Iron fortification and psychosocial stimulation to foster early childhood development in rural India
Last registered on March 05, 2018

Pre-Trial

Trial Information
General Information
Title
Iron fortification and psychosocial stimulation to foster early childhood development in rural India
RCT ID
AEARCTR-0002696
Initial registration date
March 05, 2018
Last updated
March 05, 2018 10:51 AM EST
Location(s)
Region
Primary Investigator
Affiliation
University of Göttingen
Other Primary Investigator(s)
PI Affiliation
University of Goettingen
PI Affiliation
University of Goettingen
Additional Trial Information
Status
On going
Start date
2016-11-20
End date
2018-08-30
Secondary IDs
Abstract
Malnutrition and lack of cognitive stimulation are primary risk factors of early childhood development and highly correlated with poverty. Particular children growing up in highly resource constrained environments often fail to reach their developmental potential, which adversely affects socio-economic outcomes later in life.
This trial tests at large scale a set of potentially cost-effective tools to improve cognitive, language, socioemotional and motor development of toddlers in rural Bihar, India. We evaluate three interventions with 2000 children aged between 10 and 32 months. The first intervention addresses iron deficiency anemia, a biological risk factor of early development. We distributed a small cast iron ingot shaped like a tulsi leaf, labelled the Lucky Iron Leaf, for iron fortification. By placing the Lucky Iron Leaf in a cooking vessel of boiling water it releases iron into the water and the food. The second intervention addresses cognitive stimulation, a psychosocial risk factor of early development. We conducted four home visits during which dialogic reading was trained and practiced with the primary caregiver and her child. Dialogic reading refers to a method of looking at picture books which emphasizes strategic questioning and feedback in order to encourage children to speak and learn. For daily practice of dialogic reading three picture books were given to the caregiver and her child. Adding on intervention two, the third intervention is a dialogic reading calendar and serves as a reminder and encouragement for daily dialogic reading. We distributed colourful calendars, containing the months of the year, relevant moon periods and religious holidays, and caregivers use stickers to indicate whenever they practiced dialogic reading.
The trial follows an individually randomised controlled design. We randomly allocated caregiver-child pairs to one of six groups: (i) Lucky Iron Leaf group, (ii) dialogic reading group without a calendar, (iii) dialogic reading group with a calendar, (vi) Lucky Iron Leaf and dialogic reading group without a calendar, (v) Lucky Iron Leaf and dialogic reading group with a calendar, and (vi) no-intervention group.
We expect the iron fortification intervention to reduce iron deficiency anemia and consequently to improve cognitive and motor development. We expect the dialogic reading intervention to show positive effects on the child’s expressive and receptive vocabulary and socioemotional development. Further we expect these effects to be reinforced among the dialogic reading calendar groups.
External Link(s)
Registration Citation
Citation
Ebert, Cara, Esther Heesemann and Sebastian Vollmer. 2018. "Iron fortification and psychosocial stimulation to foster early childhood development in rural India." AEA RCT Registry. March 05. https://www.socialscienceregistry.org/trials/2696/history/26308
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Experimental Details
Interventions
Intervention(s)
The trial consists of three interventions. The first intervention is a household level distribution of a cooking utensil for iron fortification. The cooking utensil is a small cast iron ingot shaped like a tulsi leaf, labelled the Lucky Iron LeafTM. By placing the Lucky Iron LeafTM in a cooking vessel of boiling water it releases iron into the water and the food. The second intervention is a home-based psychosocial stimulation intervention. During four home-visits we trained caregivers in the methods of dialogic reading and practiced it. Additionally, we distributed three picture books for the caregivers to keep and to practice daily dialogic reading with their toddlers. The third intervention is a dialogic reading calendar and adds on intervention two. The colourful calendars contain the months of the year, relevant moon periods and religious holidays, and caregivers use stickers to indicate whenever they practiced dialogic reading.
Intervention Start Date
2016-11-21
Intervention End Date
2017-03-03
Primary Outcomes
Primary Outcomes (end points)
- Early childhood development
- Hemoglobin and iron deficiency anaemia
Primary Outcomes (explanation)
Early childhood development is measured using an adapted and translated to Hindi version of the German early childhood development test FREDI 0-3 (Mähler, Cartschau and Rohleder 2016). The test assesses four areas of development: cognitive, language (receptive and expressive), motor (fine or gross), and socio-emotional development. The test includes parent questions and facilitator administered items with child.

Haemoglobin concentration is measured on the spot from capillary blood using hemocues. Iron deficiency anemia is derived based on WHO threshold of haemoglobin values.
Secondary Outcomes
Secondary Outcomes (end points)
- Home environment / parenting quality
- Child health indicators
- Stunting
- Waisting
- Underweight
- Head circumference
- Maternal health, behavior and living circumstances
- Family nutrition
- Health care utilization
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study is a randomised controlled trial. Intervention groups were randomised at the household level. We randomly allocated households with caregiver-child pairs to one of six groups: (i) Lucky Iron Leaf group, (ii) dialogic reading group without a calendar, (iii) dialogic reading group with a calendar, (vi) Lucky Iron Leaf and dialogic reading group without a calendar, (v) Lucky Iron Leaf and dialogic reading group with a calendar, and (vi) no-intervention group. Because the dialogic reading calendar is an add-on intervention, the dialogic reading groups with and without calendar are each half the size of the pure lucky Iron LeafTM and control group.
Experimental Design Details
Randomization Method
Randomization took place in a two-stage procedure. First, we randomly allocated individuals into 4 groups: (i) Lucky Iron Leaf group, (ii) dialogic reading group, (iii) Lucky Iron Leaf and dialogic reading group, and (iv) no-intervention group. The assignment of households into these groups was random with equal probability of 0.25. A uniformly distributed set of random numbers between 0 and 1 were allocated to each household using the statistical software Stata13. Next, households were sorted in ascending order of the generated random number. The first 500 households formed the first group, households 501 to 1000 formed the second group, households 1001 to 1500 formed the third group, and households 1501 to 2000 formed the fourth group.

In a second step, dialogic reading groups were rerandomized into calendar and no calendar sub-groups using the same procedure as explained above. The first 500 households formed the first group and households 501 to 1000 formed the second group.

This leads to the following six groups with selection probability indicated in parentheses: (i) Lucky Iron Leaf group (p=0.25), (ii) dialogic reading group without a calendar (p=0.125), (iii) dialogic reading group with a calendar (p=0.125), (vi) Lucky Iron Leaf and dialogic reading group without a calendar (p=0.125), (v) Lucky Iron Leaf and dialogic reading group with a calendar (p=0.125), and (vi) no-intervention group (p=0.25).

The generation of the allocation sequence and the assignment to interventions was done by researchers of the University of Goettingen.
Randomization Unit
Household level
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
-
Sample size: planned number of observations
2000
Sample size (or number of clusters) by treatment arms
The sample consists of a total of 2000 households.
500 households the pure control group
500 households the pure Lucky Iron LeafTM group
250 in the Lucky Iron LeafTM + Dialogic reading group
250 in the Lucky Iron LeafTM + Dialogic reading group + Calendar group
250 in the pure Dialogic reading group
250 in the Dialogic reading group + Calendar group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
INSTITUTE ETHICS COMMITTEE INDIAN INSTITUTE OF TECHNOLOGY GANDHINAGAR
IRB Approval Date
2017-10-10
IRB Approval Number
N/A
IRB Name
Ethics committee of the University of Göttingen (Germany)
IRB Approval Date
2016-10-28
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