Clinical trial NCT05012592: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Intestinal Worms
Keywords: Malnutrition
Intestinal worm infestation
School nurse
Primary school children
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: North South University
First posted: 2021-08-19
Enrollment: 604
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Changes in malnutrition rate among primary school children
timeFrame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Secondary outcomes:
measure: Change of the prevalence of intestinal worm infestation among primary school children
timeFrame: Baseline and 12th month after baseline (Endline)
measure: Change of the children's eating and drinking behavior, and health-related hygiene behavior
timeFrame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
measure: Change of the awareness and knowledge regarding malnutrition and intestinal worm infestation
timeFrame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
measure: Change of the frequency and number of school absent days among the children
timeFrame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
measure: Measuring the changes of Health-related quality of life (HRQoL) of the children
timeFrame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: North South University
Study officials:
affiliation: Hiroshima University
name: Sadia Aivey
role: PRINCIPAL_INVESTIGATOR
References: