NCT05012592

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

September 17, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

August 11, 2021

Last Update Submit

March 2, 2023

Conditions

Keywords

MalnutritionIntestinal worm infestationSchool nursePrimary school children

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change of the prevalence of intestinal worm infestation among primary school children

    Baseline 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)

  • 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)

  • 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)

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

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

Comparison group

NO INTERVENTION

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North South University

Dhaka, 1229, Bangladesh

Location

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Sadia Aivey

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 19, 2021

Study Start

September 17, 2021

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

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.

Locations