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Clinical Trials/NCT05012592
NCT05012592
Completed
Not Applicable

Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children

Hiroshima University1 site in 1 country604 target enrollmentStarted: September 17, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
604
Locations
1
Primary Endpoint
Changes in malnutrition rate among primary school children

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Changes in malnutrition rate among primary school children

Time Frame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)

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 Outcomes

  • Change of the prevalence of intestinal worm infestation among primary school children(Baseline and 12th month after baseline (Endline))
  • Change of the frequency and number of school absent days among the children(Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline))
  • Change of the children's eating and drinking behavior, and health-related hygiene behavior(Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline))
  • Change of the awareness and knowledge regarding malnutrition and intestinal worm infestation(Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline))
  • Measuring the changes of Health-related quality of life (HRQoL) of the children(Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sadia Aivey

Principal Investigator

Hiroshima University

Study Sites (1)

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