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Clinical Trials/NCT03810430
NCT03810430
Completed
Not Applicable

Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen

Sana'a University1 site in 1 country360 target enrollmentApril 20, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diarrhea; Nutritional
Sponsor
Sana'a University
Enrollment
360
Locations
1
Primary Endpoint
Change in weight-for-height z-score (WHZ) among children age 6 - 59 months
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2015
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mansour Abdu Salah Al-taj

principle investigator

Sana'a University

Eligibility Criteria

Inclusion Criteria

  • At least one child aged between 6 - 59 months
  • Family planning to stay in their home for the next 12 months
  • Written consent taken from the head of household

Exclusion Criteria

  • Child had chronic diseases or severely malnourished.
  • Family that might leave their house before one year.
  • Household that the lord of house refuses to participate.

Outcomes

Primary Outcomes

Change in weight-for-height z-score (WHZ) among children age 6 - 59 months

Time Frame: at month 6

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

change in prevalence of acute respiratory infection among children under five years old

Time Frame: at month 6

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.

Change in weight-for-age z-score (WAZ) among children age 6 - 59 months

Time Frame: at month 6

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

Change in prevalence of diarrhea among children under five years old

Time Frame: at month 6

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.

Change in height-for-age z-score (HAZ) among children age 6 - 59 months

Time Frame: at month6

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

Secondary Outcomes

  • change in mother hygiene, water and sanitation as well as child feeding behaviors.(at month 6)
  • To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.(at month 6)

Study Sites (1)

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