-221001, Uttar Pradesh, India |
| UGC-NET and Junior Research Fellowship (JRF), University Grants Commission (UGC)
Bahadur Shah Zafar Marg,
New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Dr Sukanya Chakravorty |
| Address |
Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi, Uttar Pradesh, 221005 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Supervisors of Anganwadi Centres |
Anganwadi Centres |
10 wards selected for the study and Anganwadi Centres will be selected from the particular area. These are Sunderpur, Newada, Lahartara, Nagwa, Shivpur, Bangalitola, Konia, Khajuri,Ranipur, Durgakund.
Varanasi
UTTAR PRADESH |
-
neelampaswan@bhu.ac.in |
| Principals of Private Schools |
Private Schools |
10 wards selected for the study and Schools will be selected from the particular area. These are Sunderpur, Newada, Lahartara, Nagwa, Shivpur, Bangalitola, Konia, Khajuri,Ranipur, Durgakund.
Varanasi
UTTAR PRADESH |
-
neelampaswan@bhu.ac.in |
| Sukanya Chakravorty |
Varanasi City |
Government Schools (Anganwadi Centers) and Private Schools of Varanasi
Varanasi
UTTAR PRADESH |
8005231237
su.chakravorty@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Child Development Project Officer (CDPO), Varanasi |
Approved |
| District Programme Officer (DPO), Varanasi |
Approved |
| Ethics Committee, Institute of Science, Banaras Hindu University |
Approved |
| Permission Letters of Private Schools of Varanasi City |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-School Children (3-5 years) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Pre- School Children who are studying in schools of Varanasi City.
Malnourished children with poor cognitive development status. |
|
| ExclusionCriteria |
| Details |
Below 3 years of Pre-School Children
Above 5 years of Pre-School Children |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Make parents aware regarding diet management and their impact on cognitive development, by which the malnutrition lining can be reduced in the children.
Make aware the role of nutrition and balanced dietary intake in cognitive development. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Make aware the role of nutrition & balanced dietary intake in cognitive development.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="896"
Sample Size from India="896"
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)
|
20/06/2024 |
| 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="1"
Months="0"
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
|
Sound nutritional status has a profound impact on the overall as well as the cognitive development of the children. Poor nutritional status delays the children’s cognitive development. Thus, the present study included children between 3-5 years pre-school children of government schools (Anganwadi centers) and private schools of Varanasi City. The main objective of the study is to find association between nutritional status and cognitive development of children. |