CTRI/2017/08/009260 [Registered on: 03/08/2017] Trial Registered Retrospectively
Last Modified On:
23/11/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive Other (Specify) [Fortified Food product supplementation]
Study Design
Cluster Randomized Trial
Public Title of Study
Dharavi Nutrition Project
Scientific Title of Study
A Prospective randomized controlled study to evaluate the efficacy of indigenously made fortified complementary food in children with Moderate Acute Malnutrition
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Alka Jadhav
Designation
Professor
Affiliation
Lokmanya Tilak Municipal General Hospital
Address
Room No. 120/ 1st floor, Department of Pediatrics, College building, Lokmanya Tilak Municipal General Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022 Room No. 120/ 1st floor, Department of Pediatrics, College building, Lokmanya Tilak Municipal General Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022 Mumbai MAHARASHTRA 400022 India
Phone
9769765309
Fax
Email
nrrcproject@gmail.com
Details of Contact Person Scientific Query
Name
Dr Alka Jadhav
Designation
Professor
Affiliation
Lokmanya Tilak Municipal General Hospital
Address
Room No. 120/ 1st floor, Department of Pediatrics, College building, Lokmanya Tilak Municipal General Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India
Phone
9769765309
Fax
Email
nrrcproject@gmail.com
Details of Contact Person Public Query
Name
Dr Alka Jadhav
Designation
Professor
Affiliation
Lokmanya Tilak Municipal General Hospital
Address
Room No. 120/ 1st floor, Department of Pediatrics, College building, Lokmanya Tilak Municipal General Hospital, Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Mumbai MAHARASHTRA 400022 India
Phone
9769765309
Fax
Email
nrrcproject@gmail.com
Source of Monetary or Material Support
Tata Centre for Technology and Design (TCTD), IIT-Bombay
Lecture Hall Complex, Infinite Corridor, Academic Section, IIT Area, Powai, Mumbai, Maharashtra 400076
Patient should be Moderately Acute Malnourished according to Weight for Height or MUAC,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Indigenously prepared fortified complementary food products were given based on the age group
a. 6 months to 2 years
Ready to eat: Multigrain flour paste
Ready to cook: Ladoo Premix, Upma Premix, Kheer Premix , Ragi Lapsi Premix, Wheat payasam Premix
b. 2 years to 5 years
Ready to eat: Multigrain flour paste ,Nankhatai, Mathari, Shakarpara
Ready to cook: Ladoo Premix, Upma Premix , Zunka Premix
Micronutrient fortified Take Home Ration (Given by ICDS Maharashtra)
As per ICDS protocol THR is given to children between 6 months to 3 years of age and severely underweight children above 3 years of age. However, our project focuses on children in the age group of 6 months to 5 years, so ICDS Dharavi was requested to provide THR even to enrolled MAM children above 3 years of age.
Chickpea based Take Home Ration (Ingredients: wheat, chickpea, sugar), Soya and peanut based Take Home Ration (Ingredients: wheat, soyabean chunk, groundnut, jaggery)
Inclusion Criteria
Age From
6.00 Month(s)
Age To
5.00 Year(s)
Gender
Both
Details
1. Child should fall in MAM category
2. Child should not have any major illness
3. Child’s age should be between 6 months to 5 years
ExclusionCriteria
Details
1. If the child is SAM/Normal
2. Child with any major illness such as Tuberculosis, Down’s syndrome, Heart disease etc.
3. Child below 6 months of age and more than 5 years of age.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Improvements in weight, height and MUAC in intervention group as compared to the control group and consequent shift/transition of children from MAM to Normal category
Anthropometric measurements would be done at the time of enrollment, at the end of supplementation (3rd month) and at the end of 3rd month of follow up (6th month) at NRRTC, Chota Sion hospital
At community level, weight and MUAC would be measured weekly while height will be measured fortnightly
Secondary Outcome
Outcome
TimePoints
1. Understanding the prevalence of Malnutrition in the community (Dharavi)
2. Understanding the correlations between various factors such as socio economic status, educational status, birth history, immunization, feeding pattern etc with the health status of children.
At the beginning and at the end of the study.
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "324" Final Enrollment numbers achieved (India)="324"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
1. Motivation of the study:
The burden of malnutrition on children results in hampering their ability to learn and thrive. Being born as a low birth weight baby increases the risks of death in early months/years, thus necessitating an effective intervention. Conditions such as underweight, wasting (acute malnutrition), and stunting (chronic malnutrition) often go undetected, especially in urban settings where dietary patterns and accessibility to food are different from that of rural areas.
Our main objectives to carry out a project are as follows:
• Fostering an environment in areas like Dharavi for making nutrition related habits a priority
• Creating evidence through impact assessment of indigenously made micronutrient fortified food item in recovering children from MAM
• Adopting to food types familiar to local community
• Using low cost ingredients while adhering to recommended dietary allowance (RDA) and WHO guidelines.
• Generating awareness about diet diversity among mothers through nutrition counseling
• Testing importance of community level interaction
• Validating the “academia-government-medical-NGO†partnership model for CMAM initiatives as a solution for urban malnutrition.
2. As the project involves participation from children and households, all regulatory approvals concerning quality of food products and methodology related tasks were procured. The ethics committee or LTMGH, Sion, reviewed the project proposal and granted clearance for the entire study duration.
3. Sampling technique
Clustering of Anganwadis (AW):The 300 Anganwadis under ICDS Dharavi area were divided into 19 clusters based on geographical proximity. Each cluster had approximately 12-15 AWs.
Randomization of AWs into T and C group: Randomization was conducted at two levels to minimize bias in sample selection. In the first step, the clusters were randomized into Treatment (T) and Control (C) clusters using computer generated random numbers. In the second step, the AWs in the randomly selected T and C clusters were further subjected to randomization using the same method.
Phase wise distribution of study: For convenience in implementation, the entire study was carried out in three phases. Each Phase included 3 clusters each from the randomly selected T and C groups, except in Phase 3 wherein 4 clusters were included in T group.
4. Screening and Recruitment of the children:
-All children in the selected T and C anganwadi’s were screened by the respective anganwadi workers for height, weight and MUAC. Based on screening identified MAM children were referred to NRRTC, Chota Sion hospital for further assessment by medical team and possible enrollment in the project.
-After confirming the child as MAM (by the medical team) informed consent is taken and the child is enrolled in the study.
-If the child comes in treatment anganwadi , he/she receives intervention food and if the child comes in control anganwadi, he/she receives ICDS THR.
-The total duration of the project is 6 months wherein the child receives the supplementation for a period of 3 months and is followed up for 3 months after supplementation in both the groups.
-In this project data on socio economic status, feedback regarding food supplemented and anthropometric measurements was collected.