- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810430
Health Promotion Intervention to Reduce Child Morbidity (intervention)
January 20, 2019 updated by: Mansour Abdu Salah Al-taj, Sana'a University
Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sanaa, Yemen, +967
- Sanaa University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: intervention group
ten clusters (villages) were received health promotion activities during six months of interventions
|
health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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at month 6
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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.
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at month 6
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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
|
at month 6
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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
|
at month 6
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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
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at month6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at month 6
|
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.
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at month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdulwahed A Alserouri, Professor, Sanaa University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 20, 2015
Primary Completion (ACTUAL)
December 20, 2015
Study Completion (ACTUAL)
December 31, 2018
Study Registration Dates
First Submitted
January 7, 2019
First Submitted That Met QC Criteria
January 17, 2019
First Posted (ACTUAL)
January 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 20, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202016000191-85
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
once the results will be ready, we will decide with whom and how can we share the data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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