Malnutrition, ChildNCT05012592
Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses
A study testing Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children in people with Malnutrition, Child and Intestinal Worms, run by Hiroshima University at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child, Intestinal Worms
- What is being tested?
- Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children
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.
Read more
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.
- Conditions
- Malnutrition, Child, Intestinal Worms
- Being tested
- Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children
- Keywords
- Malnutrition, Intestinal worm infestation, School nurse, Primary school children
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School childrenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Health assessment (health checkup) and health awareness program to reduce malnutrition and helminth infestation among primary school children Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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>.
Measured: 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
Evaluate by health assessment and laboratory test for helminth ova and the parasite
Measured: Baseline and 12th month after baseline (Endline)
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
Measured: 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
Evaluate by using a questionnaire which is developed by the researcher
Measured: 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
Evaluate by using a questionnaire which is developed by the researcher
Measured: 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
Evaluate by using KIDSCREEN survey form, parents' version
Measured: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start17 Sep 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- North South University
- Responsible party
- Principal investigator, Sadia Aivey, Hiroshima University
- Investigators
- Sadia Aivey, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012592
- Sponsor's protocol ID
- 2021/OR-NSU/IRB/0701
- Other IDs
- 21H03250
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Sadia Alam A, Moshiur RM, Ashir A, Hossain HMD, Michiko M. Assessing the Impact of Health Education on Physical Measurements of Children in Bangladesh: A Non-Randomized Controlled Trial. Inquiry. 2025 Jan-Dec;62:469580251382037. doi: 10.1177/00469580251382037. Epub 2025 Oct 16.
PubMed 41098117
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children
- ClinicalTrials.gov ID
- NCT05012592
- Acronym / sponsor ID
- 2021/OR-NSU/IRB/0701
- Conditions
- Malnutrition, Child, Intestinal Worms
- Keywords
- Malnutrition, Intestinal worm infestation, School nurse, Primary school children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- North South University
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Behavioral: Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School childrenHealth assessment (health checkup) and 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 |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School childrenThis 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. | Behavioural | Intervention Group |
Primary outcome
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>.
5 secondary outcomes
Change of the prevalence of intestinal worm infestation among primary school children
Time frame: Baseline and 12th month after baseline (Endline)
Change of the children's eating and drinking behavior, and health-related hygiene behavior
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 41098117Sadia Alam A, Moshiur RM, Ashir A, Hossain HMD, Michiko M. Assessing the Impact of Health Education on Physical Measurements of Children in Bangladesh: A Non-Randomized Controlled Trial. Inquiry. 2025 Jan-Dec;62:469580251382037. doi: 10.1177/00469580251382037. Epub 2025 Oct 16.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadia Aivey principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children in people with Malnutrition, Child and Intestinal Worms, run by Hiroshima University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in malnutrition rate among primary school children (time frame: Baseline, 4th/ 5th month after baseline (Midline) and 12th month after baseline (Endline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05012592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.