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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06465771
Enrollment
40
Registered
2024-06-20
Start date
2024-08-31
Completion date
2025-08-31
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cardiovascular Diseases, Diabetes Mellitus, Lung Diseases

Brief 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.

Interventions

BEHAVIORALYouth-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.

Sponsors

Royal Society of Tropical Medicine and Hygiene
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The compliance of delivering the intervention in schools using a fidelity checklistThree monthsOnce 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
The recruitment and attrition rates for schools and childrenTen monthsThe 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.
The rate for completing the structured diaries for diet, physical activity, and tobacco use at pre-and post-intervention assessmentsTen monthsThe 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.
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 diaryTen monthsThe 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.

Contacts

Primary ContactSabahat Naz
sabahat.naz1@aku.edu03362293099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026