Title,Url,Last update date,Published at,First registered on,RCT_ID,DOI Number,Primary Investigator,Status,Start date,End date,Keywords,Country names,Other Primary Investigators,Jel code,Secondary IDs,Abstract,External Links,Sponsors,Partners,Intervention start date,Intervention end date,Intervention,Primary outcome end points,Primary outcome explanation,Secondary outcome end points,Secondary outcome explanation,Experimental design,Experimental design details,Randomization method,Randomization unit,Sample size number clusters,Sample size number observations,Sample size number arms,Minimum effect size,IRB,Analysis Plan Documents,Intervention completion date,Data collection completion,Data collection completion date,Number of clusters,Attrition correlated,Total number of observations,Treatment arms,Public data,Public data url,Program files,Program files url,Post trial documents csv,Relevant papers for csv Iron fortification and psychosocial stimulation to foster early childhood development in rural India,http://www.socialscienceregistry.org/trials/2696,"March 05, 2018",2018-03-05 10:51:27 -0500,2018-03-05,AEARCTR-0002696,10.1257/rct.2696-1.0,Esther Heesemann eheesem@gwdg.de,on_going,2016-11-20,2018-08-30,"[""education"", ""health"", ""Early childhood development"", ""psychosocial stimulation"", ""iron fortification"", ""dialogic reading"", ""book sharing"", ""Lucky Iron Leaf""]",Private,Sebastian Vollmer (sebastian.vollmer@wiwi.uni-goettingen.de) University of Goettingen; Cara Ebert (cara.ebert@wiwi.uni-goettingen.de) University of Goettingen,"D04, I12, I15, J13, J24, O12, O15, O53","","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.","","","",2016-11-21,2017-03-03,"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.","- Early childhood development - Hemoglobin and iron deficiency anaemia","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. ","- Home environment / parenting quality - Child health indicators - Stunting - Waisting - Underweight - Head circumference - Maternal health, behavior and living circumstances - Family nutrition - Health care utilization","","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.","","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.",Household level,-,2000,"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.","","Name: INSTITUTE ETHICS COMMITTEE INDIAN INSTITUTE OF TECHNOLOGY GANDHINAGAR Approval_number: N/A Approval_date: 2017-10-10 Name: Ethics committee of the University of Göttingen (Germany) Approval_number: N/A Approval_date: 2016-10-28 ",None,,,,"",,"","",,"",,"","",""