title: Feasibility and effectiveness of the baby friendly community initiative in rural Kenya: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Interventions promoting optimal infant and young child nutrition could prevent a fifth of under-5 deaths in countries with high mortality. Poor infant and young child feeding practices are widely documented in Kenya, with potential detrimental effects on child growth, health and survival. Effective strategies to improve these practices are needed. This study aims to pilot implementation of the Baby Friendly Community Initiative (BFCI), a global initiative aimed at promoting optimal infant and young child feeding practices, to determine its feasibility and effectiveness with regards to infant feeding practices, nutrition and health outcomes in a rural setting in Kenya.
  
  
  METHODS
  The study, employing a cluster-randomized trial design, will be conducted in rural Kenya. A total of 12 clusters, constituting community units within the government's Community Health Strategy, will be randomized, with half allocated to the intervention and the other half to the control arm. A total of 812 pregnant women and their respective children will be recruited into the study. The mother-child pairs will be followed up until the child is 6 months old. Recruitment will last approximately 1 year from January 2015, and the study will run for 3 years, from 2014 to 2016. The intervention will involve regular counseling and support of mothers by trained community health workers and health professionals on maternal, infant and young child nutrition. Regular assessment of knowledge, attitudes and practices on maternal, infant and young child nutrition will be done, coupled with assessment of nutritional status of the mother-child pairs and morbidity for the children. Statistical methods will include analysis of covariance, multinomial logistic regression and multilevel modeling. The study is funded by the NIH and USAID through the Program for Enhanced Research (PEER) Health.
  
  
  CONCLUSIONS
  Findings from the study outlined in this protocol will inform potential feasibility and effectiveness of a community-based intervention aimed at promoting optimal breastfeeding and other infant feeding practices. The intervention, if proved feasible and effective, will inform policy and practice in Kenya and similar settings, particularly regarding implementation of the baby friendly community initiative.
  
  
  BACKGROUND
  ISRCTN03467700 ; Date of Registration: 24 September 2014.
authors.affiliation: African Population and Health Research Centre (APHRC), APHRC Campus, Kirawa Road, Off PeponiRoad, P.O. Box 10787, 00100, Nairobi, Kenya. ekimani@aphrc.org.
authors.forename: Elizabeth W
authors.initials: EW
authors.lastname: Kimani-Murage
authors.affiliation: Department of Food, Nutrition and Dietetics, Kenyatta University, School of Applied Human Sciences Complex, Conference Road, Room HE7, P.O. Box 43844, 00100, Nairobi, Kenya. jokimiywe@gmail.com.
authors.forename: Judith
authors.initials: J
authors.lastname: Kimiywe
authors.affiliation: Jhpiego, Off Riverside Drive, 14 Riverside, Arlington Block-2nd Floor, Nairobi, Kenya. mark.kabue@jhpiego.org.
authors.forename: Mark
authors.initials: M
authors.lastname: Kabue
authors.affiliation: African Population and Health Research Centre (APHRC), APHRC Campus, Kirawa Road, Off PeponiRoad, P.O. Box 10787, 00100, Nairobi, Kenya. fwekesah@aphrc.org.
authors.forename: Frederick
authors.initials: F
authors.lastname: Wekesah
authors.affiliation: PATH, ACS Plaza, 4th floor, Lenana Road, P.O. Box 76634-00508, Nairobi, Kenya. ematiri@path.org.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Matiri
authors.affiliation: African Population and Health Research Centre (APHRC), APHRC Campus, Kirawa Road, Off PeponiRoad, P.O. Box 10787, 00100, Nairobi, Kenya. nmuhia@aphrc.org.
authors.forename: Nelson
authors.initials: N
authors.lastname: Muhia
authors.affiliation: African Population and Health Research Centre (APHRC), APHRC Campus, Kirawa Road, Off PeponiRoad, P.O. Box 10787, 00100, Nairobi, Kenya. mwanjohi@aphrc.org.
authors.forename: Milka
authors.initials: M
authors.lastname: Wanjohi
authors.affiliation: African Population and Health Research Centre (APHRC), APHRC Campus, Kirawa Road, Off PeponiRoad, P.O. Box 10787, 00100, Nairobi, Kenya. pmuriuki@aphrc.org.
authors.forename: Peterrock
authors.initials: P
authors.lastname: Muriuki
authors.affiliation: Human Nutrition and Dietetics Unit, Ministry of Health, P.O. Box 43319-00100, Nairobi, Kenya. betsamburu@gmail.com.
authors.forename: Betty
authors.initials: B
authors.lastname: Samburu
authors.affiliation: Action Against Hunger (ACF), 4th Floor, Suite 17, Green House, Ngong Road, P.O. Box 39900-00623, Nairobi, Kenya. nutiycn.ke@acf-international.org.
authors.forename: James N
authors.initials: JN
authors.lastname: Kanyuira
authors.affiliation: Department of Population Medicine and Diagnostics, Program in International Nutrition, Cornell University, Ithaca, NY, USA. sera.young@cornell.edu.
authors.forename: Sera L
authors.initials: SL
authors.lastname: Young
authors.affiliation: Centre for Global Health and Human Development, Loughborough University, Loughborough, UK. p.griffiths@lboro.ac.uk.
authors.forename: Paula L
authors.initials: PL
authors.lastname: Griffiths
authors.affiliation: Centre for Global Health, Population, Poverty and Policy, ESRC Centre for Population Change, Faculty of Social and Human Science, University of Southampton, Building 58, Room 2001, Southampton, SO17 1BJ, UK. n.j.madise@soton.ac.uk.
authors.forename: Nyovani J
authors.initials: NJ
authors.lastname: Madise
authors.affiliation: International Health Institute, Brown University, Providence, RI 02903, USA. stephen_mcgarvey@brown.edu.
authors.forename: Stephen T
authors.initials: ST
authors.lastname: McGarvey
mesh_terms: D001942:Breast Feeding; D002662:Child Health Services; D003153:Community Health Services; D003376:Counseling; D005240:Feasibility Studies; D005260:Female; D006266:Health Education; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007228:Infant Nutrition Disorders / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000517:prevention & control*; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007630:Kenya; D016015:Logistic Models; D039382:Maternal Nutritional Physiological Phenomena; D009035:Mothers / Q000193:education*; D015999:Multivariate Analysis; D015596:Nutrition Assessment; D009752:Nutritional Status; D010348:Patient Care Team; D011247:Pregnancy; D015397:Program Evaluation; D012107:Research Design; D019035:Rural Health Services; D013997:Time Factors