Diabetes MellitusNCT06465771
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
A study testing Youth-led NCD risk reduction intervention in people with Diabetes Mellitus and Cardiovascular Diseases, run by Aga Khan University.
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. Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases, Cancer
- What is being tested?
- Youth-led NCD risk reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Both government and private schools
- Schools that have classes 1 to 10 in one boundary
- Schools who agree to take part in the qualitative interviews
- Schools that permit to engage youth, their parents, and younger peers in the study for ten months
- For youth: Students of classes 9 and 10 (aged 14 to 16 years)
- For younger peers: Students of classes 5 and 6 (9 to 12 years)
- Students who provide written informed assent followed by parental consent
- Parents of youth and other stakeholders, including head teachers, schoolteachers, and canteen staff who provide written informed consent
Who cannot join
- Schools currently enrolled in any NCD-related intervention program or any similar program during the last six months
- For youth: Having any severe or chronic medical condition or disability that restricts active participation of students in the intervention co-creation and delivery
Trial locations and contacts
No sites are listed yet.
About this 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.
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases, Cancer, Lung Diseases
- Being tested
- Youth-led NCD risk reduction intervention
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth-led NCD risk reduction interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Youth-led NCD risk reduction initiative | Experimental | 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. Receives: Behavioral: Youth-led NCD risk reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study startAug 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Society of Tropical Medicine and Hygiene
- Responsible party
- Principal investigator, Sabahat Naz, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465771
- Sponsor's protocol ID
- 9763
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naz S, Ilyas M, Iqbal R. Feasibility of co-creating and delivering a youth-led noncommunicable diseases risk reduction intervention in schools of slums in Karachi, Pakistan: protocol for a mixed-methods, pre- and post-intervention study. Pilot Feasibility Stud. 2025 Jun 2;11(1):76. doi: 10.1186/s40814-025-01662-0.
PubMed 40457417
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06465771
- Acronym / sponsor ID
- 9763
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases, Cancer, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Royal Society of Tropical Medicine and Hygiene
- Study start
- Aug 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Youth-led NCD risk reduction initiative | Experimental | Behavioral: Youth-led NCD risk reduction interventionStudents 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. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Both government and private schools
- Schools that have classes 1 to 10 in one boundary
- Schools who agree to take part in the qualitative interviews
- Schools that permit to engage youth, their parents, and younger peers in the study for ten months
- For youth: Students of classes 9 and 10 (aged 14 to 16 years)
Key exclusion criteria (2 listed)
- Schools currently enrolled in any NCD-related intervention program or any similar program during the last six months
- For youth: Having any severe or chronic medical condition or disability that restricts active participation of students in the intervention co-creation and delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth-led NCD risk reduction interventionWith 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. | Behavioural | Youth-led NCD risk reduction initiative |
Primary outcome
The compliance of delivering the intervention in schools using a fidelity checklist
Time frame: Three months
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
The recruitment and attrition rates for schools and children
Time frame: Ten months
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.
The rate for completing the structured diaries for diet, physical activity, and tobacco use at pre-and post-intervention assessments
Time frame: Ten months
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.
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
Time frame: 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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Derived from this study: PubMed 40457417Naz S, Ilyas M, Iqbal R. Feasibility of co-creating and delivering a youth-led noncommunicable diseases risk reduction intervention in schools of slums in Karachi, Pakistan: protocol for a mixed-methods, pre- and post-intervention study. Pilot Feasibility Stud. 2025 Jun 2;11(1):76. doi: 10.1186/s40814-025-01662-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Youth-led NCD risk reduction intervention in people with Diabetes Mellitus and Cardiovascular Diseases, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabahat Naz (03362293099, sabahat.naz1@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The compliance of delivering the intervention in schools using a fidelity checklist (time frame: Three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06465771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.