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CTRI Number  CTRI/2020/03/024183 [Registered on: 23/03/2020] Trial Registered Prospectively
Last Modified On: 09/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cluster randomised, two arm nutrition interventional study, Operational and Implementation Research]  
Study Design  Other 
Public Title of Study   Preventing poor height gain in young children by improving the present State Governments program for child nutrition  
Scientific Title of Study   Preventing infant growth faltering through improvements in the government supplementary nutrition program and growth monitoring 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anura V Kurpad 
Designation  Professor 
Affiliation  St. John’s Medical College and Hospital 
Address  Dept. of Physiology Division of Nutrition 3rd Floor St. John’s Medical College Sharjapur Road

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nirupama Shivakumar  
Designation  Paediatrician  
Affiliation  St. Johns Medical College  
Address  Division of Nutrition 3rd Floor St. Johns Medical College Sarjapur Road

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  nirupama.s@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Nirupama Shivakumar  
Designation  Paediatrician  
Affiliation  St. Johns Medical College  
Address  Division of Nutrition 3rd Floor St. Johns Medical College Sarjapur Road

Koppal
KARNATAKA
560034
India 
Phone    
Fax    
Email  nirupama.s@sjri.res.in  
 
Source of Monetary or Material Support  
Jamsetji Tata Trust Bombay House, 24 Homi Modi Street, Mumbai-400001  
 
Primary Sponsor  
Name  Jamsetji Tata Trust 
Address  Bombay House, 24 Homi Modi Street, Mumbai-400001  
Type of Sponsor  Other [Trust] 
 
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 
DrNirupama S   Div of Nutrition, St. John’s Medical College  Division of Nutrition, 314, 3rd floor, St. John’s Medical College building, Bangalore
Bangalore
KARNATAKA 		 9900070008

nirupama.s@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infants and children in the age range of 6 months to 3 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Current Nutrimix (Multigrain mix) provided by the ICDS  The multigrain mix of ICDS contains cereal, millet and pulses.Specifically, rice, ragi, bengal gram, defatted soya and groundnuts. The amount is approximately be 2 kg per month for a duration of 6 months 
Intervention  Milk based food mix   The nutritional supplement is a multigrain food based mix which will contain cereals, pulses, mainly milk powder, oil, sugar or jaggery, minerals and vitamins added. The mix is a modification of the currently delivered Nutrimix from the Integrated Child Development Services (ICDS) to the beneficiaries. The amount will approximately be 2 kg per month for a duration of 6 months 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  3.00 Year(s)
Gender  Both 
Details  Situational Analysis
1.Infants in the age range of 6months to 3years on complementary feeding.

Operational and interventional research
1. Age: healthy infants aged 6+1 month
2. Exclusively or Predominantly Breastfed
3. Consented: Understanding of the study and willingness to participate as evidenced by subject’s parents and/or legal guardian’s voluntary written informed consent and has received a signed and dated copy of the informed consent form.
4. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions. 
 
ExclusionCriteria 
Details  Situational Analysis

1. Infants with diagnosed chronic medical or surgical conditions impairing growth.
2. Infants with congenital syndromes impairing growth.
3. Infants with severe acute malnutrition.

Operational and interventional research

1. Infants with diagnosed chronic medical or surgical conditions impairing growth
2. Infants with congenital syndromes impairing growth
3. Infants with severe acute malnutrition
4. Children allergic to milk or legumes.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Anthropometry: head circumference, mid upper arm circumference, height and weight.
1. Dietary diversity  		 1.7 times during the study period (1st baseline and end of completion of every month till end line)
2.7 times during the study period (1st baseline and end of completion of every month till end line) 
 
Secondary Outcome  
Outcome  TimePoints 
Development of Growth monitoring device and app for growth monitoring  One time point 
 
Target Sample Size   Total Sample Size="636"
Sample Size from India="636" 
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)   30/03/2020 
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="2"
Months="6"
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)?  

Brief Summary   An inspection of the growth of children in the first 5 years, from findings of the NFHS-4 survey, shows that they are born with a reasonable length for age (LAZ), but then falter in growth dramatically in the first 2 years of life. This means the proportion of stunted children at birth is low but rises to about 30-40% by the end of 2 years, and after that, they remain fairly stable, with a stunting prevalence of about 30-40%. It is thus important to intervene before 2 years of life in order to prevent growth faltering rather than chase stunting when it has already occurred. The factors related to growth faltering are multifarious; nutrition and WASH are among the modifiable elements and have often been the focus of interventions to reduce stunting. Systematic reviews examining stunting as an outcome have emphasized the importance of combining nutrition-specific and nutrition-sensitive interventions to tackle the problem. In this context, optimization of complementary feeding is crucial for early life growth and development. Government programs, mainly the ICDS, are comprehensive and targets beneficiaries (pregnant, lactating women and children <6 y) to improve their nutritional status. Strengthening the nutrition-specific and -sensitive components of the program will yield additional benefits in light of the recent data available on protein quality of complementary foods in children.
Children from 6 months to 2 years receive nutrition support through the supplementary nutrition program (SNP) of the ICDS in the form of a Take Home Ration (THR). The THR includes both raw food grains (rice, wheat, mung bean and other legumes) and a multigrain mix with or without added micronutrients. The quality and/or quantity are considered poor by the demand side (community) and when assessed for macronutrient quality. It is predominantly cereal-based, has poor protein quality (unless milk protein is provided) and is particularly low in fat. A detailed analysis of the situation and improvisation of the THR might benefit efforts in the reduction of growth faltering. An intervention that focuses on growth as the primary outcome requires robust methods of growth monitoring. Although weight is regularly assessed in the ICDS program, length/height are not routinely assessed owing to the difficulty in measurement and unavailability of resources.  

A combination of interventions are planned:

-  Use of an improvised or modified THR integrated into complementary feeding

-  Regular and longitudinal growth monitoring

-  Regular feedback and alerts with a checklist-based approach to management of growth faltering

-  Regular nutrition and WASH education

The design of the intervention and their interpretation will be shared and discussed through roundtables with paediatricians and nutritionists who advise the state on THR (Food and Nutrition Board, MoWCD), with officials from concerned ministries. This will be facilitated by the involvement of the State Health University, which is closely linked to medical education, research and health policy engagement. This proposal aims to utilize learnings and efforts to produce a modified THR and a hand-held device with a monitoring app for linear growth monitoring in an intervention mode to reduce growth faltering in <2 y children, in selected districts of Karnataka. To ensure adequate uptake and utilization of learnings at the policy level, from the proposed interventions the program will engage with government pediatricians and nutritionists (through collaboration with the Rajiv Gandhi University of Health Sciences, which is the nodal Health University of Karnataka, and to which all teaching Government Hospitals are affiliated), and with the Government officials (independently and through the University, which has several links with the health system), as well as with NIN and the National Technical Board for Nutrition (NTBN) at the NITI Aayog. This is critical, so that the design of the initial evaluations, and their interpretation, are completely participatory, for subsequent leverage of findings, and stakeholder-based scale up to more districts and more states.

 
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