Study of Effect of Microfinance on Under 5 Health in Rural India
Condition: Underweight; Malnutrition
MeSH terms: Malnutrition; Thinness
Study type: Interventional

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.
    

Detailed description: 
      Background Microfinance is a process whereby small loans are given to the poorest families in
      developing countries to help overcome short term economic shocks (natural disasters or ill
      health) or to make small investments to improve their standard of living (eg in livestock.
      Microfinance has been shown to contribute to reducing poverty (particularly of female
      participants) and to improve the health of village economies. The Rojiroti scheme of
      microfinance has been running in several impoverished states in Northern India for ten years.
      This low cost scheme has been active in the states of Bihar, Madhya Pradesh and Uttar Pradesh
      and serves much poorer beneficiaries than those reached by mainstream microfinance. It works
      through establishing self-help groups (predominantly women from scheduled castes). Initially
      the members of these groups contribute their own money - a very small sum per week. After 3-6
      months they become eligible for emergency loans for medical emergencies and general purpose
      loans, for investment in livestock etc.. These loans are administered locally by the charity
      "Centre for Promoting Sustainable Livelihoods" (CPSL). Rojiroti UK have just received a grant
      from the Department for International Development (DfID) for a 3 year expansion of the
      Rojiroti programme. Most of the participants in the Rojiroti scheme live in rural hamlets or
      "tolas", comprising several hundred people who earn a living by share cropping, as tenant
      farmers.

      The investigators will evaluate the feasibility of collecting mortality data (both directly
      in the tola and through registered deaths) and the feasibility of a village volunteer
      weighing children under five and recording their weights, along with other self-help group
      data. If data collection proves feasible, the investigators will conduct a pilot cluster
      randomised trial of immediate vs. delayed microfinance in 50 tolas in Bihar. Trial outcomes
      will be mortality and weight for age Z score, weight for height z-scores and mid upper arm
      circumference in children less than 5 years of age.

      Main centres Rojiroti is already established in northern Indian provinces of Bihar, Madhya
      Pradesh and Uttar Pradesh. In this study, the investigators plan to enrol tolas from Bihar.
      In the feasibility study there will be 10 tolas in each arm. If the data reach acceptable
      standards of accuracy and completeness, the investigators will continue the study in a
      further 40 tolas in each arm (total 50 tolas per arm, 100 altogether). The data analysis will
      be undertaken in the School of Medicine, University of Nottingham.

      Design A feasibility and pilot study for a cluster randomised controlled trial (RCT). The
      unit of randomisation is the tola. A control tola, paired with each intervention tola, will
      be randomly selected to have similar characteristics (size and agroeconomic zone) to the
      early intervention tola. The control tola will be at least 15km away from the intervention
      site (to avoid self-help groups being set up by word of mouth) but close enough to be
      practical for data collection. The control tola will receive the microfinance intervention 18
      months after randomisation.

      Selection and randomisation of intervention sites The investigators will select tolas in
      Bihar province for the feasibility study (10 intervention and 10 control). It is important to
      include the control tolas at the feasibility stage, as the investigators think the challenges
      to complete and accurate data collection will be greater in the control tolas. Pairs of tolas
      will be selected by CPSL and the details provided to the team at the University of Nottingham
      in a secure, password protected spreadsheet, with each tola identified by a code number. The
      Nottingham team will randomise one of each pair to intervention or control group.
      Randomisation will be stratified by agroeconomic region (low, moderate and heavy annual
      rainfall).

      Consent and randomisation Initial discussions will take place between CPSL staff and women in
      the tolas prior to randomisation. The project will only proceed in that tola if sufficient
      village women (around 10) have expressed an interest in participating in self-help groups.
      The idea of the immediate and delayed intervention groups will be discussed with the women,
      by the CPSL staff. Women will have the option to agree to go ahead with the self-help groups,
      with or without randomisation and collection of health outcome data. The investigators will
      keep a record of the demographic characteristics of any tola which does not take part as well
      as those which do.

      Tolas agree to participate before they are randomised to immediate or delayed intervention
      groups. Randomisation will take place remotely and tolas are then informed through CPSL to
      which study arm they have been randomised.

      Evaluating the accuracy and completeness of data collection

      More than one self-help group may be set up in each tola but outcome data will be collected
      for the tola as a whole, in order to measure the effects of the intervention on those
      families in the self-help group and any the indirect effects on tola dwellers who are not
      part of the groups. Accuracy of data collection and recording will be evaluated through a
      field visit by CPSL staff. At this baseline visit, the CPSL staff and the village volunteer
      will independently:

        -  Estimate, using a questionnaire, the total population (and population under 5 years) of
           the tola and the number of deaths in the last year (and deaths in children under 5
           years).

        -  Record the weight, height and mid upper arm circumference and age of each child under 5,
           using scales and measures provided by CPSL.

      These data will then be entered in a spreadsheet by CPSL staff and transferred to the team in
      Nottingham who will calculate the percentage concordance. Concordance of 75% or greater
      between the records of the CPSL worker and the village volunteer for population and mortality
      data will be deemed of acceptable accuracy. Concordance of the under five weights (to one
      decimal place) for 75% of children will be taken as acceptable. As well as checking the
      accuracy of weighing and weight recording, the CPSL staff will determine the number of
      children under five have not been weighed (e.g. children who are temporarily absent from the
      village and those who are ill). Data will also be collected on immunisation rates. The
      investigators will apply for access to data on registered deaths in each tola, from the
      provincial government and the investigators will use these to check the validity of the
      mortality data obtained from questionnaires.

      Statistical analysis plan Sample size and power calculations: This will be performed to
      inform a future RCT, using the data collected as part of the current study. If there are
      sufficient, reliable data available at the end of the feasibility stage, a preliminary power
      calculation will be performed to determine whether the pilot study might detect a clinically
      important difference in mortality, proportion underweight or weight for age z score. If so,
      the trial will move from pilot status to definitive trial. Published estimates of nutrition
      in Bihar date back to 2006 and suggest that 55% of under fives in Bihar are underweight (61%
      amongst children from scheduled castes). This may well have changed considerably in the last
      6 years. This pilot study will provide a current estimate of the baseline prevalence of
      mortality and underweight. The sample size calculation for cluster randomised trials
      described by Hayes et al will be used.

      Type of analysis: In the pilot study and any future trial, intention to treat analysis will
      be used where possible i.e. where a tola has been randomised to receive microfinance early or
      late, their data will be included irrespective of whether the self-help group and
      microfinance have run successfully.

      Statistics tests: We will compare the proportion of children who are underweight and the
      mortality rate in the last year (deaths in the past year / population of the tola) in
      intervention and control tolas. This will be done at baseline and 18 months after the
      establishment of a self-help group in the early intervention tola. In order to estimate
      current tola population, the investigator will use a questionnaire administered by the CPSL
      worker when the children are weighed. An adjusted risk ratio (RR) with 95% confidence
      interval will be calculated, allowing for potential confounding effects of the
      pre-intervention prevalence of underweight or the mortality rate. As this is a cluster
      randomised trial based in small population units (tolas), the investigators will allow for
      correlation within zones.

      Planned exploratory analyses: The investigators will explore whether data can be collected on
      maternal literacy and years of schooling received. If the data are available, the
      investigators will compare the effectiveness of the intervention according to whether the
      mother was literate or illiterate and whether or not she had received at least 5 years of
      schooling.

      Change in primary outcome: In the initial study protocol, the primary outcome measures were
      mortality rate among children under five years of age and the overall mortaility in the tola.
      However, on further consideratation, this was changed to mean weight for height z-score (WHZ)
      if children under five years of age. Given the short duration of the study period (18
      months), it was thought that any effect of the intervention on mortaility rates may not be
      evident in the study period. WHZ is a marker of acute malnutrion and wasting and Children
      with severe wasting (WHZ < -3 SD) have a 9.4-fold higher chance of dying while those with
      moderate wasting (WHZ -3 to -2 SD) have a 3.0-fold higher chance of dying when compared with
      their nonmalnourished counterparts. WHZ was therefore selected to be the primary outcome
      measure as it is strongly associated with mortality and may be affected by the intervention
      within the short duration of the study period.

      This change in protocol was made prior to randomisation and baseline data collection and is
      reported in the protocol publication.
    

Intervention name(s): Early provision of microfinance
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: microfinance; under five mortality; underweight; malnutrition