<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810430</url>
  </required_header>
  <id_info>
    <org_study_id>202016000191-85</org_study_id>
    <nct_id>NCT03810430</nct_id>
  </id_info>
  <brief_title>Health Promotion Intervention to Reduce Child Morbidity</brief_title>
  <acronym>intervention</acronym>
  <official_title>Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sana'a University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sana'a University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      While household-level water, sanitation and hygiene has been investigated extensively, this&#xD;
      is the first comprehensive study to investigate the impact of improved water, sanitation and&#xD;
      hygiene and nutrition at household on child health in Yemen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted in Hufash district, Al-Mahweet Province, which is located on the&#xD;
      southwest of the capital Sana'a, and takes about (113)kilometers from it. The study aimed to&#xD;
      highlight the key role of the community based interventions in reducing child morbidity and&#xD;
      mortality in rural Yemen.A community - randomized controlled field trail was implemented to&#xD;
      evaluate the role of public health promotion on reducing child diarrhea, acute respiratory&#xD;
      infection, nutrition, immunization in children under age of five at enrollment over a six&#xD;
      month of study period. Due to the nature of the study, blinding is not possible so some&#xD;
      measures would be done to reduce the non-blinding bias like, to keep the study staff blinded&#xD;
      as much as possible, the observers and survey staff were not informed about the study design.&#xD;
      The sample size required to measure the primary and secondary outcomes before and after the&#xD;
      intervention in both groups was estimated using STATA 14.0.Based on data of a previous meta&#xD;
      analysis, estimates of required sample size assumed a 20% reduction in the proportion of&#xD;
      diarrhea. Intra-cluster correlation coefficient (ICC) was set low at 0.04 and the cluster&#xD;
      sizes (number of subjects in a cluster, m) were expected to be 18. The sample size was&#xD;
      multiplied by a design effect of 1.68, calculated using DE=1+ICC (m-1), to accommodate the&#xD;
      clustering effect. The sample was further adjusted for a potential 20% loss to follow-up over&#xD;
      one year, thus requiring a sample of 180 per group. Therefore, the present study estimated&#xD;
      that a total of 20 clusters inhabited by 358 households with child aged 6 to 59 months would&#xD;
      have 80% power to detect the 20% reduction in the proportion in diarrhea at 5% level of&#xD;
      significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2015</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in prevalence of diarrhea among children under five years old</measure>
    <time_frame>at month 6</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in prevalence of acute respiratory infection among children under five years old</measure>
    <time_frame>at month 6</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in weight-for-age z-score (WAZ) among children age 6 - 59 months</measure>
    <time_frame>at month 6</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in weight-for-height z-score (WHZ) among children age 6 - 59 months</measure>
    <time_frame>at month 6</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in height-for-age z-score (HAZ) among children age 6 - 59 months</measure>
    <time_frame>at month6</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.</measure>
    <time_frame>at month 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in mother hygiene, water and sanitation as well as child feeding behaviors.</measure>
    <time_frame>at month 6</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Diarrhea; Nutritional</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ten clusters (villages) were received health promotion activities during six months of interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>health promotion</intervention_name>
    <description>health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one child aged between 6 - 59 months&#xD;
&#xD;
          -  Family planning to stay in their home for the next 12 months&#xD;
&#xD;
          -  Written consent taken from the head of household&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child had chronic diseases or severely malnourished.&#xD;
&#xD;
          -  Family that might leave their house before one year.&#xD;
&#xD;
          -  Household that the lord of house refuses to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdulwahed A Alserouri, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanaa University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanaa University</name>
      <address>
        <city>Sanaa</city>
        <zip>+967</zip>
        <country>Yemen</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Yemen</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>18556606</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sana'a University</investigator_affiliation>
    <investigator_full_name>Mansour Abdu Salah Al-taj</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>once the results will be ready, we will decide with whom and how can we share the data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810430
org study id: 202016000191-85
nct id: NCT03810430
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
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.
primary purpose: Prevention
masking: Single (Participant)
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
measure: Change in prevalence of diarrhea among children under five years old
time frame: at month 6
description: 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.
measure: change in prevalence of acute respiratory infection among children under five years old
time frame: at month 6
description: 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.
measure: Change in weight-for-age z-score (WAZ) among children age 6 - 59 months
time frame: at month 6
description: 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
measure: Change in weight-for-height z-score (WHZ) among children age 6 - 59 months
time frame: at month 6
description: 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
measure: Change in height-for-age z-score (HAZ) among children age 6 - 59 months
time frame: at month6
description: 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
measure: To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.
time frame: at month 6
description: 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.
measure: change in mother hygiene, water and sanitation as well as child feeding behaviors.
time frame: at month 6
description: 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.
arm group label: intervention group
arm group type: Active Comparator
description: ten clusters (villages) were received health promotion activities during six months of interventions
arm group label: control group
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: health promotion
description: health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm
arm group label: intervention group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: Abdulwahed A Alserouri, Professor
role: Principal Investigator
affiliation: Sanaa University
facility: 
country: Yemen
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.
PMID: 18556606
responsible party type: Principal Investigator
investigator affiliation: Sana'a University
investigator full name: Mansour Abdu Salah Al-taj
investigator title: principle investigator
mesh term: Diarrhea
sharing ipd: Undecided
ipd description: once the results will be ready, we will decide with whom and how can we share the data