| CTRI Number |
CTRI/2020/02/023355 [Registered on: 14/02/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Nutritional Health of Tribal Children below Five Years in Udupi District, Karnataka |
|
Scientific Title of Study
|
Assessment of Nutritional Status of Under Five Children Living in tribal Habitats of Udupi District, Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariam Sophia |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy,
Prasanna School of Public health,
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08202923157 |
| Fax |
|
| Email |
msophia77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Narayanan Vasudevan Potty |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy,
Prasanna School of Public health,
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08202923157 |
| Fax |
|
| Email |
prakash.nvp@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mariam Sophia |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Department of Health Policy,
Prasanna School of Public health,
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
08202923157 |
| Fax |
|
| Email |
msophia77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health
MAHE
Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Mariam Sophia |
| Address |
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal 576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Mariam Sophia |
Udupi district |
Rural and urban areas of Udupi district having tribal population
Udupi
KARNATAKA |
9901683220
msophia77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
Children under 5 year( 6months to 59 months)
The older child will be selected in households having more than one child |
|
| ExclusionCriteria |
| Details |
Visiting children will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will be able to estimate the nutritional status among the under 5 tribal children residing in Udupi district and identify the causes for the presence of malnutrition.
The utilization of the government scheme, Mathru Poorna will be known. |
May 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
Final Enrollment numbers achieved (Total)= "253"
Final Enrollment numbers achieved (India)="253" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2020 |
| Date of Study Completion (India) |
18/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL, as of now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Malnutrition is the most widespread condition affecting the health of children, more so among tribals. Tribal children are a neglected section of society and have very poor health indicators when compared to the rest of the population. Malnutrition in early childhood has serious long term consequences, greater risk of disease and early death. The nutritional status of children under the age of five years is considered to provide a good reflection of the nutritional health of the community, as children are most susceptible to problems of inadequate food intake and diseases, which are the immediate causes of malnutrition. Child malnutrition is recognised as an important public health indicator for monitoring nutritional status and health in populations. Data on child feeding practices will be collected using a pre- structured and pre- tested questionnaire by interviewing mothers. Dietary assessment of the child will be done using a 24-hour dietary recall method. In-depth interviews will be done with the health workers (ASHA, AWW) and the Child Development Project Officer. Focus Group Discussions (FGD) will be done with selected mothers of under five children. The study will be able to estimate the nutritional status among the under five tribal children residing in Udupi district and identify the feeding practices. The utilization of the government scheme, Mathru Poorna will be known. |