Plain English Summary
Background and study aims:
Urban health is a critical but under-researched requirement for Indias development. The Government of India plans a National Urban Health Mission which recommends decentralization and partnerships between the public, private and non-government sectors. The research programme aims to develop and test a model strategy to improve womens and childrens health in Mumbai slum communities.
Who can participate?
Key participants will be women and their families, but anyone resident in the slum communities involved can participate in activities to improve health.
What does the study involve?
We will set up community resource centres in urban slums. Each centre will be developed in partnership with its surrounding community and health care providers, and staffed by two community mobilizers. With support from a non-government organization hub, they will collect and disseminate health information, identify families at risk, make referrals to appropriate services and follow them up, coordinate community health promotion events, communicate with service providers, and promote interaction between communities and providers.
What are the possible benefits and risks of participating?
Participants will help to improve their own health, the health of their children, and the health of their communities. There are no particular risks to participating.
Where is the study run from?
The study is run by the Society for Nutrition, Education and Health Action, a non-government organization based in Mumbai.
When is the study starting and how long is it expected to run for?
The study will begin in February 2012. 20 community resource centres will be set up in 3 phases over 18 months. Each will run for 2 years, after which outcomes will be compared between the 20 intervention and 20 control areas through a cross-sectional survey. The survey will run from February 2012 to July 2015.
Who is funding the study?
The Wellcome Trust
Who is the main contact?
Dr David Osrin
d.osrin@ucl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Community resource centres to improve the health of women and children in Mumbai slums: a cluster randomized controlled trial of a complex intervention
Acronym
SNEHA CRC
Study hypothesis
Society for Nutrition, Education and Health Action (SNEHA) Community Resource Centre (CRC) Trial.
Community resource centres based in urban slums will improve indicators of maternal health and infant feeding, womens reproductive health, childhood nutrition, and domestic violence
Ethics approval
The Institutional Ethics Committee of the Anusandhan Trust has given the following approvals:
March 2011: Formative research
May 2011: Vulnerability assessment and community guardian study
August 2011: Baseline and endline surveys
November 2011: Community resource centre intervention (approval pending)
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Not available in the web format, please use the contact details to request a patient information sheet
Condition
Womens health, child health, urban health
Intervention
Intervention: 20 slum clusters with community resource centres
Control: 20 slum clusters without community resource centres
In collaboration with communities, we will set up 20 community resource centres, one in each intervention cluster at a dedicated location. Linking with SNEHA expertise across a range of themes, they will:
1. Collect and provide information and education on health issues
2. Identify families at risk and work with them on strategies to improve their health
3. Refer individuals and families to appropriate services
4. Make sure that advice and action is followed up
5. Co-ordinate activities such as home visits, group events and community campaigns
6. Liaise with providers such as ICDS, the Municipal Corporation, local practitioners, police and legal services, and
7. Create opportunities for communities to come together for local action
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Maternity and infant feeding: institutional delivery; exclusive breastfeeding under six months of age
2. Womens reproductive health: use of contemporary family planning methods
3. Childhood nutrition: height-for-age, weight-for-age, weight-for-height
Secondary outcome measures
1. Maternity and infant feeding: uptake of Janani Suraksha Yojana incentive, exclusive breastfeeding in the first month
2. Womens reproductive health: adolescent pregnancies
3. Childhood nutrition: recommended feeding practicies for children 6-23 months of age, weighing of children under 6 years of age at an ICDS centre
4. Domestic violence: consultation with support services in the event of domestic violence
Overall trial start date
01/02/2012
Overall trial end date
31/07/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women aged 15-49 years
2. Who consent to interview and reside in study clusters
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Residents of 20,000 households in 40 urban slum clusters
Participant exclusion criteria
Households used for business purposes, with no female residents
Recruitment start date
01/02/2012
Recruitment end date
31/07/2015
Locations
Countries of recruitment
India
Trial participating centre
UCL Institute of Child Health
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
UCL Centre for International Health and Development (UK)
Sponsor details
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
-
d.osrin@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust ref: 091561/Z/10/Z
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782816
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27020947
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28193399
Publication citations
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Protocol
Shah More N, Das S, Bapat U, Rajguru M, Alcock G, Joshi W, Pantvaidya S, Osrin D, Community resource centres to improve the health of women and children in Mumbai slums: study protocol for a cluster randomized controlled trial., Trials, 2013, 14, 132, doi: 10.1186/1745-6215-14-132.
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Results
S Lignou, S Das, J Mistry, G Alcock, NS More, D Osrin, SJL Edwards, Reconstructing communities in cluster trials?, Trials, 2016, 17, 166, doi: 10.1186/s13063-016-1284-6.