Condition category
Not Applicable
Date applied
09/11/2011
Date assigned
14/11/2011
Last edited
29/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Urban health is a critical but under-researched requirement for India’s 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 women’s and children’s 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

Contact information

Type

Scientific

Primary contact

Dr David Osrin

ORCID ID

Contact details

Centre for International Health and Development
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

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 Trial

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, women’s 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 below to request a patient information sheet

Condition

Women’s 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. Women’s 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. Women’s 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

http://www.ucl.ac.uk/cihd

Funders

Funder type

Charity

Funder name

Wellcome Trust ref: 091561/Z/10/Z

Alternative name(s)

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://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1284-6

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

29/03/2016: Publication reference added.