Health Promotion Intervention to Reduce Child Morbidity

Diarrhea; Nutritional Clinical Trial

— intervention  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810430
• Other study ID #: 202016000191-85
• Status: Completed
• Phase: N/A
• Start date: April 20, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Sana'a University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 31, 2018
• Est. primary completion date: December 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea; Nutritional

Intervention

Behavioral:
• health promotion
health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm

Locations

Country	Name	City	State
Yemen	Sanaa University	Sanaa

Sponsors (1)

Lead Sponsor	Collaborator
Sana'a University

Country where clinical trial is conducted

Yemen, 

References & Publications (1)

Aiello AE, Coulborn RM, Perez V, Larson EL. Effect of hand hygiene on infectious disease risk in the community setting: a meta-analysis. Am J Public Health. 2008 Aug;98(8):1372-81. doi: 10.2105/AJPH.2007.124610. Epub 2008 Jun 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at month 6
Primary	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.	at month 6
Primary	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	at month 6
Primary	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	at month 6
Primary	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	at month6
Secondary	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.	at month 6
Secondary	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.	at month 6