title: The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.
abstract: BACKGROUND
  Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth).
  
  
  RESULTS
  We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors.
  
  
  CONCLUSIONS
  The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.
authors.affiliation: Network for Engineering and Economics Research and Management (NEERMAN), Mumbai, Maharashtra, India; School of Public Health, University of California, Berkeley, California, United States of America.
authors.forename: Sumeet R
authors.initials: SR
authors.lastname: Patil
authors.affiliation: School of Public Health, University of California, Berkeley, California, United States of America.
authors.forename: Benjamin F
authors.initials: BF
authors.lastname: Arnold
authors.affiliation: Stanford School of Medicine, Stanford University, Stanford, California, United States of America.
authors.forename: Alicia L
authors.initials: AL
authors.lastname: Salvatore
authors.affiliation: Water and Sanitation Program, the World Bank, Washington (D.C.), United States of America.
authors.forename: Bertha
authors.initials: B
authors.lastname: Briceno
authors.affiliation: National Institute for Cholera and Enteric Diseases, Kolkata, West Bengal, India.
authors.forename: Sandipan
authors.initials: S
authors.lastname: Ganguly
authors.affiliation: School of Public Health, University of California, Berkeley, California, United States of America.
authors.forename: John M
authors.initials: JM
authors.lastname: Colford
authors.affiliation: School of Public Health, University of California, Berkeley, California, United States of America; Haas School of Business, University of California, Berkeley, California, United States of America.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Gertler
mesh_terms: D000740:Anemia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D002669:Child Welfare; D002675:Child, Preschool; D016000:Cluster Analysis; D003672:Defecation; D003967:Diarrhea / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D006128:Growth; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007229:Infant Welfare; D008297:Male; D010272:Parasitic Diseases / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D011634:Public Health / Q000193:education* / Q000639:trends; D012424:Rural Population; D012499:Sanitation / Q000379:methods*; D014038:Toilet Facilities / Q000706:statistics & numerical data