Clinical trial NCT03810430: Health Promotion Intervention to Reduce Child Morbidity
Official title: Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea; Nutritional
Lead sponsor: Sana'a University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The frame work used in this study depends on the Evo-Eco theory of behavior change.This approach consists of five steps; assess, build, create, develop and evaluate (A, B, C, D and E). In the assessment steps, the researcher made a review about the role of water, hygiene and infant feeding promotion in reducing child morbidity and changing mothers' behavior. Based on this review and experience, the researcher developed a baseline questionnaire that was used two months ago before starting the intervention. Based on the results of baseline survey and literature, the researcher with expert team developed the health promotion messages. After developing the messages, interventions took six months. Furthermore, the implementation of the health promotion intervention was at household and community level. Two months later of performing the intervention, the post intervention survey was carried out to measure the primary and secondary outcome of the interventions.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in prevalence of diarrhea among children under five years old
timeFrame: at month 6
measure: change in prevalence of acute respiratory infection among children under five years old
timeFrame: at month 6
measure: Change in weight-for-age z-score (WAZ) among children age 6 - 59 months
timeFrame: at month 6
measure: Change in weight-for-height z-score (WHZ) among children age 6 - 59 months
timeFrame: at month 6
measure: Change in height-for-age z-score (HAZ) among children age 6 - 59 months
timeFrame: at month6
Secondary outcomes:
measure: To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.
timeFrame: at month 6
measure: change in mother hygiene, water and sanitation as well as child feeding behaviors.
timeFrame: at month 6
Other outcomes:
Locations:
city: Sanaa
country: Yemen
facility: Sanaa University
Study officials:
affiliation: Sanaa University
name: Abdulwahed A Alserouri, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.