| 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 |
|
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Source of Monetary or Material Support
|
|
|
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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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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. |
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Outcome Assessor Blinded |
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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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Consultation for domestic violence |
Number of consultations for domestic violence in intervention areas tracked over 2 years. |
|
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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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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.
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