Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

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).
    

Intervention name(s): Iron folate tablets
Intervention type(s): Drug
Intervention description(s): Iron folate tablets will be administered to the underweight school going adolescents girls and boys to see the affect on BMI and micronutrients
Other intervention name(s): Nutrition and WASH education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Nutrition; School; Body Mass Index; WASH