MalnutritionNCT06009198
Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
A study testing Iron folate tablets in people with Malnutrition, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Globally, one of the major risk factor for adolescent's morbidity is considered Malnutrition. Worldwide adolescent age group 10-19 is increasing and they are at increased risk of malnutrition related diseases resulting in high morbidity and mortality. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Iron folate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Sep 2021to 30 May 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All students studying in 6, 7, and 8 grade
- Informed consent given by adolescent's mothers/immediate care takers
- Assent given by the adolescent at baseline
Who cannot join
- Students leave the school during study • Consent not given by the mother/immediate care taker will be excluded from the analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional, Water, Sanitation and Hygiene Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan: A School Based Study: Protocol
Globally, one of the major risk factor for adolescent's morbidity is considered Malnutrition. Worldwide adolescent age group 10-19 is increasing and they are at increased risk of malnutrition related diseases resulting in high morbidity and mortality. Asian countries are suffering with the double burden of malnutrition including Pakistan. The risk factors that contribute to malnutrition in the population includes unsafe drinking water, poor sanitary conditions, lack of proper waste disposal facilities, poor health awareness, poor nutrition and hygiene. However, studies have shown that nutrition education, and water, sanitation, hygiene (WASH) programmes in the schools are effective strategies to promote the health status of the adolescents (girls and boys). The primary objective of this study is to determine a school based nutrition and WASH education intervention to improve nutritional status among early adolescents.
Read the detailed description
This study is a Cluster Randomized Control Trial. Two stage sampling technique will be done. The sample size was calculated by using PASS software. Sample sizes was estimated to change in nutritional status of the early adolescent boys and girls. Sample size of 360 adolescents (180 in each intervention and control group) will achieve 80% power assuming 42% malnutrition among students in control arm and at least 6% reduction in the intervention arm having 90 students from each school at a two-sided 5% level of significance.
To assess the micronutrient levels (Iron, Zinc, Calcium, Complete Blood Count ) through blood sample, a subset of 108 adolescents 6-8 grade school going adolescents (54 intervention group,54 control group) from this total sample size (360) will be selected through random selection.
Data will be collected through adopted and adapted self-administered, structured questionnaire from 6,7, and 8 grade school going adolescents at base line and at end line.
To approach to 6, 7, and 8 grade adolescents, informed consent will be first taken from their mothers/immediate caretaker and school management. Before collecting the data, a written informed assent will also be taken from the participants available in Urdu and . Study participants will be briefed about purpose of the study and assured about anonymity and confidentiality of information shared. Finally, the survey questionnaire will be completed . In case, participants have any queries related to the questionnaire, explanation will be provided to them. Physical assessment will be done by the principal investigator which will take almost 10 minutes/ individual. For the biochemical markers assistance from local Aga Khan Laboratory will be sought. Phlebotomist /lab assistance from Aga Khan laboratory will go to the concerned educational institute and draw blood samples from the participants who have given their consent for the test.
Data analysis plan Quantitative variables will be described by means and standard deviations whereas median with interquartile range will be mentioned for qualitative variables. Frequencies and percentages will be calculated for knowledge, attitude and practices of adolescents regarding nutrition and WASH. The comparison between intervention and control at base line and end line will be performed by using paired t-test and Chi-square. For the variables that are not normally distributed, nonparametric test McNamara will be used. Binary logistic regression and multiple linear regression will be used to assess the effect of intervention. All the statistical analysis will be conducted using SPSS version 23. P value less than 0.05 will be considered statistically significant.
Intervention will be planned on the basis of socio ecological model and health promoting school framework. School health environment, health education, health services and nutrition programs will be focused in the intervention stage of the study .
Sixteen sessions (one session per week) will be arranged on nutrition education and water, sanitation, and hygiene for adolescents. Micronutrient tablets will be administered to the adolescents for three months on daily basis through school teachers. In addition, Cooking recipe in local language will be shared with adolescent's mother/immediate care takers through adolescents.
During the intervention phase, there is no such risks involve to the study participants except their valuable time. Due to micronutrient supplementation there may be temporary dizziness,nausea,headache, constipation, and dark color stool along with discomfort from prick for blood drawing from adolescents. To reduce the temporary side effects of administration of micronutrients , researcher will advise them to keep adequately hydrated themselves and take the micronutrients supplementation tablet during meal. Reassurance regarding drawing the blood samples will be done. Existing referral system will be identified and utilized if needed Study Approval will be obtained from the Aga khan University Ethical Review Committee (ERC). Approval will also be sort from the participating school management in Gojra. Any identification information like name and personnel information will be replaced by codes to address anonymity issue. Confidentiality of the data will be ensured by keeping the data under safe custody, electronic files will also be password protected. Only the primary investigator will access the raw data and the research team members involved in data analysis. Respect for human dignity will be safeguarded by completely informing the participants about all aspects of the study including purpose, their rights including right to withdraw from the study at any point, and all possible risks and benefits. This information will be communicated verbally as well as in writing in the form of consent /assent. For the adolescent's participation, assent will be obtained after taking permission from their parents / immediate caretaker.
Trial will be conducted in compliance with the protocol, Good Clinical Practice and the applicable regulatory requirement(s).
- Conditions
- Malnutrition
- Being tested
- Iron folate tablets
- Keywords
- Adolescents, Nutrition, School, Body Mass Index, WASH
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron folate tabletsDrug
Also called Nutrition and WASH education
Iron folate tablets will be administered to the underweight school going adolescents girls and boys to see the affect on BMI and micronutrients
| Study group | Role | What they receive |
|---|---|---|
| Advance Education with Iron Folate Supplement | Experimental | 1. Nutrition education
2. WASH education
3. Micronutrient supplementation Receives: Drug: Iron folate tablets |
| Routine Education | No intervention | Routine school education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge regarding nutrition and WASH
knowledge of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. It is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm
The knowledge part comprises 16 questions, each question with multiple options to assess the knowledge regarding food items, their consumption, and their effect on the health of adolescents. The knowledge will be assessed before and after intervention for comparison.
Measured: 16 weeks
Attitude regarding nutrition and WASH
Attitude of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related knowledge, attitudes and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The attitude part covers 5 questions to know the perceived benefits and perceived barriers regarding food consumption before and after the intervention
Measured: 16 weeks
Practices regarding nutrition and WASH
Practices of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and Practices (2014), also called the KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The practices part contains 11 questions that address the practices regarding the consumption of food and behaviors. Pre and Post-intervention assessment of practices will evaluate the efficacy of the education sessions.
Measured: 16 weeks
Secondary outcomes (1)
Body Mass Index
According to the Centre for Disease Control, guidelines will be followed to calculate Body Mass Index. Initially, the height and weight of all participants will be measured. the BMI will be calculated on the age parameter. This will help in determining a person's health on the basis of being Underweight, normal, Overweight, and obese. The criteria are as follow:
BMI Categories:
Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9 Obesity = BMI of 30 or greater
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start30 Sep 2021
- Primary completion15 Mar 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rozina Karmaliani, Aga Khan University
- Investigators
- Rozina Karmaliani, Dr, Principal investigator, Aga Khan University school of Nursing and Midwifery karachi,pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009198
- Sponsor's protocol ID
- : 2021-3572-19378
- Status last verified
- Aug 2023
- First submitted
- 16 Sep 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is shared on the whole through publication. The individual data will not be shared with any researcher The study findings will also shared with stake holders
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional, Water, Sanitation and Hygiene Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan: A School Based Study: Protocol
- ClinicalTrials.gov ID
- NCT06009198
- Acronym / sponsor ID
- : 2021-3572-19378
- Conditions
- Malnutrition
- Keywords
- Adolescents, Nutrition, School, Body Mass Index, WASH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 24 Aug 2023 (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.
Globally, one of the major risk factor for adolescent's morbidity is considered Malnutrition. Worldwide adolescent age group 10-19 is increasing and they are at increased risk of malnutrition related diseases resulting in high morbidity and mortality. Asian countries are suffering with the double burden of malnutrition including Pakistan. The risk factors that contribute to malnutrition in the population includes unsafe drinking water, poor sanitary conditions, lack of proper waste disposal facilities, poor health awareness, poor nutrition and hygiene. However, studies have shown that nutrition education, and water, sanitation, hygiene (WASH) programmes in the schools are effective strategies to promote the health status of the adolescents (girls and boys). The primary objective of this study is to determine a school based nutrition and WASH education intervention to improve nutritional status among early adolescents.
Detailed description
This study is a Cluster Randomized Control Trial. Two stage sampling technique will be done. The sample size was calculated by using PASS software. Sample sizes was estimated to change in nutritional status of the early adolescent boys and girls. Sample size of 360 adolescents (180 in each intervention and control group) will achieve 80% power assuming 42% malnutrition among students in control arm and at least 6% reduction in the intervention arm having 90 students from each school at a two-sided 5% level of significance.
To assess the micronutrient levels (Iron, Zinc, Calcium, Complete Blood Count ) through blood sample, a subset of 108 adolescents 6-8 grade school going adolescents (54 intervention group,54 control group) from this total sample size (360) will be selected through random selection.
Data will be collected through adopted and adapted self-administered, structured questionnaire from 6,7, and 8 grade school going adolescents at base line and at end line.
To approach to 6, 7, and 8 grade adolescents, informed consent will be first taken from their mothers/immediate caretaker and school management. Before collecting the data, a written informed assent will also be taken from the participants available in Urdu and . Study participants will be briefed about purpose of the study and assured about anonymity and confidentiality of information shared. Finally, the survey questionnaire will be completed . In case, participants have any queries related to the questionnaire, explanation will be provided to them. Physical assessment will be done by the principal investigator which will take almost 10 minutes/ individual. For the biochemical markers assistance from local Aga Khan Laboratory will be sought. Phlebotomist /lab assistance from Aga Khan laboratory will go to the concerned educational institute and draw blood samples from the participants who have given their consent for the test.
Data analysis plan Quantitative variables will be described by means and standard deviations whereas median with interquartile range will be mentioned for qualitative variables. Frequencies and percentages will be calculated for knowledge, attitude and practices of adolescents regarding nutrition and WASH. The comparison between intervention and control at base line and end line will be performed by using paired t-test and Chi-square. For the variables that are not normally distributed, nonparametric test McNamara will be used. Binary logistic regression and multiple linear regression will be used to assess the effect of intervention. All the statistical analysis will be conducted using SPSS version 23. P value less than 0.05 will be considered statistically significant.
Intervention will be planned on the basis of socio ecological model and health promoting school framework. School health environment, health education, health services and nutrition programs will be focused in the intervention stage of the study .
Sixteen sessions (one session per week) will be arranged on nutrition education and water, sanitation, and hygiene for adolescents. Micronutrient tablets will be administered to the adolescents for three months on daily basis through school teachers. In addition, Cooking recipe in local language will be shared with adolescent's mother/immediate care takers through adolescents.
During the intervention phase, there is no such risks involve to the study participants except their valuable time. Due to micronutrient supplementation there may be temporary dizziness,nausea,headache, constipation, and dark color stool along with discomfort from prick for blood drawing from adolescents. To reduce the temporary side effects of administration of micronutrients , researcher will advise them to keep adequately hydrated themselves and take the micronutrients supplementation tablet during meal. Reassurance regarding drawing the blood samples will be done. Existing referral system will be identified and utilized if needed Study Approval will be obtained from the Aga khan University Ethical Review Committee (ERC). Approval will also be sort from the participating school management in Gojra. Any identification information like name and personnel information will be replaced by codes to address anonymity issue. Confidentiality of the data will be ensured by keeping the data under safe custody, electronic files will also be password protected. Only the primary investigator will access the raw data and the research team members involved in data analysis. Respect for human dignity will be safeguarded by completely informing the participants about all aspects of the study including purpose, their rights including right to withdraw from the study at any point, and all possible risks and benefits. This information will be communicated verbally as well as in writing in the form of consent /assent. For the adolescent's participation, assent will be obtained after taking permission from their parents / immediate caretaker.
Trial will be conducted in compliance with the protocol, Good Clinical Practice and the applicable regulatory requirement(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advance Education with Iron Folate Supplement | Experimental | Drug: Iron folate tablets1. Nutrition education 2. WASH education 3. Micronutrient supplementation |
| Routine Education | No intervention | –Routine school education |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All students studying in 6, 7, and 8 grade
- Informed consent given by adolescent's mothers/immediate care takers
- Assent given by the adolescent at baseline
Key exclusion criteria (1 listed)
- Students leave the school during study • Consent not given by the mother/immediate care taker will be excluded from the analysis
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 |
|---|---|---|
| Iron folate tabletsAlso: Nutrition and WASH educationIron folate tablets will be administered to the underweight school going adolescents girls and boys to see the affect on BMI and micronutrients | Drug | Advance Education with Iron Folate Supplement |
Primary outcome
Knowledge regarding nutrition and WASH
Time frame: 16 weeks
knowledge of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. It is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The knowledge part comprises 16 questions, each question with multiple options to assess the knowledge regarding food items, their consumption, and their effect on the health of adolescents. The knowledge will be assessed before and after intervention for comparison.
Attitude regarding nutrition and WASH
Time frame: 16 weeks
Attitude of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related knowledge, attitudes and practices (2014), also called KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The attitude part covers 5 questions to know the perceived benefits and perceived barriers regarding food consumption before and after the intervention
Practices regarding nutrition and WASH
Time frame: 16 weeks
Practices of adolescents will be assessed by employing adapted tool from the FAO publication Guidelines which was developed by the Food and agriculture organization of the united nations. it is an extract from the FAO publication Guidelines for assessing nutrition-related Knowledge, attitudes, and Practices (2014), also called the KAP manual and it is available at http://www.fao.org/docrep/019/i3545e/i3545e00.htm The practices part contains 11 questions that address the practices regarding the consumption of food and behaviors. Pre and Post-intervention assessment of practices will evaluate the efficacy of the education sessions.
1 secondary outcome
Body Mass Index
Time frame: 16 weeks
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 24 Aug 2023.
- Individual participant dataSharing planned: No. The data is shared on the whole through publication. The individual data will not be shared with any researcher The study findings will also shared with stake holders
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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.
Rozina Karmaliani, Dr principal investigator
Aga Khan University school of Nursing and Midwifery karachi,pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron folate tablets in people with Malnutrition, run by Aga Khan University at 1 site in Pakistan.
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 3 inclusion and 1 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 24 Aug 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 Pakistan. 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?
Knowledge regarding nutrition and WASH (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.