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CTRI Number  CTRI/2024/10/076065 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 29/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Community based intervention to reduce childhood under-nutrition 
Scientific Title of Study   Community-based studies on the implementation of GOI protocol (2023) for management of malnutrition in children 
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 Prema Ramachandran  
Designation  Director Nutrition Foundation of India 
Affiliation  Nutrition Foundation of India 
Address  C 13 Qutub Institutional Area

South
DELHI
110016
India 
Phone  01141688004  
Fax  011-26857814  
Email  nutritionfoundationofindia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prema Ramachandran  
Designation  Director Nutrition Foundation of India 
Affiliation  Nutrition Foundation of India 
Address  C 13 Qutub Institutional Area


DELHI
110016
India 
Phone  01141688004  
Fax  011-26857814  
Email  nutritionfoundationofindia@gmail.com  
 
Details of Contact Person
Public Query  
Name  K Kalaivani 
Designation  Deputy Director 
Affiliation  Nutrition Foundation of India 
Address  Room No 2 1st Floor Division of Public Helath Nutrition C 13 Qutub Institutional Area

New Delhi
DELHI
110016
India 
Phone  09891568830  
Fax  011-26857814  
Email  kalaivanikrishnamurthy@gmail.com  
 
Source of Monetary or Material Support  
TATA Trust Bombay House, Homi Mody Street, Fort, Mumbai-400001. 
 
Primary Sponsor  
Name  Tata Trust (Applied for) 
Address  Bombay House, Homi Mody Street, Fort, Mumbai-400001. 
Type of Sponsor  Other [Education and Development Trust] 
 
Details of Secondary Sponsor  
Name  Address 
Nutrition Foundation of India  C13 Qutub Institutional Area Delhi 110016 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prema Ramachandran  Nutrition Foundation of India  Room No 1, 1 st Floor, Division of Public Health Nutrition C 13 Qutub Institutional Area
South
DELHI 		 01141688004
011-26857814
nutritionfoundationofindia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Nutrition Foundation of India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  apparently healthy under-five children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Month(s)
Age To  59.00 Month(s)
Gender  Both 
Details  under-five children from urban low middle income families in selected ICDS blocks in South Delhi. 
 
ExclusionCriteria 
Details  under-five children from other economic strata; children with chronic ailements. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the ongoing programme over three years in:
 Coverage under the monthly weighing and growth monitoring;
 Detection of moderate and severe under-nutrition in these communities;
 Changes in the referral of children to hospitals for severe malnutrition. 		 0, 12, 24, & 36 months 
 
Secondary Outcome  
Outcome  TimePoints 
changes in prevalence of moderate & severe stunting, underweight & wasting in under-five children in this community over the three-year period.  0, 12, 24, & 36 months 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   11/11/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Objective

To document:

Ø  the ongoing growth monitoring and detection of under-nutrition in children under the existing guidelines by the health and ICDS frontline workers;

Ø  changes over the next three years in growth monitoring and detection of under-nutrition in children as envisaged in the 2023 protocol;

Ø  changes in community-based management of child malnutrition over the next three years;

Ø  changes in referral of SAM children to hospitals for management of medical complications.

Study design

NFI had been undertaking mixed longitudinal studies on nutritional status and morbidity in a well-defined urban low middle income community for over a decade.

The ongoing data collection will provide the baseline information on socio-demographic profile of the population, morbidity and nutritional status of under-five children in this community.

Over the next three years the NFI research staff will undertake data collection on changes in the:

Ø  Coverage under the monthly weighing and growth monitoring;

Ø  Detection of moderate and severe undernutrition in these communities;

Ø  Changes in the referral of children to hospitals for severe malnutrition.

The NFI research staff will undertake anthropometric measurements once a quarter to document the changes in prevalence of stunting, underweight and wasting in children over the next three years.

Sample Size:

About 2000 under-five children will be investigated at any given time point in this mixed longitudinal study. The population is largely of families of migrant labourers and about 50% shift to other areas by 12 months. At the third year about a third of the families enrolled may be available. As some families move out others with similar sociodemographic profile move in and so there will not be any problems in having an adequate sample size in this mixed longitudinal study for the entire duration of the study.

Duration of the study: Three years

Parameters for impact assessment:

Changes in the ongoing programme over three years in:

Ø  Coverage under the monthly weighing and growth monitoring;

Ø  Detection of moderate and severe under-nutrition in these communities;

Ø  Changes in the referral of children to hospitals for severe malnutrition.

Data collection by research staff on nutritional status of under-five children once in three months will provide information on the changes in prevalence of moderate and severe stunting, underweight and wasting in under-five children in this community over the three-year period.

Policy and programme implications of the study

Data from the study will provide evidence on the feasibility and impact of the implementation of the 2023 protocol for management of malnutrition in children so that appropriate mid-course corrections in the protocol can be carried out.


 
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