Clinical trial NCT06009198: Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
Official title: Nutritional, Water, Sanitation and Hygiene Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan: A School Based Study: Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Adolescents
Nutrition
School
Body Mass Index
WASH
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 635
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Students leave the school during study • Consent not given by the mother/immediate care taker will be excluded from the analysis

Primary outcomes:
measure: Knowledge regarding nutrition and WASH
timeFrame: 16 weeks
measure: Attitude regarding nutrition and WASH
timeFrame: 16 weeks
measure: Practices regarding nutrition and WASH
timeFrame: 16 weeks
Secondary outcomes:
measure: Body Mass Index
timeFrame: 16 weeks
Other outcomes:
measure: Changes in Symptoms of malnutrition and micronutrient status
timeFrame: 16 weeks
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University karachi,pakistan
state: Sind
Study officials:
affiliation: Aga Khan University school of Nursing and Midwifery karachi,pakistan
name: Rozina Karmaliani, Dr
role: PRINCIPAL_INVESTIGATOR
References: