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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845545
First Posted: May 3, 2013
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Nottingham
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Feasibility and Pilot Study of the Effects of Microfinance on Under 5 Mortality and Nutrition, Amongst the Very Poor in India

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Weight for height z-score of children under five years of age [ Time Frame: 18 months ]
    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


Secondary Outcome Measures:
  • mean weight for age z-score [ Time Frame: 18 months ]
    mean weight for age z-score (WAZ) 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

  • mean height for age z-score [ Time Frame: 18 months ]
    mean height for age z-score (HAZ) 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

  • prevalance of moderate to server undernutrition (WAZ < -2SD) [ Time Frame: 18 months ]
    prevalance of moderate to server undernutrition (WAZ < -2SD) among 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

  • prevalance of moderate to servere stunting (HAZ < -2SD) [ Time Frame: 18 months ]
    prevalance of moderate to server stunting (HAZ < -2SD) among 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

  • prevalance of moderate to servere wasting (WHZ< -2SD) [ Time Frame: 18 months ]
    prevalance of moderate to server wasting (WHZ< -2SD) among 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

  • Mid upper arm circumference [ Time Frame: baseline and 18 months ]
    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

  • prevalence of moderate to acute malnutrition (based on MUAC 12.5 to 11.5cm) [ Time Frame: 8 months ]
    prevalence of moderate to severe acute malnutrition (based on MUAC between 12.5 and 11.5 cm and MUAC <11.5 cm, respectively) in children between 6 and 60 months of age in the early versus late intervention tolas 18 months from the start of the study

  • prevalence of severe malnutrition (based on MUAC <11.5) [ Time Frame: 18 months ]
    prevalence of severe acute malnutrition (based on MUAC < 11.5) in children between 6 and 60 months of age in the early versus late intervention tolas 18 months from the start of the study


Enrollment: 2469
Study Start Date: August 2013
Study Completion Date: March 2016
Primary Completion Date: March 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845545


Locations
India
Patna Medical College Hospital
Patna, Bihar, India, 800004
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Alan Smyth University of Nottingham
  More Information

Additional Information:
Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01845545     History of Changes
Other Study ID Numbers: UoN-J18102012
First Submitted: April 24, 2013
First Posted: May 3, 2013
Last Update Posted: February 13, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Malnutrition
Thinness
Nutrition Disorders
Body Weight
Signs and Symptoms