An interventional study of health promotion in Diarrhea; Nutritional, sponsored by Sana'a University. Completed at 1 site in Yemen. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2019-01-23.
Sponsored by Sana'a University · Not applicable, Interventional, and Prevention
While household-level water, sanitation and hygiene has been investigated extensively, this is the first comprehensive study to investigate the impact of improved water, sanitation and hygiene and nutrition at household on child health in Yemen.
This study was conducted in Hufash district, Al-Mahweet Province, which is located on the southwest of the capital Sana'a, and takes about (113)kilometers from it. The study aimed to highlight the key role of the community based interventions in reducing child morbidity and mortality in rural Yemen.A community - randomized controlled field trail was implemented to evaluate the role of public health promotion on reducing child diarrhea, acute respiratory infection, nutrition, immunization in children under age of five at enrollment over a six month of study period. Due to the nature of the study, blinding is not possible so some measures would be done to reduce the non-blinding bias like, to keep the study staff blinded as much as possible, the observers and survey staff were not informed about the study design. The sample size required to measure the primary and secondary outcomes before and after the intervention in both groups was estimated using STATA 14.0.Based on data of a previous meta analysis, estimates of required sample size assumed a 20% reduction in the proportion of diarrhea. Intra-cluster correlation coefficient (ICC) was set low at 0.04 and the cluster sizes (number of subjects in a cluster, m) were expected to be 18. The sample size was multiplied by a design effect of 1.68, calculated using DE=1+ICC (m-1), to accommodate the clustering effect. The sample was further adjusted for a potential 20% loss to follow-up over one year, thus requiring a sample of 180 per group. Therefore, the present study estimated that a total of 20 clusters inhabited by 358 households with child aged 6 to 59 months would have 80% power to detect the 20% reduction in the proportion in diarrhea at 5% level of significance.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 360 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
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Exclusion Criteria:
ten clusters (villages) were received health promotion activities during six months of interventions
Behavioral: health promotion
10 clusters (villages) were not received intervention during the intervention period and by the end of study, it will be compared with the intervention group to measure the change in the primary and secondary outcomes.
health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm
Change in prevalence of diarrhea among children under five years old
At the end of the six month trial, each household in intervention and control groups are visited by trained field workers to collect morbidity data from mothers or caretakers regarding the daily occurrence of signs and symptoms of child diarrhea. The case definition of diarrhea was 3 or more loose or watery stools over a 24-hour period prior to data collocation.
Time frame: at month 6
change in prevalence of acute respiratory infection among children under five years old
At the end of the six month trial, each household in intervention and control groups are visited by trained field workers to collect morbidity data from mothers or caretakers regarding the signs and symptoms of child acute respiratory infection. The case definition of acute respiratory infection was as cough or difficulties with breathing by a child with a raised respiratory rate on two consecutive measurement over a 2 weeks period prior to data collection.
Time frame: at month 6
Change in weight-for-age z-score (WAZ) among children age 6 - 59 months
Investigators used 2006 WHO growth reference to calculate WAZ score. Child was considered underweight when child weight for age Z score is below - 2 of the median WHO growth standards
Time frame: at month 6
Change in weight-for-height z-score (WHZ) among children age 6 - 59 months
Investigators used 2006 WHO growth reference to calculate WHZ score. Child was considered wasting when child weight for height Z score is below - 2 of the median WHO growth standards
Time frame: at month 6
Change in height-for-age z-score (HAZ) among children age 6 - 59 months
Investigators used 2006 WHO growth reference to calculate HAZ score. Child was considered stunted when child height for age Z score is below - 2 of the median WHO growth standards
Time frame: at month6
To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.
Proportion of mothers with improved knowledge regarding water, sanitation and Hygiene as well as child feeding. Face to face interview are conducted with mothers or care givers to measure the level of mother knowledge about water, sanitation and hygiene as well as child feeding.
Time frame: at month 6
change in mother hygiene, water and sanitation as well as child feeding behaviors.
Proportion of households with improved water ; proportion of households practicing. To determine water handling practices, hygiene and sanitation practices and child feeding practices, an observation check list is carried out hand washing with soap at the five critical times(before eating, after using latrine, before feeding the child, before cooking and after cleaning child feces); proportion of households disposing of child feces in an improved latrine; proportion of mothers with good child feeding practice.
Time frame: at month 6
Plan to share: Undecided — once the results will be ready, we will decide with whom and how can we share the data
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Sana'a University