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Intervention to Promote Hygiene Behavior Among School Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03942523
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 10, 2019
Information provided by (Responsible Party):
Nousheen Pradhan, Aga Khan University

Brief Summary:

Background: Poor personal hygiene and inadequate sanitation practices among young children in Low Middle Income Countries such as Pakistan can lead to critical, life-threatening illnesses such as respiratory infections, diarrheal disease, malnutrition and developmental delays. An intervention for personal/environmental hygiene practices for primary schoolchildren will be implemented at schools in urban squatter settlements of Karachi, Pakistan, aiming to improve the hygiene knowledge and practices (K&P) amongst primary schoolchildren and their mothers (participants), while identifying facilitating and impeding factors in the adoption of hygiene practices for children.

Methods: The study will be built on quasi-experimental design with mixed methods data collection approaches. To assess primary grade children and their mothers' hygiene-status, K&P survey will be held in the pre-intervention phase. This phase also includes qualitative exploration of mothers' and teachers' perceptions about children's hygiene literacy, factors facilitating and impeding the adoption of the same among school children, for which in-depth guides and focus group discussion tools will be used with teachers and mothers respectively. School physical environmental assessment will be carried out pre-post intervention. This will be followed by multi-component intervention phase with behavior change strategies to improve children's and mothers' hygiene K&P. The post-intervention phase will assess the intervention effectiveness in terms of enhancing hygiene K&P among schoolchildren and mothers, alongside exploration of mothers and teachers' insights into whether or not the intervention has brought changes in improving hygiene practices among children.

Results: Paired T-test will be done pre-post intervention to measure the differences in knowledge and practice scores between mothers' hygiene literacy and practices with their child's knowledge and practices. Similar test will also be run to assess the differences in children' hygiene knowledge and practice scores pre and post intervention. Thematic analysis will be used for qualitative data.

Discussion: Multi-component intervention aimed at improving personal and environmental hygiene among primary school children offers an opportunity to design and test various behavioral change strategies at school and home setting. The study findings will be significant in assessing the intervention effectiveness in improving children's overall hygiene.

Condition or disease Intervention/treatment Phase
Behavioral Assessment of Children Communicable Diseases in Children Behavioral: Behavior Change Communication to promote hygiene behavior Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Behavior change communication sessions will be administered to school children belonging to 1-5 grades in schools
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School-based Interventions to Promote Personal and Environmental Hygiene Among Children in Pakistan: Protocol for a Mixed Methods Study
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 20, 2020

Arm Intervention/treatment
Experimental: School Children
School children will be administered with behavioral change communication sessions as an intervention
Behavioral: Behavior Change Communication to promote hygiene behavior

Behavior Change Communication sessions will be used to promote knowledge and practices among young children and to prevent communicable diseases.

This will include, capacity building of teachers and students, health awareness sessions at the school and improving school physical environment

Primary Outcome Measures :
  1. Assessment of Improved hygiene knowledge and practices among young children through survey tool [ Time Frame: 3-4 months ]
    Changes in knowledge and practice of school children regarding hygiene will be assessed. There are no sub-scales used in the study. All knowledge and practice related responses will be measured as scores (pre-post intervention). Scores will be summed together. Less than 50 will be considered as poor, minimum and maximum score for rest of the categories are 50-75 will be considered as Good and 75-100 as Excellent. Higher values in each of the three categories will represent better outcomes for knowledge and practice.

Secondary Outcome Measures :
  1. Change prevalence of communicable diseases among young children through structured questionnaire [ Time Frame: 3-4 months ]
    This will include assessment of the change in the prevalence of communicable diseases (diarrhea, typhoid, pneumonia, oral health infections, scabies, hepatitis and mosquito borne infections) through structured questionnaire. Proportions of the children with these conditions will be used to report the change. No scales or sub-scales will be used. Proportions specific for each diseases will be averaged out pre-post intervention study.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria for Schools:

* Primary schools run by government or / NGO functional in District Malir, Gaddap town of Karachi

Exclusion Criteria for Schools:

* Consent not given by school administration.

Inclusion Criteria for Children:

  • Students enrolled in primary grade (class 1-5)
  • Informed consent given by either of the child's parents.
  • After obtaining child's parents' consent, assent obtained from children.

Exclusion Criteria for Children:

* Assent not obtained from children

Inclusion criteria for Mothers:

  • Mothers whose children are studying in grade 1-5 in selected/sample schools will be recruited.
  • Mothers available at the time of data collection
  • Mothers who gave consent

Exclusion Criteria for Mothers:

* Mothers who didn't meet the above eligibility criteria is excluded to participate.

Inclusion Criteria for Teachers:

  • Teachers who are involved in teaching grade 1-5 students in the selected schools.
  • Those who are available at the time of the study will be recruited after their informed consent.

Exclusion Criteria for Teachers:

* Those teachers who didn't give consent will be excluded.

Inclusion Criteria for Key Stakeholders:

  • District Education Officers (DEO) and District Health Officer (DHOs) who currently hold the offices will be interviewed.
  • Interviews with these respondents will only be held after obtaining their informed consent.

Exclusion Criteria for Key Stakeholders:

* Stakeholders who didn't provide consent will be excluded

Information from the National Library of Medicine

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 identifier (NCT number): NCT03942523

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Contact: Nousheen Pradhan, MSc 09202103452849438
Contact: Waliya Mughis, MSc 09202103007789110

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Aga khan University Recruiting
Karachi, Sindh, Pakistan
Contact: Nousheen A Pradhan, MSc    09202103452849438   
Sponsors and Collaborators
Aga Khan University
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Principal Investigator: Nousheen A Pradhan, MSc Senior Instructor
  Study Documents (Full-Text)

Documents provided by Nousheen Pradhan, Aga Khan University:
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Responsible Party: Nousheen Pradhan, Senior Instructor, Aga Khan University Identifier: NCT03942523    
Other Study ID Numbers: PF90/1016)
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this stage, I intend to disseminate the study results with researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases