Community-based management of severe acute malnutrition in India: New evidence from Bihar

ISRCTN	ISRCTN13980582
DOI	https://doi.org/10.1186/ISRCTN13980582
Secondary identifying numbers	N/A

Submission date: 22/12/2014
Registration date: 29/01/2015
Last edited: 08/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
According to the third Indian National Family Health Survey-3 (NFHS-3) conducted in 2005-06, 19.8% of children <5 years of age were wasted, while 6.4% suffered from severe acute malnutrition (SAM) in India. While the principal strategy remains inpatient care through Nutritional Rehabilitation Centers and Malnutrition Treatment Centers, there is a growing consensus within India that adoption of Community-Based Management of Acute Malnutrition (CMAM) is crucial to achieving widespread, effective coverage and treatment of all children with SAM.
Following widespread flooding in Bihar, Médecins Sans Frontières (MSF) conducted a household based survey in Darbhanga which found the prevalence of wasting and SAM in children younger than 5 years was 19.4% and 4.8%, respectively. Consequently, under a memorandum of understanding with the district authorities and thereafter with consent from the Bihar State Health Society, in February 2009 MSF initiated a CMAM program in Biraul block, Darbhanga district.
The CMAM model has been extensively used outside India, with over 50 countries adopting this approach as their first-line strategy for treating SAM. CMAM is based on principles that acknowledge both the need for prolonged treatment and the small proportion of children with SAM who require inpatient care for medical reasons, and on evidence that ambulatory management in the community can be a cost-effective solution from both societal and healthcare provider perspectives. A standard CMAM program consists of treatment sites close to the community where the children with ‘uncomplicated’ SAM, who constitute the majority of patients, can be seen weekly, and an inpatient facility (‘Stabilization Center’) that admits only children with SAM plus associated medical complications requiring specialist medical attention, and keeping them only until they recover enough to continue treatment as outpatients in the community.
In this study we look at the routine programme data that has been collected over the life of the programme and present it as an evaluation of the programme as a whole, to see how effective it has been compared to international and national standards. We also present the challenges that the programme faced and possible solutions for policy makers to consider in future decision making.

Who can participate?
Observational study – not applicable

What does the study involve?
Observational study – not applicable

What are the possible benefits and risks of participating?
Observational study – not applicable

Where is the study run from?
Biraul Block, District Dharbhnaga, Bihar, India

When is the study starting and how long is it expected to run for?
Observational study – not applicable
Analysis of data collected from February 2009 to November 2011. Analyse done between January 2014 and March 2014.

Who is funding the study?
Médecins Sans Frontières

Who is the main contact?
Dr Temmy Sunyoto

Contact information

Dr Temmy Sunyoto
Public

C203 Defence Colony
New Delhi
110024
India

Dr Sakib Burza
Scientific

C203 Defence Colony
New Delhi
110024
India

Study information

Study design	Single center observational retrospective cohort study using routinely collected programme data.
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Community
Study type	Prevention
Scientific title	Community-based management of severe acute malnutrition in India: New evidence from Bihar: an observational study
Study objectives	This study is an observational study describing the characteristics and outcomes of 8,274 children with severe acute malnutrition treated by MSF in Dharbhangha district, Bihar, India between February 2009—September 2011 in a routine Community Management of Acute Malnutrition (CMAM) programme. The routinely collected programme data has been retrospectively analysed in this study to provide local policy makers with additional evidence of models of care for severely acute malnutrition in 6 month to 5 year old children.
Ethics approval(s)	This analysis met the Médecins Sans Frontières Institutional Ethics Review Committee criteria for a study involving routinely collected program data. The program utilized a widely recognised treatment model (CMAM) for SAM and was conducted under a memorandum of understanding with the district authorities and thereafter with consent of the Bihar State Health Society, the usual procedure for NGOs operating in this context. All electronic data were analyzed anonymously.
Health condition(s) or problem(s) studied	The condition being studied is Severe Acute Malnitrition (SAM) in children between the ages of 6-59 months.
Intervention	We retrospectively analysed the routinely collected programme data from the CMAM programme, looking at exit outcomes, programme indicators and other challenges facing the implementation of CMAM in this context.
Intervention type	Other
Primary outcome measure	We examined anthropometric and socio-demographic admission and exit characteristics, and classified analysis by discharge as cure, default, death or non-responder.
Secondary outcome measures	We examined risk factors for children defaulting from the programme by analysing anthropometric and socio-demographic criteria at the point of entry to the programme to see if there was any association with risk of defaulting from the programme.
Overall study start date	01/01/2004
Completion date	01/03/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	Not applicable
Key inclusion criteria	All children with severe acute malnutrition presenting and admitted to the CMAM programme between February 2009 and September 2011.
Key exclusion criteria	No exclusion criteria.
Date of first enrolment	01/01/2014
Date of final enrolment	01/03/2014

Locations

Countries of recruitment

India

Study participating centre

Biraul Block, District Dharbhnaga, Bihar

India

Sponsor information

Médecins Sans Frontières
Charity

C203, Defence Colony
New Delhi
110024
India

"ROR"	https://ror.org/032mwd808

Funders

Funder type

Charity

Médecins Sans Frontières

No information available

Results and Publications

Intention to publish date	30/06/2015
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planning to publish in the American Journal of Clinical Nutrition, April 2015. Dissemination will be in India to stakeholders and policy makers in India involved with nutrition.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015		Yes	No