| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Grade 2 and 3 malnutrition |
|
|
Intervention / Comparator Agent
|
|
|
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. |