Health Promotion Intervention to Reduce Child Morbidity (intervention)
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|ClinicalTrials.gov Identifier: NCT03810430|
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea; Nutritional||Behavioral: health promotion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking Description:||After baseline survey was carried out, two sub-districts (10 clusters each) were allocated into intervention and control clusters in a 1:1 ratio (10 intervention and 10 control clusters). This allocation of intervention and control clusters was randomly carried out and each sub district had an equal chance of being in either group. For randomization, the two sub districts were listed (1 to 2) and drew randomly by health manager there. Intervention group was informed that participants had been received the intervention, hence it was impossible to fully mask (blind) the study participants. The primary outcomes of interest were measured by observers who were not connected with the intervention implementation, in order to reduce the observer bias|
|Official Title:||Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen|
|Actual Study Start Date :||April 20, 2015|
|Actual Primary Completion Date :||December 20, 2015|
|Actual Study Completion Date :||December 31, 2018|
Active Comparator: intervention group
ten clusters (villages) were received health promotion activities during six months of interventions
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
No Intervention: control group
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.
- 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 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 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 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
- To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding. [ Time Frame: at month 6 ]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.
- change in mother hygiene, water and sanitation as well as child feeding behaviors. [ Time Frame: at month 6 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810430
|Sanaa, Yemen, +967|
|Principal Investigator:||Abdulwahed A Alserouri, Professor||Sanaa University|