Study of Effect of Microfinance on Under 5 Health in Rural India
A Feasibility and Pilot Study of the Effects of Microfinance on Under 5 Mortality and Nutrition, Amongst the Very Poor in India
1 other identifier
interventional
2,469
1 country
1
Brief Summary
Investigators propose a feasibility and pilot study for a cluster randomised controlled trial. The proposed trial will evaluate the effects of an economic intervention (microfinance) in self-help groups of poor and marginalised women in three provinces in northern India, upon the health of these communities, with a focus on children under five years. This feasibility and pilot study will determine whether accurate data can be collected on mortality by means of a house to house survey or from the register of births and deaths. The feasibility stage will also determine whether village volunteers can accurately weigh children under five and record their weights alongside the financial data already recorded by the self-help group. If these data are accurate and can be collected reliably, the investigators will calculate the power and sample size needed for a future cluster randomised trial, as well as analysing preliminary results from the current project. The investigators will evaluate health outcomes, relating to two Millennium Development Goals: number of children under five years of age who are underweight and the under five mortality rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFebruary 13, 2017
February 1, 2017
2.6 years
April 24, 2013
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight for height z-score of children under five years of age
mean weight for height z-score (WHZ) of children under five years of age in the paired early and late intervention tolas at 18 months after the scheme has been implemented in the early intervention tolas
18 months
Secondary Outcomes (8)
mean weight for age z-score
18 months
mean height for age z-score
18 months
prevalance of moderate to server undernutrition (WAZ < -2SD)
18 months
prevalance of moderate to servere stunting (HAZ < -2SD)
18 months
prevalance of moderate to servere wasting (WHZ< -2SD)
18 months
- +3 more secondary outcomes
Study Arms (2)
Late intervention
NO INTERVENTIONCPSL will support the establishment of self-help groups after 18 months of start of the study.
Early intervention
EXPERIMENTALCPSL will support the establishment of Women's self-help group. Microfinance will be provided to this group from the first 18 months of the study. The women in these groups will be eligible for emergency loans (up to Rs3000) and general purpose loans, (Rs50-3000) after 3-6 months of starting the self-help groups.
Interventions
The CPSL staff will support the formation of the self-help groups from the start of the study. The women in this group will have access to microfinance from the first 18 months of the study and will be eligible for emergency loans (up to Rs3000) and general purpose loans, (Rs50-3000) after 3-6 months of starting the self-help group.
Eligibility Criteria
You may qualify if:
- Women in tolas who give informed consent for participation in the study
- Under five children of women who consent for participation
You may not qualify if:
- Women who refuse consent
- Children of women who refuse consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Patna Medical College Hospital
Patna, Bihar, 800004, India
Related Publications (2)
Ojha S, Szatkowski L, Sinha R, Yaron G, Fogarty A, Allen S, Choudhary S, Smyth AR. Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial. Trials. 2014 Jul 23;15:298. doi: 10.1186/1745-6215-15-298.
PMID: 25052420BACKGROUNDOjha S, Szatkowski L, Sinha R, Yaron G, Fogarty A, Allen SJ, Choudhary S, Smyth AR. Rojiroti microfinance and child nutrition: a cluster randomised trial. Arch Dis Child. 2020 Mar;105(3):229-235. doi: 10.1136/archdischild-2018-316471. Epub 2019 Oct 10.
PMID: 31601571DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Smyth
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
May 3, 2013
Study Start
August 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
February 13, 2017
Record last verified: 2017-02