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CTRI Number  CTRI/2018/08/015408 [Registered on: 23/08/2018] Trial Registered Prospectively
Last Modified On: 27/08/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Nutrition problem in children and its relation to alcoholism 
Scientific Title of Study   Childhood Malnutrition and Paternal Alcohol Consumption 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shylaja Devi Menon 
Designation  Director 
Affiliation  ASHWINI Gudalur Adivasi Hospital 
Address  Gudalur Adivasi Hospital, Kotharvayal, Gudlaur

The Nilgiris
TAMIL NADU
643212
India 
Phone  9443931108  
Fax    
Email  nkshyla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shylaja Devi Menon 
Designation  Director 
Affiliation  ASHWINI Gudalur Adivasi Hospital 
Address  Gudalur Adivasi Hospital, Kotharvayal, Gudlaur


TAMIL NADU
643212
India 
Phone  9443931108  
Fax    
Email  nkshyla@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shylaja Devi Menon 
Designation  Director 
Affiliation  ASHWINI Gudalur Adivasi Hospital 
Address  Gudalur Adivasi Hospital, Kotharvayal, Gudlaur


TAMIL NADU
643212
India 
Phone  9443931108  
Fax    
Email  nkshyla@gmail.com  
 
Source of Monetary or Material Support  
Centre for Global Health Development 
 
Primary Sponsor  
Name  Centre for Global Health Development 
Address  3rd Floor, 801 Massachusetts Avenue, Boston, Massachusetts 02118, U.S. 
Type of Sponsor  Research institution 
 
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 Shylaja Devi Menon  ASHWINI Gudalur Aivasi Hospital  Gudalur Adivasi Hospital Door No. 10/147 G2, G3 Kotharvayal, Gudlaur- 643212
The Nilgiris
TAMIL NADU 
9443931108

nkshyla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ASHWINI IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Grade 2 and 3 malnutrition 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Belonging to the adivasi community
Weight for age below 2SD on two separate measures at least 3 months apart 
 
ExclusionCriteria 
Details  Low birth weight, <2500 g at birth
Weight for age > 3SD, at one out of 2 measurements 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the association between childhood malnutrition and paternal alcohol consumption  September 2018 to December 2018 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the association between maternal depression and childhood malnutrition.  September 2018 to December 2018 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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
Modification(s)  
N/A 
Date of First Enrollment (India)   03/09/2018 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Malnutrition is a critical determinant of morbidity in children in resource-poor countries. 45 % of all deaths in children under five years of age are associated with malnutrition. The ASHWINI health network has worked with the Adivasis (indigenous people) of Tamil Nadu, India, for over 30 years, but has observed an increase in under-5 severe malnutrition from 3% to 8 % since 2005. The rise is alarming, given that the childhood malnutrition rate reduced from 25 % to 2% between 1990 and 2005, with systematic community-based interventions. Alcohol consumption has risen 15% annually since 2005 in Tamil Nadu, in parallel with the rise in malnutrition.The prevalence of moderate-severe depression among Adivasi women is upwards of 20 %. Anecdotal evidence suggests that male alcohol consumption contributes to depression among Adivasi women. Furthermore, we believe that maternal depression may be a contributor to childhood malnutrition. We present a case-control study, quantifying alcohol paternal alcohol consumption among Adivasi men with the standardized AUDIT questionnaire, and maternal depression using the PHQ-9 questionnaire, in both cases and matched controls, using the existing system of community health workers, to gather the data. Demonstrating an association would help redesign intervention measures and influence government policy on tackling the alcohol abuse and mental health epidemic.

 
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