Randomized control trial

Rural Guatemalan households split into 38 neighborhood clusters, for twelve weeks. The target population in this randomized control trial will mainly consist of infants aged below one year. Each cluster randomly assigned to water treatment with the disinfectant will be compared with the ones that continue to use their normal water treatment practices. Only households that had not previously taken part in any prior studies shall be eligible for this study. The participating households will be grouped into four neighborhoods within every village. Using a spreadsheet with a random number generator, half of the neighborhoods in each village will be assigned to the intervention group while the remaining will be assigned to the control group. Households in the intervention group will use the disinfectant which is manufactured from chemicals used in commercial water treatment plants but has been specifically designed to work fast in small quantities of water. Field workers will administer the treatment to participating households. Participants in the control group continued their normal water collection, treatment, and storage practices. A standardized questionnaire on water use will be filled weekly by each participating household to record whether each household will have had a case of diarrhea. Samples of drinking water stored by every household will also be collected by each household and measured to determine the chlorine concentration. The longitudinal prevalence of diarrhea among the 482 households will be computed as the fraction of total days with diarrhea divided by the overall number of days of observation. The prevalence of diarrhea will then be compared using a rank-sum test.
I will use data gathered from the randomized control trial to determine the existence of any adequate power to detect a variation in the prevalence of diarrhea between control children and intervention children aged below one year. I will use intention-to-treat analysis-all participants will be analyzed in the group to which they were randomized. The longitudinal prevalence of diarrhea among the 482 households will be computed as the number of person-days of diarrhea divided by the number of person-days of observation. A reduction in the prevalence of diarrhea among intervention households will be used as the basis for accepting or rejecting the hypothesis. Any insignificant reduction in prevalence would lead to rejection of the hypothesis.
A randomized control trial is necessary in performing this evaluation in order to balance the control and treatment groups in each participating population sample.