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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 October 2019 |
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Main ID: |
ISRCTN62834195 |
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Date of registration:
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16/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a community-based management of acute malnutrition program in urban informal settlements, Mumbai
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Scientific title:
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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? |
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Date of first enrolment:
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01/02/2012 |
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Target sample size:
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10000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN62834195 |
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Study type:
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Interventional |
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Study design:
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Interventional non-randomised study (Other)
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Phase:
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Not Applicable
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Countries of recruitment
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India
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Contacts
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Name:
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Anuja
Jayaraman |
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Address:
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Behind Building no. 11
BMC Colony
Shastri Nagar
Linking Road Extension
Santa Cruz West
400054
Mumbai
India |
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Email:
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Boys and girls
2. Under the age of three years
3. Living in the service areas of ICDS
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute malnutrition
Nutritional, Metabolic, Endocrine
Malnutrition
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Forbes Marshall Foundation, EPIC Foundation, Breadsticks Foundation, The Impact Foundation, Maitri Trust, HDFC Bank Ltd., Comic Relief, Give Foundation, West Wind School, Blue Cross Laboratories, Dimension Data India Ltd., Lubrizol Advanced Materials Pvt. Ltd., HDB Financial Services Ltd., Australian Consulate , Nihchal Insrani Foundation, Cipla Foundation, Care Foundation, Vishwanath Rao Birewar Foundation Trust, Jashn Jewels Ltd
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Ethics review
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Status:
Approval date:
Contact:
The Bandra Holy Family Medical Research Society, 21/09/2015, ref: ECR/196/INST/MH/2013
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2017 |
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URL:
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