Study of Effect of Microfinance on Under 5 Health in Rural India

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01845545
First received: April 24, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Underweight
Malnutrition
Other: Early provision of microfinance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: A Feasibility and Pilot Study of the Effects of Microfinance on Under 5 Mortality and Nutrition, Amongst the Very Poor in India

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Under five mortality rate [ Time Frame: baseline and 18 months ] [ Designated as safety issue: Yes ]
    Under five mortality in the paired early and late intervention tolas will be compared 18 months after the self-help groups are established in the early intervention tolas.

  • Overall mortality rate [ Time Frame: baseline and 18 months ] [ Designated as safety issue: Yes ]
    The overall mortality in the paired early and late intervention tolas will be compared 18 months after the self-help groups are established in the early intervention tolas.


Secondary Outcome Measures:
  • Prevalence of under weight (z score less than -2) in children under five years [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]
    Prevalence of under weight (z score less than -2) in children under five years in the paired early vs. late intervention tolas will be compared at 18 months i.e. before the late intervention group have received microfinance.

  • change in weight for age Z score [ Time Frame: baseline and 18 months ] [ Designated as safety issue: No ]
    Change in weight for age Z score in children under five years in the paired early vs. late intervention tolas will be compared at 18 months i.e. before the late intervention group have received microfinance.

  • Weight for height z-score [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Weight for height z-score in children under 5 years of age in the paired early vs. late intervention tolas will be compared at 18 months

  • Mid upper arm circumference [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Mid upper arm circumference (MUAC) in children less than 5 years of age in paired early vs. late intervention tolas will be compared at 18 months


Estimated Enrollment: 800
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Late intervention
CPSL will support the establishment of self-help groups after 18 months of start of the study.
Experimental: Early intervention
CPSL 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.
Other: Early provision of microfinance
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women in tolas who give informed consent for participation in the study
  • Under five children of women who consent for participation

Exclusion Criteria:

  • Women who refuse consent
  • Children of women who refuse consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845545

Contacts
Contact: Shalini Ojha, MBBS MRCPCH 0044 115 8230619 Shalini.Ojha@nottingham.ac.uk
Contact: Alan Smyth Alan.Smyth@nottingham.ac.uk

Locations
India
Patna Medical College Hospital Recruiting
Patna, Bihar, India, 800004
Contact: Ranjeet Sinha       dr.ranjeetsinha@gmail.com   
Principal Investigator: Ranjeet Sinha         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Alan Smyth University of Nottingham
  More Information

No publications provided by University of Nottingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01845545     History of Changes
Other Study ID Numbers: UoN-J18102012
Study First Received: April 24, 2013
Last Updated: October 8, 2013
Health Authority: United Kingdom: University of Nottingham

Keywords provided by University of Nottingham:
microfinance
under five mortality
underweight
malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 30, 2014