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Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses

Primary Purpose

Malnutrition, Child, Intestinal Worms

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children
Sponsored by
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition, Child focused on measuring Malnutrition, Intestinal worm infestation, School nurse, Primary school children

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The primary school children who are studying in class 1 to class 5 among male, female or others gender.
  • The children's parents or legal guardians would like to give consent and are willing to participate in the study.
  • Those, who will be agreed to receive health check-ups, answering questionnaire and are willing to give the sample for laboratory investigation.
  • Who will stay in the same school and area till study completion.

Exclusion Criteria:

  • The child is absent from school during the health checkup periods (at baseline) due to severe illness or without any reason and information.
  • Who does not want to give consent and is not willing to participate.
  • Who does not want to share their information and does not want to give the sample for laboratory investigations.

Sites / Locations

  • North South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Comparison group

Arm Description

Health assessment (health checkup) and health awareness program to reduce malnutrition and helminth infestation among primary school children

Health assessment (health checkup) was provided but no health educational intervention during the intervention period

Outcomes

Primary Outcome Measures

Changes in malnutrition rate among primary school children
The primary outcome will be evaluated by anthropometric health assessment (Body mass index). To calculate BMI, the body weight and height will be used following the BMI formula (BMI = weight (kg) / (height)^2 (m)^2) provided by World Health Organization (WHO). Children's nutritional status and BMI-for-age will be measured by comparing the z- scores against the WHO growth reference 2007 tables for 5-19 years. The cut-off values for overweight and obesity are > + 1SD, > + 2SD respectively. On the other hand, the cut-off value for thinness is <- 2SD>.

Secondary Outcome Measures

Change of the prevalence of intestinal worm infestation among primary school children
Evaluate by health assessment and laboratory test for helminth ova and the parasite
Change of the children's eating and drinking behavior, and health-related hygiene behavior
Evaluate by using a questionnaire which is developed by the researcher
Change of the awareness and knowledge regarding malnutrition and intestinal worm infestation
Evaluate by using a questionnaire which is developed by the researcher
Change of the frequency and number of school absent days among the children
Evaluate by using a questionnaire which is developed by the researcher
Measuring the changes of Health-related quality of life (HRQoL) of the children
Evaluate by using KIDSCREEN survey form, parents' version

Full Information

First Posted
August 11, 2021
Last Updated
March 2, 2023
Sponsor
Hiroshima University
Collaborators
North South University
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1. Study Identification

Unique Protocol Identification Number
NCT05012592
Brief Title
Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses
Official Title
Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
North South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Title: Reducing malnutrition and helminthic infectious disease among primary school children by the school nurses: School-based non-randomized study in a developing country Introduction: Globally, malnutrition alone with the infectious disease a widespread problem among primary school (5 to 12 years) children. Infectious diseases such as worm infestations are aggravated with nutritional disorders which most often lead to anemia and several complications. The prevalence of malnutrition and intestinal worm infestation/ helminthic infection is still high and the awareness level of those issues is immensely poor. However, there are limited studies that evaluated the impact of increasing health awareness by the development of the Health Awareness Program for Primary School Children (HAPSC) which is conducted by the experimentally placed school nurse in Bangladesh. Objective: To increase health awareness and knowledge towards reducing malnutrition and intestinal worm infestation by implement and evaluate the impact of the Health Awareness Program for Primary School children (HAPSC) in Bangladesh. Methods: Design: A prospective, open-label, parallel-group (1:1), cluster non-randomization controlled trial (NRCT) Site and sample: School children from four primary schools in the rural areas of North Matlab at Chandpur district at Chittagong division in Bangladesh. Duration: The duration of this study is from August 2021 to March 2024 (32nd months). Outcome variables: Primary: changes in malnutrition among primary school children. Secondary: Evaluate and reduce the prevalence of intestinal worm infestation, increase awareness and knowledge regarding malnutritional and intestinal worm infestation, improvement of health behavior (eating and hygiene), frequency of school absent days, and health-related quality of life. Conclusion: Health education by the health professional in the school setting may be an effective method for improving health behavior, and increasing awareness and knowledge levels about malnutrition and intestinal worm infestation from early childhood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child, Intestinal Worms
Keywords
Malnutrition, Intestinal worm infestation, School nurse, Primary school children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
604 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Health assessment (health checkup) and health awareness program to reduce malnutrition and helminth infestation among primary school children
Arm Title
Comparison group
Arm Type
No Intervention
Arm Description
Health assessment (health checkup) was provided but no health educational intervention during the intervention period
Intervention Type
Behavioral
Intervention Name(s)
Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children
Intervention Description
This interventional study period started from September 2021 up to September 2022 (13 months) by school nurses to implement HAPSC. After completing four to five months of the educational session the school nurse will collect midline follow-up data and the endline data will be collected at the end of the interventional study. In this period a total of nine months (except annual leave) will be considered an interventional education period. The intervention group will receive one educational session per week every month. School nurses will be assigned for each class to provide health education. Each session will be conducted for a maximum of 45 minutes. The community worker will be assigned to assist the school nurse and they will communicate with the child's parents about their child's healthy nutrition and good hygiene practice. The significance of healthy eating and hygiene behavior for the children will be shared with the child's parents or guardians properly.
Primary Outcome Measure Information:
Title
Changes in malnutrition rate among primary school children
Description
The primary outcome will be evaluated by anthropometric health assessment (Body mass index). To calculate BMI, the body weight and height will be used following the BMI formula (BMI = weight (kg) / (height)^2 (m)^2) provided by World Health Organization (WHO). Children's nutritional status and BMI-for-age will be measured by comparing the z- scores against the WHO growth reference 2007 tables for 5-19 years. The cut-off values for overweight and obesity are > + 1SD, > + 2SD respectively. On the other hand, the cut-off value for thinness is <- 2SD>.
Time Frame
Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Secondary Outcome Measure Information:
Title
Change of the prevalence of intestinal worm infestation among primary school children
Description
Evaluate by health assessment and laboratory test for helminth ova and the parasite
Time Frame
Baseline and 12th month after baseline (Endline)
Title
Change of the children's eating and drinking behavior, and health-related hygiene behavior
Description
Evaluate by using a questionnaire which is developed by the researcher
Time Frame
Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Title
Change of the awareness and knowledge regarding malnutrition and intestinal worm infestation
Description
Evaluate by using a questionnaire which is developed by the researcher
Time Frame
Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Title
Change of the frequency and number of school absent days among the children
Description
Evaluate by using a questionnaire which is developed by the researcher
Time Frame
Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Title
Measuring the changes of Health-related quality of life (HRQoL) of the children
Description
Evaluate by using KIDSCREEN survey form, parents' version
Time Frame
Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The primary school children who are studying in class 1 to class 5 among male, female or others gender. The children's parents or legal guardians would like to give consent and are willing to participate in the study. Those, who will be agreed to receive health check-ups, answer questionnaires and are willing to give the sample for laboratory investigation. Who will stay in the same school and area till study completion. Exclusion Criteria: The child is absent from school during the health checkup periods (at baseline) due to severe illness or without any reason and information. Who does not want to give consent and is not willing to participate. Who does not want to share their information and does not want to give the sample for laboratory investigations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadia Aivey
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
North South University
City
Dhaka
ZIP/Postal Code
1229
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
When the data will be available and we will share the data according to the recommendations of the clinical trial registration and the requests of the journals.

Learn more about this trial

Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses

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