FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2012/09/003004 [Registered on: 18/09/2012] Trial Registered Retrospectively
Last Modified On: 28/08/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Community mobilization]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Trial of community resource centres to improve women?s and children?s health in Mumbai slums 
Scientific Title of Study   Community resource centres to improve the health of women and children in Mumbai informal settlements: a cluster randomized controlled trial of a complex intervention 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr David Osrin 
Designation  Wellcome Trust Senior Research Fellow in Clinical Science 
Affiliation  University College London 
Address  Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Shahunagar, Dharavi

Mumbai
MAHARASHTRA
400017
India 
Phone  02224042627  
Fax    
Email  d.osrin@ucl.ac.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr David Osrin 
Designation  Wellcome Trust Senior Research Fellow in Clinical Science 
Affiliation  University College London 
Address  Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Shahunagar, Dharavi

Mumbai
MAHARASHTRA
400017
India 
Phone  02224042627  
Fax    
Email  d.osrin@ucl.ac.uk  
 
Details of Contact Person
Public Query
 
Name  Neena Shah More 
Designation  Project Director 
Affiliation  SNEHA 
Address  Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Shahunagar, Dharavi

Mumbai
MAHARASHTRA
400017
India 
Phone  02224042627  
Fax    
Email  neena@snehamumbai.org  
 
Source of Monetary or Material Support  
The Wellcome Trust UK 
 
Primary Sponsor  
Name  Centre for International Health and Developoment 
Address  UCL Institute of Child Health, 30 Guilford Street, London WC1N 1EH, UK 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Dr Wasundhara Joshi  Urban Health Centre, 60 Feet Road, Shahunagar, Dharavi, Mumbai 400017, Maharashtra 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neena Shah More  Society for Nutrition, Education and Health Action (SNEHA)  Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre ,60 Feet Road, Shahunagar, Dharavi-400017
Mumbai
MAHARASHTRA 
02224042627

neena@snehamumbai.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Multi-institutional Ethics Committee of the Anusandhan Trust  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No specific health condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention: Community Resource centres will be set up in each of the 20 Intervention clusters. 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  The centres will: Act as bases for collection and dissemination of health in-formation. Identify families at risk and refer individuals and families to appropriate services. Coordinate health promotion events. Communicate and negotiate with health care providers. Broker interaction between communities and providers for universal health coverage. Public sector health service strengthening will be actively undertaken in intervention clusters. Information on ongoing activities will be disseminated through a Community Action Group. 
Comparator Agent  Public sector health service strengthening   Ongoing activities to improve quality of care, in partnership with the Municipal Corporation of Greater Mumbai 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  We will select two of Mumbai’s 24 municipal wards based on low Human Development Indices.
We will identify the informal settlement areas in the chosen wards, both formally recognized and unrecognized.
The minimum cluster size for inclusion will be 1000 house-holds. Where informal settlements are large we will divide them into smaller clusters along obvious geophysical bounda-ries: one large area may then provide more than one poten-tial trial cluster. We will try to avoid contiguity to minimize contamination.
Using a tool for the rapid assessment of health vulnerability, each potential informal settlement cluster will be given a score. The 40 highest scoring clusters will constitute the trial frame. 20 will be allocated randomly to the intervention. 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Institutional delivery (%)
Infant feeding
Family planning (%)
Child stunting and weight-for-height 
Intervention and control arms compared after 2 years of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Consultation for domestic violence  Number of consultations for domestic violence in intervention areas tracked over 2 years. 
 
Target Sample Size   Total Sample Size="20000"
Sample Size from India="20000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary   1. Background and study aims
Urban health is a critical but under-researched requirement for India’s development. The research programme aims to develop and test a model strategy to improve women’s and children’s health in Mumbai slum communities.
2. 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.

3. 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.
4. 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.
Participants may become involved in the trial in two ways. First, in intervention areas, they may join in community efforts to improve women’s and children’s health in association with the resource centres. They may gain information about these efforts through community discussions, campaigns, outreach activities, or by visiting the resource centre. Second, they may participate in the evaluation by responding to a questionnaire interview in the baseline or endline phase. Information on the trial will be communicated orally by interviewers prior to consent, and potential participants will be given printed study information material in a local language. Participants will not be followed up individually over the course of the trial evaluation, since it will be based on a cross-sectional endline survey. Other information about the progress of the community resource centres will be disseminated through Community Action Groups, as and when they feel it would be appropriate.
5. 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.
6. 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 to July 2015.
7. How will information on the study be disseminated?
A Community Action Group will be associated with each resource centre, and will communicate study progress locally. The findings will be published in open access peer-reviewed journals.
 
Close