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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465771
• Other study ID #: 9763
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2024
• Source: Aga Khan University
• Contact: Sabahat Naz
• Phone: 03362293099
• Email: sabahat.naz1[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Diabetes Mellitus
• Lung Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Royal Society of Tropical Medicine and Hygiene (RSTMH) funded by NIHR

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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