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CTRI Number  CTRI/2021/12/039051 [Registered on: 30/12/2021] Trial Registered Prospectively
Last Modified On: 29/12/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Nutritional status and its factors among under-five children of a Koraga tribal group in Udupi district  
Scientific Title of Study   Nutritional status and its determinants among under-five children of a particularly vulnerable tribal group in Udupi district 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranjitha S Shetty 
Designation  Associate Professor and Coordinator Center for Indigenous Population 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Community Medicine Kasturba Medical College Manipal Academy of Higher Education Manipal

Udupi
KARNATAKA
576104
India 
Phone  9110401395  
Fax    
Email  ranjitha.shetty@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjitha S Shetty 
Designation  Associate Professor and Coordinator Center for Indigenous Population 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Community Medicine Kasturba Medical College Manipal Academy of Higher Education Manipal


KARNATAKA
576104
India 
Phone  9110401395  
Fax    
Email  ranjitha.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjitha S Shetty 
Designation  Associate Professor and Coordinator Center for Indigenous Population 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Community Medicine Kasturba Medical College Manipal Academy of Higher Education Manipal


KARNATAKA
576104
India 
Phone  9110401395  
Fax    
Email  ranjitha.shetty@manipal.edu  
 
Source of Monetary or Material Support  
SEED GRANT, Manipal Academy of Higher Education, Manipal-576104 Udupi District. 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education MAHE 
Address  Manipal Academy of Higher Education (MAHE) Manipal 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranjitha S Shetty   Kasturba Medical College, Manipal  Coordinator, Centre for Indigenous Population, Dept. of Community Medicine.
Udupi
KARNATAKA 
9110401395

ranjitha.shetty@manipal.edu 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  survey participants are healthy volunteer members from PVTG community of Udupi District  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Under five children and the mothers of under five children from Koraga tribe residing in Udupi
district. 
 
ExclusionCriteria 
Details  Children & mothers who are seriously ill and cannot respond to the question will be excluded
from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will help in
1. Estimating the prevalence of nutritional status among under-five children belonging to a PVTG.

2. Identifying utilization pattern of nutritional supplementation services by this vulnerable population. 
Nine months for data collection and three months for data analysis and report writing 
 
Secondary Outcome  
Outcome  TimePoints 
1.Ascertaining factors affecting nutritional status in this population

2. Planning interventions to improve the nutritional status of under-five children in this
population 
three months  
 
Target Sample Size   Total Sample Size="336"
Sample Size from India="336" 
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)   05/01/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Purpose of the study

Undernutrition among children aged ≤5years is one of the major public health problems in India and the burden is even more prevalent in tribal communities. The growth and development of under-five children mostly depend on the nutrition one has acquired during the early period of their life. Factors such as maternal nutrition, health status during pregnancy, pre-term delivery, low birth weight, faulty feeding practices, frequent respiratory or gastrointestinal infections can lead to wasting. The persistence of such a condition for an extended period of time can result in stunting.

Under-five children from tribal communities are no exception in this regard and with the prevailing low socio-economic status, lack of safe drinking water supply and poor housing conditions in the tribal communities, their children are at a higher risk of having malnutrition during their childhood and could affect their growth and development. 

As there is a dearth of published literature addressing these issues among particularly vulnerable tribal groups (PVTG) in this region, there is a pressing need to determine the prevalence of malnutrition among under-five children belonging to this community and to identify the factors associated with it. So, a community-based study has been proposed 
among Koraga population (a PVTG) residing in Udupi district.

Objectives
1. To assess the nutritional status of under-five children belonging to a PVTG in Udupi district.
2. To identify the socio-economic, cultural and health system and administrative determinants of nutritional status in this study population.
3. To assess the utilization of nutritional supplementation services with respect to mothers. and under-five children in the study population and to correlate it with the nutritional status of children.


Detailed description of Procedure

The list of eligible houses with under-five children in the Koraga community will be obtained from ITDP Office, Udupi prior to initiation of the survey. Following this, the survey team will make door-to-door visits and the purpose of their visit will be explained to the mothers of under-five children within the family. After explaining the details about the study (Participant Information sheet in local language), a written informed consent (Informed consent form) will be obtained by the mothers before recruiting them into the study. If a mother has more than one child belonging to the age group of 0 to 5 years, then all eligible children from that household will be recruited into the study.

Socio-demographic details of the household will be collected by administering a pretested, semi-structured questionnaire to the mothers of under-five children. The socio-economic status will be assessed using modified BG Prasad’s scale. Details regarding prenatal, natal and postnatal history, breastfeeding, immunization, feeding practices, health status and any infectious diseases etc. will be documented. Utilization of nutritional supplementation services provided through Integrated Child Development Services (ICDS) scheme and from ration obtained from ITDP will be queried.

Examination
Screening & examination will be carried out by the trained team members (with nursing background)
Children will be screened for iron deficiency anaemia by examining/inquiring regarding the following features:
(i) Pallor: conjunctival screening
(ii) Poor general health: history of frequent infections notably with recurrent upper respiratory tract infection, diarrhoea and other infections such as eye, ear etc.

(iii) Underweight (weight for age measurement)
(iv) Pica is defined as chronic ingestion of inedible substances such as clay/soil, etc.
(v) Worm infestation (history of perianal itching/passing worms in stools, abdominal pain)
(vi) Fever other than malaria, history of COVID etc

(vii) children will also be screened for the presence of Bitot’s spots (vitamin deficiency), cheilosis/angular stomatitis (vitamin B2 deficiency)
(viii) History of any underlying medical conditions.

Dietary assessment
Using 24 hours dietary recall method, the nutritional intake of mothers and children will be assessed with respect to calories, protein, vitamin A and iron as per National Institute of Nutrition (NIN) guidelines.

Anthropometric assessment:
The child’s weight will be measured as per WHO guidelines and the growth chart will be plotted. Anthropometric measurements such as height and weight will be documented for the mothers’ of under-five children. They will be categorized based on the BMI values as per WHO classification.


Screening for anaemia:
Haemoglobin will be estimated through the finger-prick method using a handheld portable haemoglobin meter for both mothers and children (1-5 years) at the household level. Haemoglobin levels < 11 gm/dl will be considered as the presence of anaemia for mothers and children in the age group of 12-48 months. Haemoglobin levels <11.5 gm/dl will be considered as anaemia for children aged between 49-60 months. Peripheral smears will be done using the finger-prick method for those children who are 
found anaemic.

Ethical Considerations
Permission was obtained from the Integrated Tribal Development Project (ITDP), Udupi to carry out this study among tribal populations. obtained  Institutional Ethics Committee Clearance for the study Objectives of the survey and procedure involved will be explained to the study participants (mothers) in the local language. Written informed consent will be obtained before recruiting them into the study. Privacy and confidentiality of collected information will be ensured at all levels of the study.
 
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