title: Participatory women's groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial.
abstract: BACKGROUND
  Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India.
  
  
  METHODS
  The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth velocity, feeding, infection control, and care-giving practices. Additional qualitative and quantitative data are collected for process and economic evaluations.
  
  
  CONCLUSIONS
  This trial will contribute to evidence on effective strategies to improve children's growth in India.
  
  
  BACKGROUND
  ISRCTN register 51505201 ; Clinical Trials Registry of India number 2014/06/004664.
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. nirmala.ekjut@gmail.com.
authors.forename: Nirmala
authors.initials: N
authors.lastname: Nair
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. prasanta.ekjut@gmail.com.
authors.forename: Prasanta
authors.initials: P
authors.lastname: Tripathy
authors.affiliation: Sitaram Bhartia Institute of Science and Research, New Delhi, India. hpssachdev@gmail.com.
authors.forename: Harshpal S
authors.initials: HS
authors.lastname: Sachdev
authors.affiliation: Public Health Foundation of India, New Delhi, India. sanghita@phfi.org.
authors.forename: Sanghita
authors.initials: S
authors.lastname: Bhattacharyya
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. rajkumar.ekjut@gmail.com.
authors.forename: Rajkumar
authors.initials: R
authors.lastname: Gope
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. sumitra.ekjut@gmail.com.
authors.forename: Sumitra
authors.initials: S
authors.lastname: Gagrai
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. shibanand.ekjut@gmail.com.
authors.forename: Shibanand
authors.initials: S
authors.lastname: Rath
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. suchitra.ekjut@gmail.com.
authors.forename: Suchitra
authors.initials: S
authors.lastname: Rath
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. rajesh.ekjut@gmail.com.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Sinha
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. swati.ekjut@gmail.com.
authors.forename: Swati Sarbani
authors.initials: SS
authors.lastname: Roy
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. suhas.p.shewale@gmail.com.
authors.forename: Suhas
authors.initials: S
authors.lastname: Shewale
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. vijay.ekjut@gmail.com.
authors.forename: Vijay
authors.initials: V
authors.lastname: Singh
authors.affiliation: Public Health Foundation of India, New Delhi, India. aradhana@phfi.org.
authors.forename: Aradhana
authors.initials: A
authors.lastname: Srivastava
authors.affiliation: Ekjut, Chakradharpur, Jharkhand, India. hemanta.ekjut@gmail.com.
authors.forename: Hemanta
authors.initials: H
authors.lastname: Pradhan
authors.affiliation: Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom. anthony.costello@ucl.ac.uk.
authors.forename: Anthony
authors.initials: A
authors.lastname: Costello
authors.affiliation: MRC Clinical Trials Unit at University College London, London, UK. a.copas@ucl.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Copas
authors.affiliation: Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom. j.skordis-worrall@ucl.ac.uk.
authors.forename: Jolene
authors.initials: J
authors.lastname: Skordis-Worrall
authors.affiliation: Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom. h.haghparast-bidgoli@ucl.ac.uk.
authors.forename: Hassan
authors.initials: H
authors.lastname: Haghparast-Bidgoli
authors.affiliation: Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom. n.saville@ucl.ac.uk.
authors.forename: Naomi
authors.initials: N
authors.lastname: Saville
authors.affiliation: Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, United Kingdom. audrey.prost@ucl.ac.uk.
authors.forename: Audrey
authors.initials: A
authors.lastname: Prost
mesh_terms: D000328:Adult; D002657:Child Development; D015362:Child Nutrition Disorders / Q000517:prevention & control*; D002675:Child, Preschool; D003150:Community Health Workers / Q000191:economics / Q000458:organization & administration*; D003362:Cost-Benefit Analysis; D003376:Counseling; D005260:Female; D006792:House Calls; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D008430:Maternal-Child Health Centers / Q000191:economics / Q000458:organization & administration*; D009035:Mothers; D009752:Nutritional Status; D010353:Patient Education as Topic / Q000191:economics / Q000458:organization & administration*; D011181:Postnatal Care; D011247:Pregnancy; D011263:Pregnancy Trimester, Third; D012424:Rural Population