Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000625471
Ethics application status
Approved
Date submitted
3/02/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Risk factors of Non-communicable Diseases Intervention among Middle School Adolescent Children.
Scientific title
Effectiveness of School-based Interventions on Risk Factors of Non-communicable Diseases in Middle School Children of Lekhnath and Shuklagandaki Municipalities: A Quasi-Experimental Study
Secondary ID [1] 313859 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Communicable Diseases (NCDs) Prevention 336520 0
Obesity and Overweight 336521 0
Physical Inactivity 336522 0
Unhealthy Diet (Low Fruit and Vegetable Consumption) 336523 0
Condition category
Condition code
Public Health 333028 333028 0 0
Health promotion/education
Diet and Nutrition 333027 333027 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Objective:
To improve students’ knowledge, attitudes, and behaviors related to key risk factors of NCDs, such as physical inactivity, unhealthy diet, and tobacco/alcohol use.
Study Design:
A school-based intervention implemented in two phases, targeting middle school children. Schools for intervention and control were purposively selected. The program was evaluated using pre- and post-assessments.
Intervention Components
1. Mini-Lecture Sessions (Health Education Sessions)
Topics Covered:
- Importance of physical activity
- Healthy eating (especially fruit and vegetable consumption)
- Risks of tobacco and alcohol use
- Sharing health messages with parents
Session Details:
- First Phase (May 10–21, 2017):
- Two one-hour sessions (1st on fruit/vegetable consumption, 2nd on sports/physical activities)
Second Phase (May 16–21, 2018):
- One one-hour follow-up session on both topics
- Delivered by trained public health graduates and researchers
- Participation organized with prior notice; school attendance register used for tracking
2. Educational Leaflet Distribution
- Take-home leaflet developed specifically for this study
- Included key messages on healthy eating and physical activity
- Aimed at students and their parents
- Distributed during both intervention phases
3. Physical Activity Promotion
- Organized one-time sports activities (e.g., football, badminton)
- Encouraged peer involvement in games
- Delivered by trained research team members
- Student participation monitored by school principal and physical activity teacher
- A follow-up session conducted in the second phase
4. Wall Posters and Charts
- Motivational posters displayed in schools
- Reinforced messages on physical activity and healthy eating
5. Parental and Peer Engagement
- Parents informed via leaflets taken home by students
- Encouraged peer participation in physical activities
- No formal training was provided to parents or peers
- Monthly meetings held with school principals and physical activity teachers to sustain student engagement
Intervention Timeline
First Phase (May 10–21, 2017):
- Three health education sessions
- Displayed wall charts
- Distributed educational leaflets
- Provided sports materials for physical activity promotion
Second Phase (May 16–21, 2018):
- One follow-up health education session
- Redistributed the same educational leaflet

All intervention sessions and activities were conducted by trained public health graduates and researchers.
Intervention code [1] 330447 0
Behaviour
Intervention code [2] 330445 0
Prevention
Intervention code [3] 330446 0
Lifestyle
Comparator / control treatment
The study used a comparator/control group consisting of students from five selected schools (Control Schools) in Shuklagandaki Municipality.
Control Group Details:
- Intervention: No structured health promotion program was provided. Students continued with their regular school curriculum without additional health education on NCD risk factors.
- Duration: Same as the intervention group (baseline, 1-year follow-up, and 20-month follow-up).
- Mode of Administration: Students in the control schools did not receive the mini-lectures, educational materials, physical activity promotion, or motivational wall posters implemented in the intervention schools.
- Purpose: To compare changes in NCD risk factors between intervention and control groups, evaluating the effectiveness of the school-based intervention.
Control group
Active

Outcomes
Primary outcome [1] 340572 0
- Change in fruit and vegetable consumption. - Fruit and vegetables will be assessed as a composite primary outcome.
Timepoint [1] 340572 0
Three time points: - Baseline - 12-month follow-up (primary timepoint) , - 20-month follow-up
Primary outcome [2] 340571 0
- Change in mean MET
Timepoint [2] 340571 0
Three time points: - Baseline - 12-month follow-up (primary timepoint) - 20-month follow-up
Primary outcome [3] 340573 0
1. - Change in mean BMI.
Timepoint [3] 340573 0
Three time points: - Baseline - 12-month follow-up (primary timepoint) - 20-month follow-up
Secondary outcome [1] 444486 0
Types of fruits and vegetables in kitchen garden
Timepoint [1] 444486 0
Three time points: - Baseline - 12-month follow-up - 20-month follow-up
Secondary outcome [2] 446508 0
Change in mean body fat percent. This is primary outcome.
Timepoint [2] 446508 0
Three time points: - Baseline - 12-month follow-up (primary timepoint) - 20-month follow-up
Secondary outcome [3] 444484 0
Purchase of Fruits and vegetables in last week
Timepoint [3] 444484 0
Three time points: - Baseline - 12-month follow-up - 20-month follow-up
Secondary outcome [4] 446510 0
Perceived price of fruits and vegetables in school’s canteen
Timepoint [4] 446510 0
Three time points: - Baseline - 12-month follow-up - 20-month follow-up
Secondary outcome [5] 444485 0
Packaged food consumed in last week
Timepoint [5] 444485 0
Three time points: - Baseline - 12-month follow-up - 20-month follow-up
Secondary outcome [6] 446509 0
Availability of kitchen garden at home
Timepoint [6] 446509 0
Three time points: - Baseline - 12-month follow-up - 20-month follow-up

Eligibility
Key inclusion criteria
-Students aged 10-16 years enrolled in the selected schools in Lekhnath or Shuklagandaki Municipalities.
-Willingness to engage in the intervention, complete surveys, and attend follow-up assessments.
- Enrolled and registered in school.
Minimum age
10 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Students with severe health conditions that prevent participation in physical activities or assessments.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/04/2017
Date of last participant enrolment
Anticipated
Actual
5/05/2017
Date of last data collection
Anticipated
Actual
8/01/2019
Sample size
Target
418
Accrual to date
Final
423
Recruitment outside Australia
Country [1] 26856 0
Nepal
State/province [1] 26856 0
Gandaki

Funding & Sponsors
Funding source category [1] 318325 0
Government body
Name [1] 318325 0
University Grants Commission, Bhaktapur, Nepal
Country [1] 318325 0
Nepal
Primary sponsor type
Government body
Name
University Grants Commission, Bhaktapur, Nepal
Address
Country
Nepal
Secondary sponsor category [1] 321413 0
None
Name [1] 321413 0
Address [1] 321413 0
Country [1] 321413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316960 0
Pokhara University Institutional Review Committee
Ethics committee address [1] 316960 0
Ethics committee country [1] 316960 0
Nepal
Date submitted for ethics approval [1] 316960 0
02/01/2017
Approval date [1] 316960 0
16/04/2017
Ethics approval number [1] 316960 0
123/073/024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139574 0
Mr Chiranjivi Adhikari
Address 139574 0
Pokhara University, Pokhara-30, Kaski, Nepal
Country 139574 0
Nepal
Phone 139574 0
+977 9848432748
Fax 139574 0
Email 139574 0
[email protected]
Contact person for public queries
Name 139575 0
Chiranjivi Adhikari
Address 139575 0
Pokhara University, Pokhara-30, Kaski, Nepal
Country 139575 0
Nepal
Phone 139575 0
+977 9848432748
Fax 139575 0
Email 139575 0
[email protected]
Contact person for scientific queries
Name 139576 0
Chiranjivi Adhikari
Address 139576 0
Pokhara University, Pokhara-30, Kaski, Nepal
Country 139576 0
Nepal
Phone 139576 0
+977 9848432748
Fax 139576 0
Email 139576 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The data will be available to researchers, academic institutions, and public health organizations, with appropriate ethical approval and data protection measures.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Demographic information, health behaviors, physical measurements, and survey responses, will be shared in accordance with ethical guidelines.

What types of analyses could be done with individual participant data?
• The data will be available for analyses on intervention effectiveness, health behavior changes, health outcomes, and comparative studies between intervention and control groups.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: The data can be obtained from the journal supplementary materials, after publication. Target journal is not fixed.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.