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Infant Health and Child Thriving: A Cohort Study in Tamil Nadu

Last registered on August 04, 2016

Pre-Trial

Trial Information

General Information

Title
Engaging women to improve breastfeeding outcomes in Tamil Nadu
RCT ID
AEARCTR-0001095
Initial registration date
August 04, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
August 04, 2016, 3:00 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
University of Southern California

Other Primary Investigator(s)

PI Affiliation
Williams College

Additional Trial Information

Status
In development
Start date
2016-06-01
End date
2017-12-31
Secondary IDs
Abstract
Although Tamil Nadu is an India-wide leader in child health, many Tamil mothers fail to exclusively breastfeed their children for the recommended first six months of life. One issue here may be that mothers have incomplete information about the benefits of exclusive breastfeeding. Yet even if mothers themselves have complete information, they may not be able to adhere to exclusive breastfeeding guidelines if other (less well informed) household members pressure mothers to give children other types of food. We will conduct a randomized controlled trial to evaluate the effectiveness of to alternative interventions to shed light on the importance of intra-household information asymmetries, to be implemented between June 2016 and October 2017. This randomized controlled trial will include 309 health centers and a sample of 7,725 mothers and infants, randomly assigned to three arms: a control arm, a treatment arm in which a breastfeeding information curriculum is offered only to mothers, and a treatment arm in which the curriculum is offered jointly to mothers and grandmothers. Data will be collected six months following the roll-out of the intervention to measure its impact on breastfeeding, household decision-making power, and infant health, including reported diarrheal episodes, respiratory episodes, and anthropometric data on weight and height.
External Link(s)

Registration Citation

Citation
Leight, Jessica and Simone Schaner. 2016. "Engaging women to improve breastfeeding outcomes in Tamil Nadu." AEA RCT Registry. August 04. https://doi.org/10.1257/rct.1095-1.0
Former Citation
Leight, Jessica and Simone Schaner. 2016. "Engaging women to improve breastfeeding outcomes in Tamil Nadu." AEA RCT Registry. August 04. https://www.socialscienceregistry.org/trials/1095/history/9934
Experimental Details

Interventions

Intervention(s)
India has recommended exclusive breastfeeding until six months of age only since 2004. However, it may take time for women to accept new guidelines regarding breastfeeding, especially if they are misinformed about proper infant feeding practices. One particularly important source of misinformation could be grandmothers, since new mothers often turn to their own mothers and mothers-in-law for advice. Indeed, qualitative evidence from India and other countries (Sanneving et al. 2013, Simkhada et al. 2010) suggests that grandmothers can be important facilitators of, or barriers to, high-quality maternal and child health practices. Focus group discussions in Tamil Nadu suggest that many grandmothers have relatively low levels of information about exclusive breast-feeding, and many new mothers find it challenging to defy the advice of their own mothers or mothers-in-law, even when this advice contradicts information provided by the village health nurse or other health care providers.
These observations suggest that a two-pronged approach to changing breastfeeding behavior 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). 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.

Based on this, an enhanced breastfeeding education program has been developed using behavioral change techniques. Community health workers such as village health nurses and anganwadi workers will use this curriculum to conduct family based group sessions that include mothers and grandmothers. As part of these group sessions, health workers will provide information, encourage exclusive breastfeeding by discussing benefits and problems to breastfeeding. Accordingly, community health workers will be trained on implementing the enhanced curriculum in the villages while conducting group sessions. Communication strategies employed in the curriculum is expected to help induce positive behavior change among mothers.











Intervention Start Date
2016-10-01
Intervention End Date
2017-07-31

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
IFMR
IRB Approval Date
2016-04-16
IRB Approval Number
Details not available
IRB Name
Dartmouth College
IRB Approval Date
2016-04-28
IRB Approval Number
00028433

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials