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CTRI Number  CTRI/2024/10/075472 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of improved take home foods and behaviour change intervention to improve nutritional status in children 
Scientific Title of Study   Develop and evaluate effectiveness of providing improved take home foods in combination with behaviour change intervention to improve nutritional status in children in selected districts of six states of India  
Trial Acronym  NECCTAR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun M Kokane 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Department of CFM 2nd floor Sardar Vallbhai Patel Bhavan AIIMS Saket Nagar Bhopal Madhya Pradesh 462020

Bhopal
MADHYA PRADESH
462020
India 
Phone  7773000889  
Fax    
Email  Arun_Kokane.cfm@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Arun M Kokane 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Department of CFM 2nd floor Sardar Vallbhai Patel Bhavan AIIMS Saket Nagar Bhopal Madhya Pradesh 462020


MADHYA PRADESH
462020
India 
Phone  7773000889  
Fax    
Email  Arun_Kokane.cfm@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query  
Name  Arun M Kokane 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Bhopal 
Address  Department of CFM 2nd floor Sardar Vallbhai Patel Bhavan AIIMS Saket Nagar Bhopal Madhya Pradesh 462020


MADHYA PRADESH
462020
India 
Phone  7773000889  
Fax    
Email  Arun_Kokane.cfm@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  ICMR 
Address  AIIMS Campus Temple Ansari Nagar East New Delhi Delhi 110029 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Arun M Kokane  All India Institute of Medical Sciences Bhopal  AIIMS Saket Nagar Bhopal MP 462020
Bhopal
MADHYA PRADESH 		 7773000889

arun_kokane.cfm@aiimsbhopal.edu.in 
Balmurugan Ramdass  All India Institute of Medical Sciences Bhubaneshwar  Sijua Patrapada Bhubaneswar Odisha 751019
Nuapada
ORISSA 		 8547805341

balaramdass1@gmail.com 
Zahiruddin Quazi  J N Medical College Datta Meghe Institute of Higher Education and Research Wardha  Sawangi Meghe Wardha Maharashtra 442005
Wardha
MAHARASHTRA 		 9765404065

zahirquazi@gmail.com 
M S Radhika  National Institute of Nutrition ICMR Hyderabad  Metro Station PO beside Tarnaka Osmania University Mettuguda Hyderabad Secunderabad Telangana 500007
Hyderabad
TELANGANA 		 27197421

radhika.madhari@gmail.com 
Rebecca Kurian Raj  St Johns Research Institute Bengaluru  100 Feet Rd John Nagar Koramangala Bengaluru Karnataka 560034
Shimoga
KARNATAKA 		 8049467000

rebecca@sjri.res.in 
Suparna Ghosh  The George Institute for Global Health India New Delhi  308 Third Floor Elegance Tower District Centre Jasola New Delhi Delhi 110025
Central
DELHI 		 41588091

Jerath@georgeinstitute.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
lnstitutional Human Ethics Committee  Approved 
The George Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infant and young child nutrition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Existing package of ICDS services   Existing package of ICDS services including the existing THR product and existing SBCC strategy 
Intervention  Improved package of services including improved THR product and improved SBCC strategy  The improved THR (composition, preparation, and packaging) and improved SBCC package (including the strategy, contents, delivery modality, frequency) shall be prepared and will be implemented in the intervention arm clusters during the study period. The ICDS functionaries (at selected AWCs, their supervisors, officials at district level), health functionaries and the community leadership shall be oriented on the AWC selection and implementation of the study in the selected AWC areas. The improved THR product packets shall be prepared by suitable SHG/vendor/manufacturer (to be identified, based on the composition of the improved THR finalised, cost involved and other necessary regulatory/approval requirements). The improved THR composition may differ (macro and micro nutrient according to the locally available ingredients, but the minimum criteria as per the national guideline must be met) across the sites, as developed during the Phase 1 and 2. The improved THR may be produced for each state/site by a separate manufacturer or centrally for more than one state/site, as per the finalised THR options (to be decided later). The packaging of improved THR shall be different from the existing THR packets for easy differentiation and distribution. These improved THR packets shall be supplied to the designated AWCs in the intervention arm at periodic intervals, based on the demand, supply frequency and product shelf life. The study team shall coordinate and ensure supply to the AWCs, as per the schedule. The AWC teams in the clusters will distribute the improved THR packets to the beneficiaries in the clusters. The SBCC package (the content, materials and strategy) developed based on the formative research and finalised through piloting will be implemented in the intervention clusters through the AWCs (the AWWs/AWHs, Auxiliary Nurse and Midwife (ANMs)/ASHAs and the other concerned stakeholders). The improved SBCC materials and enabling technical support shall be provided to the designated AWCs (and stakeholders) in the intervention arm by the study team.  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  36.00 Month(s)
Gender  Both 
Details  In the selected clusters (AWCs), all the age-eligible children (and their caretakers and family members) shall be eligible for the THR and SBCC package, as per the arm allocated. In each of the clusters, the AWWs and the study team shall update the eligible children list, and their AWC registration status through house-to-house visits. For the children not registered in the AWCs, the caretakers and household head shall be counselled for registration in the AWC. All the children aged 6-36 months (and their parents/caretakers) in the selected AWC area (cluster) shall be eligible for the THR and SBCC, as per the allocated arm. The number of children in the age groups of 6-36 months in the study AWC areas may vary between the clusters in the same study district and also across the study districts. 
 
ExclusionCriteria 
Details  Non-consenting, SAM and sick children will be excluded. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
• To assess the effectiveness of the intervention package integrating a combination of improved THR and improved SBCC strategy targeted at children aged 6-36 months compared to the existing THR and SBCC strategy on change in weight-for-age z score (WAZ) from baseline.   baseline 6 12 18 and 24 months  
 
Secondary Outcome  
Outcome  TimePoints 
• To assess the effectiveness of the intervention package integrating a combination of improved THR and improved SBCC strategy targeted at aged 6-36 months compared to the existing programmatic context (THR and SBCC) on
o Stunting (length /height-for-age z score, LAZ/HAZ)
o Wasting (weight-for-height/length z score, WHZ)
o IYCF practices in terms of core complementary feeding indicators, nutrient intake and minimum dietary diversity of complementary feeding among children;
o Child morbidity indicators including fever, cold/cough, diarrhea, care seeking practices and hospitalization among children.
o Caregiver knowledge, skills, practice, and behavior related to the IYCF practices with special reference to complementary feeding.
 		 baseline 6 12 18 and 24 months 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   25/10/2024 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The primary goal of this study is to develop and evaluate the effectiveness of a combined approach involving improved take-home food (THR) and socio-culturally appropriate social and behavior change communication (SBCC) interventions targeted at children aged 6 to 36 months in selected regions across six states in India. The implementation of this integrated package is likely to lead to a notable improvement in nutritional status, specifically an increase in the weight-for-age z-score by at least 0.3 standard deviations (SD) after a minimum of 18 months, compared to the existing strategies. The primary objective is to evaluate the impact of the integrated approach on the weight-for-age z-score after 18 months. Secondary objectives include assessing the current status of THR and SBCC strategies, developing a culturally appropriate intervention package, evaluating its impact on undernutrition indicators and IYCF practices, and documenting its cost-effectiveness compared to existing strategies. An exploratory cross-sectional study, participatory research, and cluster randomized trial will be employed for the study. These will be conducted in selected districts across six states: Rajasthan (North Zone), Madhya Pradesh (Central), Maharashtra (West), Odisha (East), Karnataka (South), Meghalaya (Northeast), chosen for their representation of different geographic regions and operational feasibility. 
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