Plain English Summary
Background and study aims
Globally, India suffers from the greatest burden of malnourished children. Supplementing centralized inpatient models of care with community-based models can allow for a greater number of vulnerable children to be treated for acute malnutrition cost-effectively. Children living in urban informal settlements experience similarly high levels of acute malnutrition as rural children. SNEHA (Society for Nutrition, Education and Health Action), a Mumbai-based non-profit organization, aims to implement a Community-based Management of Acute Malnutrition (CMAM) program, in partnership with the Government of India (GOI) Integrated Child Development Services (ICDS) scheme. The aim is to reduce the prevalence of acute malnutrition among children under age three living in informal settlements of Mumbai, India.
Who can participate?
Children under the age of three living in informal settlements and residing in the ICDS program service areas
What does the study involve?
In the intervention areas, a minimum of 10,000 children are expected to participate in the CMAM activities with about 2,000-3,500 children and their caregivers completing surveys at the start and the end of the study. The CMAM activities include screening for acute malnutrition, growth monitoring, home-based counselling, medical screenings, vaccination updates, and referrals to public health facilities such as a municipal nutrition rehabilitation center. In the comparison areas the children receive routine ICDS services, and about 2000 children complete surveys at the start and the end of the study.
What are the possible benefits and risks of participating?
Participants in the intervention areas receive the benefit of being screened and monitored on their nutritional status. Caregivers of malnourished children receive additional benefits of home-based counselling and medical screenings. Some children experiencing malnutrition receive ready-to-use therapeutic foods; there may be some side effects such as diarrhoea which will be monitored by the SNEHA doctors.
Where is the study run from?
Society for Nutrition, Education and Health Action (SNEHA) (India)
When is the study starting and how long is it expected to run for?
November 2011 to March 2017
Who is funding the study?
1. Forbes Marshall Foundation
2. EPIC Foundation
Who is the main contact?
Dr Anuja Jayaraman
Trial website
Contact information
Type
Public
Primary contact
Dr Anuja Jayaraman
ORCID ID
http://orcid.org/0000-0002-7269-2099
Contact details
Behind Building no. 11
BMC Colony
Shastri Nagar
Linking Road Extension
Santa Cruz West
Mumbai
400054
India
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
-
Study information
Scientific title
In urban informal settlements, can a Community-based Management of Acute Malnutrition (CMAM) approach, integrated with public health systems, reduce prevalence of acute malnutrition rates among children under the age of three?
Acronym
Study hypothesis
The main goal of the intervention, in partnership with the Government of India program Integrated Child Development Services (ICDS), is to reduce acute malnutrition for children under three years of age. The study will utilize monitoring and periodic cluster-based to surveys to assess whether there has been a reduction in acute malnutrition in intervention communities for children under the age of three.
Ethics approval
The Bandra Holy Family Medical Research Society, 21/09/2015, ref: ECR/196/INST/MH/2013
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Acute malnutrition
Intervention
The intervention area includes informal settlements in Mumbai covered by the Government of India (GOI) Integrated Child Development Services (ICDS). The NGO, SNEHA will coordinate integration of a Community-based Monitoring of Acute malnutrition (CMAM) approach in conjunction with ongoing ICDS services, focusing on children under the age of three. The additional activities in intervention areas include screening for acute malnutrition, growth monitoring, home-based counselling, medical screenings, vaccination updates, referrals to public health facilities such as a municipal nutrition rehabilitation center. Screening is an ongoing process of case finding and enrollment of all children under three years of age and pregnant women into the CMAM program.
The comparison area is a quasi-control area that has not been randomly allocated. The comparison area will include informal settlements in another part of Mumbai where the NGO does not provide any additional services to community, but ICDS services are being delivered. Participants for the study are selected randomly (cross-sectional cluster-based random samples) from the comparison areas.
Intervention Areas:
Pilot Phase One Areas: (population ~ 90,000) ran a full intervention from February 2012 through February 2014 and a limited intervention from March 2014 to March 2016. Follow up evaluations conducted in February 2014 and October 2015.
Pilot Phase Two Areas: (population ~60,000) ran a full intervention from February 2013 through December 2014 and a limited intervention from January 2015 to March 2016. Follow up evaluations conducted in December 2014 and October 2015.
Scale-Out Phases: (population~150,000). Baseline survey conducted from March-July 2014. Full intervention conducted until November-December 2015. Endline survey conducted November-December 2015. Limited intervention conducted from January-March 2016.
Comparison Areas:
Baseline survey conducted September - November 2014. No additional intervention and endline conducted October-December 2015.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Acute malnutrition:
For full intervention: Monthly growth monitoring of anthropometry will be conducted by intervention staff. Gender, weight in kilograms, and height in centimetres will be collected to measure acute malnutrition status based on WHO 2006 WHZ scores.
For evaluation surveys at baseline, follow-up and endline, anthropometry will be conducted by investigators. Gender, weight in kilograms, and height in centimetres will be collected to measure acute malnutrition status based on WHO 2006 WHZ scores.
Equipment used for both intervention and evaluation anthropometry include: Bubble levels (manufactured by Freemans Measures Pvt. Ltd.) to verify flat weighing locations. Children under two years of age lay or sit on an electronic baby weighing scale (manufactured by Nitiraj Engineers Pvt. Ltd.) and their lengths are measured on an infantometer (manufactured by Meditrin Instruments Pvt. Ltd.). Children over two years of age are weighed on an adult mechanical weighing scale and their heights are taken using carpenter measuring tapes. All measurements are taken by pairs of investigators.
Secondary outcome measures
Uptake of ICDS services by children under the age of three, assessed during the cluster-based cross-sectional evaluation surveys by asking the sampled caregiver whether her youngest child (under age 3) received services from ICDS in the previous month with further probing on what services were received. Measured at baseline, follow-up and endline.
Overall trial start date
01/11/2011
Overall trial end date
31/03/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Boys and girls
2. Under the age of three years
3. Living in the service areas of ICDS
Participant type
All
Age group
Child
Gender
Both
Target number of participants
A minimum of 10,000 children in the study intervention areas. Samples for cluster-based surveys will range from 2000-3500 children sampled per survey.
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/02/2012
Recruitment end date
31/03/2016
Locations
Countries of recruitment
India
Trial participating centre
SNEHA (Society for Nutrition, Education and Health Action)
Behind Building no. 11
BMC Colony
Shastri Nagar
Linking Road Extension
Santa Cruz West
Mumbai
400054
India
Sponsor information
Organisation
Society for Nutrition, Education and Health Action
Sponsor details
Behind Building no. 11
BMC Colony
Shastri Nagar
Linking Road Extension
Mumbai
400054
India
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Forbes Marshall Foundation
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EPIC Foundation
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Breadsticks Foundation
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The Impact Foundation
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Maitri Trust
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HDFC Bank Ltd.
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Comic Relief
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private sector organisation
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other non-profit
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United Kingdom
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Give Foundation
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West Wind School
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Blue Cross Laboratories
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Dimension Data India Ltd.
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Lubrizol Advanced Materials Pvt. Ltd.
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HDB Financial Services Ltd.
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Australian Consulate
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Nihchal Insrani Foundation
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Cipla Foundation
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Care Foundation
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Vishwanath Rao Birewar Foundation Trust
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Jashn Jewels Ltd
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Results and Publications
Publication and dissemination plan
Dissemination of results included a consultation and sharing of results with participation from government and non-government senior officials. This took place on 16/01/017. This is a news article highlighting the event: http://www.asianage.com/metros/mumbai/170117/wasting-in-mumbai-slums-drops-down-to-12-per-cent-survey.html
Further plans include publication in a high-impact peer reviewed journal with intent to publish date by approximately March 2018.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anuja Jayaraman
Intention to publish date
01/03/2018
Participant level data
Available on request
Results - basic reporting
Publication summary