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Trial 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
NCT ID:
NCT06465771
Condition:
Diabetes Mellitus
Cardiovascular Diseases
Cancer
Lung Diseases
Conditions: Official terms:
Lung Diseases
Cardiovascular Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Youth-led NCD risk reduction intervention
Description:
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.
Arm group label:
Youth-led NCD risk reduction initiative
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
9 Years
Maximum age:
16 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
August 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Aga Khan University
Agency class:
Other
Collaborator:
Agency:
Royal Society of Tropical Medicine and Hygiene (RSTMH) funded by NIHR
Agency class:
Other
Source:
Aga Khan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465771
