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Infant Health and Child Thriving: A Cohort Study in Tamil Nadu
Last registered on October 17, 2019

Pre-Trial

Trial Information
General Information
Title
Infant Health and Child Thriving: A Cohort Study in Tamil Nadu
RCT ID
AEARCTR-0001095
Initial registration date
August 04, 2016
Last updated
October 17, 2019 1:06 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
Dartmouth College
Other Primary Investigator(s)
PI Affiliation
American Univeristy
Additional Trial Information
Status
Withdrawn
Start date
2017-10-01
End date
2019-10-31
Secondary IDs
Abstract
Tamil Nadu is a nation-wide leader in child health. However, poor nutritional outcomes for infants and children remain a serious challenge. For example, according to National Family Health Survey 4 (2015-16), only 48.3% of children under 6 months of age are exclusively breastfed. About 50.7% of children aged 6-59 months are anaemic. Rates of full immunization has dropped from 80.9% in 2005-06 to 69.7% in 2014-15. In order to continue advancement in child health outcomes, the state needs evidence on what policies and programs are most effective in child thriving. Evidence also suggests that infant’s health is determined before a child is born and maternal health and nutrition are associated with child health outcomes.
Hence, J-PAL SA has proposed to lay the groundwork for a cohort study of infants in Tamil Nadu. This cohort study will begin by interviewing pregnant mothers and their mothers/mothers-in-law in the ante-natal period and continue to track the infants through the post-natal period. The study will help analyse how maternal health and nutrition, family dynamics and household decision- making influence infant health and later child health outcomes.
During this cohort study, a randomized evaluation will be conducted to test the effectiveness of enhanced breastfeeding education of mothers and grandmothers on exclusive breastfeeding outcomes. As part of this evaluation, health workers in sample districts will be trained on an enhanced breastfeeding curriculum based on which they will conduct family based sessions with mothers and grandmothers in the villages.
External Link(s)
Registration Citation
Citation
Leight, Jessica and Simone Schaner. 2019. "Infant Health and Child Thriving: A Cohort Study in Tamil Nadu." AEA RCT Registry. October 17. https://doi.org/10.1257/rct.1095-3.0.
Former Citation
Leight, Jessica, Simone Schaner and Simone Schaner. 2019. "Infant Health and Child Thriving: A Cohort Study in Tamil Nadu." AEA RCT Registry. October 17. https://www.socialscienceregistry.org/trials/1095/history/55333.
Experimental Details
Interventions
Intervention(s)
We will define the cohort by conducting a census of pregnant women living in the catchment areas of 309 subcentres in Tamil Nadu. We will then randomly select 25 women per subcentre for inclusion in the study. 2 The first round of the cohort study (the pre-birth “baseline”) will be conducted in two waves over a 4-month period. We will also survey the mother or mother-in-law of each sampled woman in order to paint a rich picture of household dynamics and decision-making, health practices, and beliefs before children are born; in households where the mother has other children, we will collect detailed information about their health and nutritional status. In addition, we will collect data on the pregnant mother’s upper arm circumference as a measure of her prenatal health. (The division of the grandmother sample between the mothers and mothers-in-law of sampled women will be determined in the initial study design phase based on information about the expected proximity of households to the natal families of both the husband and wife.)
Immediately following the conclusion of the baseline survey, we will conduct the first randomized controlled trial, which will focus on exclusive breastfeeding (see the next section for more detail).
The research team will then conduct a second wave of data collection from the full cohort of mothers and infants approximately eight months after the baseline, when most sampled children are between the ages of 16 months. This wave will collect data on beliefs about breastfeeding, self-reported measures of breastfeeding, and household decision-making power (especially vis-à-vis mothers-in-law). Data will also be collected on infant health, including reported diarrheal episodes, respiratory illness episodes, and anthropometric data on weight and height; this data will allow us to measure stunting and wasting. We will also track any infant deaths, though the sample size suggests that these will be limited in number, and re-survey the sample of grandmothers to understand whether their knowledge and attitudes around infant feeding practices and infant health change following the birth of a grandchild, and to evaluate whether intrahousehold decision-making has changed in the postnatal period. For any infant deaths observed, we will conduct a verbal autopsy with the household to attempt to ascertain cause of death. Finally, we will collect data on services delivered and hours worked by the VHN and anganwadi workers.
Although this proposal only covers the first two waves of data collection, the long-run objective of this project is to continue following the cohort of children as they age. For this reason, we will also collect identifying information for the households that will allow us to track the infants in the future. This will include Aadhaar numbers, if available; birth registration identifiers; and full contact information for the family.

First Randomized Controlled Trial

The first randomized controlled trial falling under the umbrella of this project will focus on improving health during the first six months of life by promoting exclusive breastfeeding. Since new mothers often turn to their own mothers and mothers-in-law for advice on infant care, we believe a two-pronged approach to changing breastfeeding behavior and enhancing infant health could be especially effective:
 First, address information gaps among mothers themselves. Here, we build upon existing research demonstrating that behavioural change counseling delivered via community-based health workers or women’s groups can increase breastfeeding rates and improve child health (Bhandari et al. 2003, Tripathy et al. 2010). An important limitation of these studies, however, is that they both examined intensive, multi-faceted interventions. A guiding principle of our project is that the interventions evaluated should be simple and scalable from the perspective of the Government of Tamil Nadu (GoTN).  Second, engage grandmothers in supporting their daughters and daughters-in-law to exclusively breastfeed. Again, we believe that scalability is key in order to minimize the cost of including grandmothers in breastfeeding education. Accordingly, we are interested in evaluating the effectiveness of including both mothers and grandmothers in behavioural change sessions conducted by VHNs and anganwadi workers.

Together with the Government of Tamil Nadu, we have already pilot-tested a behavioral-change curriculum that follows the principles above (see the appendix for more details on the pilot). The proposed full-scale experiment is designed to answer the following key policy questions:
1. Can improved breastfeeding counseling increase rates of exclusive breastfeeding among new mothers, and does engaging grandmothers in the education process increase adherence to exclusive breastfeeding? 2. Do the two enhanced education policies (mothers alone, mothers and grandmothers) lead to measurable health benefits for young children: particularly, a reduction in the incidence of illnesses in infancy, and increases in height-for-age and weight-for-age? 3. From the perspective of GoTN, which policy is the most cost-effective way of improving breastfeeding behavior and infant health?
Accordingly, we seek to evaluate two versions of our enhanced exclusive breastfeeding education program. The interventions will follow the same structure and use the same materials as employed in the pilot, with minor modifications. In the first treatment arm, breastfeeding education will only target mothers; in the second treatment arm, both mothers and grandmothers will be targeted. In both arms, the primary objectives of the enhanced breastfeeding curriculum can be described as follows.
1. Close knowledge gaps among women: The educational sessions are designed to target major information gaps we identified among mothers and grandmothers during the pilot. The sessions will emphasize the benefits of exclusive breastfeeding and aid mothers and their families in addressing the common dilemmas faced by expectant and new mothers. Given that mothers may not have previously had access to such a forum, the opportunity to discuss challenges in infant health may have a positive impact on infant thriving.
2. Reinforce key messages with visual aids: Health workers will utilize a series of four posters specifically designed to support the group sessions. These posters, designed with behavioural change strategies in mind, convey the main messages around exclusive breastfeeding and reinforce the enhanced curriculum. The posters are meant to be used during the group sessions and to be displayed at the angwanwadi center at all times to provide women with ongoing reminders to exclusively breastfeed. 3. Provide specialised training for health workers: VHNs and anganwadi workers will attend a 3 day training session (developed during the pilot) specially designed to prepare them to conduct the group meetings. The training will include a refresher on the primary GoTN breastfeeding guidelines, along with extensive instruction on behavioural change communication and how to conduct a group session, as well as supervised practice.
Our calculations suggest that in order to attain sufficient statistical power, a full-scale evaluation would need to be implemented in 300 sub-centres in Tamil Nadu – thus, the cohort study can comfortably accommodate this evaluation. The sub-centres enrolled in the evaluation (and affiliated VHNs and anganwadi workers) would be randomly assigned to one of three evaluation arms:
1. Status quo policies (control arm) – VHNs and anganwadi workers in these sub-centres would receive no new training and conduct their duties as usual throughout the study period. 2. Enhanced education for mothers – VHNs and anganwadi workers in these sub-centres would be trained on the enhanced breastfeeding curriculum and would be instructed to administer the curriculum in regular group meetings in all villages falling under their purview. These health workers would not be instructed to include grandmothers in the process. 3. Enhanced education for mothers and grandmothers – VHNs and anganwadi workers in these sub-centres would be trained on the enhanced breastfeeding curriculum and would be instructed to administer the curriculum to both mothers and grandmothers. The treatment arms will be slightly larger than the control arm (38% of sub-centres will be assigned to each treatment arm, and the remaining 24% to the control arm) in order to give us more statistical power to detect differences between the “mothers only” and “mothers plus grandmothers” interventions. VHNs and anganwadi workers in treatment arms will be trained on the new curriculum. Given the large number of health workers included, we anticipate training health workers in multiple batches over four weeks; each individual training session will include no more than 30 individuals. Following the conclusion of the training, health workers will begin to conduct weekly family-based behavioural change sessions in the villages they serve. The research team will conduct random spot-checks to monitor the implementation of the intervention, assessing whether a given meeting took place and evaluating the quality of the meeting using instruments developed as part of the pilot.
Intervention Start Date
2018-04-01
Intervention End Date
2018-12-31
Primary Outcomes
Primary Outcomes (end points)
Beliefs about breastfeeding, self-reported measures of breastfeeding, infant health measured by reported diarrheal episodes, respiratory episodes and anthropometric data on weight and height, and knowledge and attitudes of grandmothers on infant feeding practices.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The proposed full-scale experiment is designed to answer the following key policy questions:
1. Can improved breastfeeding counseling increase rates of exclusive breastfeeding among new mothers?
2. Does engaging grandmothers in the education process increase adherence to exclusive breastfeeding guidelines?
3. Do the two enhanced education policies (mothers alone, mothers and grandmothers) lead to measurable health benefits for young children?
4. From the perspective of GoTN, which policy is the most cost-effective way of improving breastfeeding behavior and infant health?
Accordingly, we seek to evaluate two versions of our enhanced exclusive breastfeeding education program. In both arms, the primary objectives of the enhanced breastfeeding curriculum can be described as follows.
1. Close knowledge gaps among women: The educational sessions are designed to target major information gaps we identified among mothers and grandmothers during the pilot. The sessions will emphasize the benefits of exclusive breastfeeding and aid mothers and their families in addressing the common dilemmas faced by expectant and new mothers. The group meeting is designed to be a forum for mothers (and, when relevant, grandmothers) to openly discuss breastfeeding and related challenges in infant feeding and infant health.
2. Reinforce key messages with visual aids: Health workers will utilize a series of four posters specifically designed to support the group sessions. These posters, designed with behavioural change strategies in mind, convey the main messages around exclusive breastfeeding and reinforce the enhanced curriculum. The posters are meant to be used during the group sessions and to be displayed at the angwanwadi center at all times to provide women with ongoing reminders to exclusively breastfeed.
3. Provide specialised training for health workers: VHNs and anganwadi workers will attend a 3 day training session (developed during the pilot) specially designed to prepare them to conduct the group meetings. The training will include a refresher on the primary GoTN breastfeeding guidelines, along with extensive instruction on behavioural change communication and how to conduct a group session, as well as supervised practice. The training will be expanded relative to the training provided in the pilot to address the challenges previously identified, and particularly to provide more opportunities for active practice.
Our calculations suggest that in order to attain sufficient statistical power, a full-scale evaluation would need to be implemented in 300 sub-centres in Tamil Nadu. We will jointly select 1-2 districts for the evaluation in conjunction with the Health Department, with the objective of choosing districts that are representative of the state, as well as districts where the posters developed during the pilot have not been previously disseminated. The sub-centres enrolled in the evaluation (and affiliated VHNs and anganwadi workers) would be randomly assigned to one of three evaluation arms:
1. Status quo policies (control arm) – VHNs and anganwadi workers in these sub-centres would receive no new training and conduct their duties as usual throughout the study period.
2. Enhanced education for mothers – VHNs and anganwadi workers in these sub-centres would be trained on the enhanced breastfeeding curriculum and would be instructed to administer the curriculum in regular group meetings in all villages falling under their purview. These health workers would not be instructed to include grandmothers in the process.
3. Enhanced education for mothers and grandmothers – VHNs and anganwadi workers in these sub-centres would be trained on the enhanced breastfeeding curriculum and would be instructed to administer the curriculum to both mothers and grandmothers.

The treatment arms will be slightly larger than the control arm (38% of sub-centres will be assigned to each treatment arm, and the remaining 24% to the control arm) in order to give us more statistical power to detect differences between the “mothers only” and “mothers plus grandmothers”interventions.
Experimental Design Details
Randomization Method
The randomization will be done on a computer, using Stata.
Randomization Unit
Health sub-centres, which are the peripheral outpost of health structure in India. A health sub-centre caters to a population of 3000 to 5000 people and is the first point of contact in the health system.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
309 sub centres
Sample size: planned number of observations
25 women per sub centre
Sample size (or number of clusters) by treatment arms
75 centres in control arm, 117 centres in first treatment arm and 117 centres in second treatment arm.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Dartmouth College
IRB Approval Date
2016-04-28
IRB Approval Number
00028433
IRB Name
IFMR
IRB Approval Date
2016-04-16
IRB Approval Number
N/A
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers