Diarrhea; NutritionalinterventionNCT03810430
Health Promotion Intervention to Reduce Child Morbidity
A study testing health promotion in people with Diarrhea; Nutritional, run by Sana'a University at 1 site in Yemen.
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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Diarrhea; Nutritional
- What is being tested?
- health promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteYemen
- Study dates
- 20 Apr 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diarrhea; Nutritional
- Being tested
- health promotion
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health promotionBehavioural
health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | ten clusters (villages) were received health promotion activities during six months of interventions Receives: Behavioral: health promotion |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at month 6
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.
Measured: at month 6
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
Measured: at month 6
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
Measured: at month 6
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
Measured: at month6
Secondary outcomes (2)
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.
Measured: at month 6
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.
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start20 Apr 2015
- Primary completion20 Dec 2015
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea; NutritionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansour Abdu Salah Al-taj, Sana'a University
- Investigators
- Abdulwahed A Alserouri, Professor, Principal investigator, Sanaa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810430
- Sponsor's protocol ID
- 202016000191-85
- Acronym
- intervention
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: once the results will be ready, we will decide with whom and how can we share the data
Publications
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.
PubMed 18556606
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen
- ClinicalTrials.gov ID
- NCT03810430
- Acronym / sponsor ID
- intervention / 202016000191-85
- Conditions
- Diarrhea; Nutritional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 20 Dec 2015 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Behavioral: health promotionten clusters (villages) were received health promotion activities during six months of interventions |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health promotionhealth promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm | Behavioural | intervention group |
Primary outcome
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
2 secondary outcomes
To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.
Time frame: at month 6
change in mother hygiene, water and sanitation as well as child feeding behaviors.
Time frame: at month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 18556606Aiello 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.
- Individual participant dataSharing planned: Undecided. once the results will be ready, we will decide with whom and how can we share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdulwahed A Alserouri, Professor principal investigator
Sanaa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health promotion in people with Diarrhea; Nutritional, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prevalence of diarrhea among children under five years old (time frame: at month 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.