Feasibility of a Youth-led NCD Risk Reduction Initiative in Selected Schools of Slums in Karachi, Pakistan: a Mixed-methods, pre-and Post-intervention Study

The study will occur in ten selected schools within Azam Basti and Mehmoodabad, organized into five sequential phases. Phase I involves identifying NCD modifiable risk factors among younger peers (Classes 5 and 6 students) using structured diaries. Phase II includes qualitative interviews with youth (Classes 9 and 10 students), parents, and stakeholders to discuss intervention material and delivery. Phase III comprises a one-day workshop to co-create an intervention. Phase IV involves three-day training for youth to understand and deliver the intervention to their peers. Finally, Phase V assesses the intervention's feasibility using a pre-and post-test design approach.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Lung Diseases; Diabetes Mellitus; Cancer
• Intervention / Treatment: Behavioral: Youth-led NCD risk reduction intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabahat Naz; Phone Number: 03362293099; Email: sabahat.naz1@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Both government and private schools
2. Schools that have classes 1 to 10 in one boundary
3. Schools who agree to take part in the qualitative interviews
4. Schools that permit to engage youth, their parents, and younger peers in the study for ten months
5. For youth: Students of classes 9 and 10 (aged 14 to 16 years)
6. For younger peers: Students of classes 5 and 6 (9 to 12 years)
7. Students who provide written informed assent followed by parental consent
8. Parents of youth and other stakeholders, including head teachers, schoolteachers, and canteen staff who provide written informed consent

Exclusion Criteria:

1. Schools currently enrolled in any NCD-related intervention program or any similar program during the last six months
2. For youth: Having any severe or chronic medical condition or disability that restricts active participation of students in the intervention co-creation and delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Youth-led NCD risk reduction initiative; Students of grades 5 and 6 will receive NCD risk reduction intervention from youth (students of grades 9 and 10). The shared risk factors will include unhealthy diet, physical activity, and tobacco use. The NCDs will cover diabetes, cardiovascular disease, hypertension, and cancers.

Behavioral: Youth-led NCD risk reduction intervention; With the help of Youth (students of grades 9 and 10), their parents and other stakeholders, including teachers, headteachers, and canteen staff through qualitative interviews, we will develop an intervention focuses on NCD risk reduction among younger peers (students of grades 5 and 6). A nutritionist will train the youth on how to deliver the intervention among their younger peers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The compliance of delivering the intervention in schools using a fidelity checklist	Once the intervention will be finalized, a fidelity checklist will be developed and used to assess adherence to the intervention delivery. It will be reported as if the intervention is delivered completely, partially, or incomplete based on each component of the intervention	Three months
The recruitment and attrition rates for schools and children	The recruitment and attrition rates will be assessed by reporting the frequencies and percentages of schools and children (youth and younger peer) enrolled and retained in the study.	Ten months
The rate for completing the structured diaries for diet, physical activity, and tobacco use at pre-and post-intervention assessments	The frequencies and percentages of children completing the structured diaries for diet, physical activity, and tobacco use at pre-and post-intervention assessments will be reported.	Ten months
The change in the frequency and percentages of risk factors, including unhealthy diet, physical inactivity, and tobacco use at post-intervention compared to the baseline using a structured diary	The change in the frequency and percentages of risk factors, including unhealthy diet, physical inactivity, and tobacco use at post-intervention compared to the baseline will be reported. The information will be collected through structured diaries at baseline and after the intervention is delivered. The students will complete the diary for four days before and after the intervention.	Ten months

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: Royal Society of Tropical Medicine and Hygiene (RSTMH) funded by NIHR

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Estimated): June 19, 2024

Study Record Updates

• Last Update Posted (Estimated): June 19, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Cardiovascular Diseases; Lung Diseases
• Other Study ID Numbers: 9763

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No