NCT03942523

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 1, 2019

Last Update Submit

May 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of Improved hygiene knowledge and practices among young children through survey tool

    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.

    3-4 months

Secondary Outcomes (1)

  • Change prevalence of communicable diseases among young children through structured questionnaire

    3-4 months

Study Arms (1)

School Children

EXPERIMENTAL

School children will be administered with behavioral change communication sessions as an intervention

Behavioral: Behavior Change Communication to promote hygiene behavior

Interventions

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

School Children

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \* Consent not given by school administration.
  • 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.
  • \* Assent not obtained from children
  • 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
  • \* Mothers who didn't meet the above eligibility criteria is excluded to participate.
  • 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.
  • \* Those teachers who didn't give consent will be excluded.
  • 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.
  • \* Stakeholders who didn't provide consent will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga khan University

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (7)

  • Vivas AP, Gelaye B, Aboset N, Kumie A, Berhane Y, Williams MA. Knowledge, attitudes and practices (KAP) of hygiene among school children in Angolela, Ethiopia. J Prev Med Hyg. 2010 Jun;51(2):73-9.

    PMID: 21155409BACKGROUND
  • Niehaus MD, Moore SR, Patrick PD, Derr LL, Lorntz B, Lima AA, Guerrant RL. Early childhood diarrhea is associated with diminished cognitive function 4 to 7 years later in children in a northeast Brazilian shantytown. Am J Trop Med Hyg. 2002 May;66(5):590-3. doi: 10.4269/ajtmh.2002.66.590.

    PMID: 12201596BACKGROUND
  • Oliveira D, Ferreira FS, Atouguia J, Fortes F, Guerra A, Centeno-Lima S. Infection by Intestinal Parasites, Stunting and Anemia in School-Aged Children from Southern Angola. PLoS One. 2015 Sep 15;10(9):e0137327. doi: 10.1371/journal.pone.0137327. eCollection 2015.

    PMID: 26371758BACKGROUND
  • Sarkar M. Personal hygiene among primary school children living in a slum of Kolkata, India. J Prev Med Hyg. 2013 Sep;54(3):153-8.

    PMID: 24783893BACKGROUND
  • Haque SE, Rahman M, Itsuko K, Mutahara M, Kayako S, Tsutsumi A, Islam MJ, Mostofa MG. Effect of a school-based oral health education in preventing untreated dental caries and increasing knowledge, attitude, and practices among adolescents in Bangladesh. BMC Oral Health. 2016 Mar 25;16:44. doi: 10.1186/s12903-016-0202-3.

    PMID: 27016080BACKGROUND
  • 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: 18556606BACKGROUND
  • Pradhan NA, Mughis W, Ali TS, Naseem M, Karmaliani R. School-based interventions to promote personal and environmental hygiene practices among children in Pakistan: protocol for a mixed methods study. BMC Public Health. 2020 Apr 14;20(1):481. doi: 10.1186/s12889-020-08511-0.

Study Officials

  • Nousheen A Pradhan, MSc

    Senior Instructor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nousheen Pradhan, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Behavior change communication sessions will be administered to school children belonging to 1-5 grades in schools
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 8, 2019

Study Start

December 21, 2018

Primary Completion

December 30, 2019

Study Completion

July 20, 2020

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

At this stage, I intend to disseminate the study results with researchers.

Locations