NCT06009198

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
635

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

September 16, 2022

Last Update Submit

August 22, 2023

Conditions

Keywords

AdolescentsNutritionSchoolBody Mass IndexWASH

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    16 weeks

Secondary Outcomes (1)

  • Body Mass Index

    16 weeks

Other Outcomes (1)

  • Changes in Symptoms of malnutrition and micronutrient status

    16 weeks

Study Arms (2)

Advance Education with Iron Folate Supplement

EXPERIMENTAL

1. Nutrition education 2. WASH education 3. Micronutrient supplementation

Drug: Iron folate tablets

Routine Education

NO INTERVENTION

Routine school education

Interventions

Iron folate tablets will be administered to the underweight school going adolescents girls and boys to see the affect on BMI and micronutrients

Also known as: Nutrition and WASH education
Advance Education with Iron Folate Supplement

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University karachi,pakistan

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Rozina Karmaliani, Dr

    Aga Khan University school of Nursing and Midwifery karachi,pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 16, 2022

First Posted

August 24, 2023

Study Start

September 30, 2021

Primary Completion

March 15, 2022

Study Completion

May 30, 2022

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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

Locations