| CTRI Number |
CTRI/2025/11/097069 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Undernutrition Among Young Children in Kheda, Gujarat: How Common Is It and the factors responsible for undernutrition |
|
Scientific Title of Study
|
Prevalence & Risk Factors Of Undernutrition Among UnderFive Children Of Kheda District Gujarat: A Community Based Cross Sectional Study |
| 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 Rajvi Mevada |
| Designation |
1st year community medicine resident |
| Affiliation |
Dr ND desai faculty of medical science & research |
| Address |
2nd floor community medicine department, Dr NDDFMSR,nadiad, kheda
Dr ND desai medical science & research, Nadiad, Kheda
Kheda
GUJARAT
387001
India |
| Phone |
9016442724 |
| Fax |
|
| Email |
mevadarajvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divyang Patel |
| Designation |
Head of Department of community medicine |
| Affiliation |
Dr ND desai faculty of medical science & research |
| Address |
2nd floor community medicine department, Dr NDDFMSR,Nadiad, Kheda
Dr NDDFMSR ,Nadiad, Kheda
Kheda
GUJARAT
387001
India |
| Phone |
9879326874 |
| Fax |
|
| Email |
drdivpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDivyang Patel |
| Designation |
Head of Department of community medicine |
| Affiliation |
Dr ND desai faculty of medical science & research |
| Address |
2nd floor Community medicine department, Dr NDDFMSR,nadiad, kheda
Dr NDDFMSR ,nadiad, kheda
Kheda
GUJARAT
387001
India |
| Phone |
9879326874 |
| Fax |
|
| Email |
drdivpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajvi Mevada |
| Address |
Dr ND desai faculty of medical science & research, Nadiad , Kheda,387001 |
| 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 Rajvi Mevada |
Dr NDDFMSR |
3rd floor, community medicine department, Nadiad, Kheda,387001
Kheda
GUJARAT |
9016442724
Mevadarajvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr pukur thekdi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Guardians or parents will be given questionnaire of under 5 children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Children under 5 years of age.
2.Children who are residents of the selected area (rural/urban Kheda district) for at least 6 months.
3.Parents/guardians who give informed voluntary consent.
|
|
| ExclusionCriteria |
| Details |
1.Children with chronic illnesses or congenital anomalies that affect growth and nutritional status. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of undernutrition |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determinant of undernutrition |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="646"
Sample Size from India="646"
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)
|
20/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Undernutrition remains a major public health concern among under-five children in India. This community-based cross-sectional study aims to assess the prevalence and identify the associated risk factors of undernutrition among under-five children residing in Kheda District, Gujarat. Data will be collected from randomly selected households using a pre-tested questionnaire, along with anthropometric measurements to assess nutritional status as per WHO growth standards. Socio-demographic, dietary, and health-related factors will be analyzed to identify determinants of undernutrition. The study findings will help in formulating targeted public health interventions to improve child nutrition in the region.
|