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

Malnutrition, Child Clinical Trial

Official title:

Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012592
• Other study ID #: 2021/OR-NSU/IRB/0701
• Secondary ID: 21H03250
• Status: Completed
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Communicable Diseases
• Infections
• Intestinal Worms
• Malnutrition
• Malnutrition, Child

Intervention

Behavioral:
• Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children
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.

Locations

Country	Name	City	State
Bangladesh	North South University	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	North South University

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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>.	Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Secondary	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	Baseline and 12th month after baseline (Endline)
Secondary	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	Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Secondary	Change of the awareness and knowledge regarding malnutrition and intestinal worm infestation	Evaluate by using a questionnaire which is developed by the researcher	Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Secondary	Change of the frequency and number of school absent days among the children	Evaluate by using a questionnaire which is developed by the researcher	Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Secondary	Measuring the changes of Health-related quality of life (HRQoL) of the children	Evaluate by using KIDSCREEN survey form, parents' version	Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)