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Trial registered on ANZCTR


Registration number
ACTRN12619000421134
Ethics application status
Approved
Date submitted
29/01/2019
Date registered
14/03/2019
Date last updated
12/03/2020
Date data sharing statement initially provided
14/03/2019
Date results information initially provided
12/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
School-based peer-education and peer-support for healthy lifestyles.
Scientific title
Healthier lifestyles through a peer-education and peer-support system: a school-based pilot project in adolescents in Ho Chi Minh City, Vietnam
Secondary ID [1] 297024 0
None
Universal Trial Number (UTN)
U1111-1226-4533
Trial acronym
PEPS Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent obesity 311004 0
Condition category
Condition code
Public Health 309655 309655 0 0
Health promotion/education
Diet and Nutrition 309709 309709 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The assignment of participants to the intervention or control group will be based on the location and school population size. There will be two intervention and two control schools. We will select one intervention school in the city center area and another intervention school in a sub-urban location which is far from the city center. The intervention and control schools will be matched by the school population size with one control school in city center area and another control schoolin further away from the city centre.
The intervention combines a peer-led education and a peer-led support system in total 5 months. The peer-led education part comprised three steps involving training the peer-educators (undergraduate students), peer-leaders (grade 8 students) and target grade 6 students. In the first step, two 4-hour training workshops for volunteering peer-educators (PE) are organized at Pham Ngoc Thach University of Medicine by Australian and Vietnamese expert team using a local culture-adapted material for teaching and training (PEPS manual). This PEPS manual is translated from the manual of the original SALSA program (conducted by the same Australia team) for junior high schools in New South Wales, Australia. Peer-educators also spend time to work together as teams to learn to teach and train for high school students in the next step in the following fortnight.
The second step is organized at intervened schools for peer-leaders (PL) grade 8 students by the trained PE covering the content of the PEPS manual, the approach to teaching and developing communication skills. The four 2-hour workshops which are allocated in 2 weeks will cover crucial knowledge and update of healthy active lifestyles (through 4 lessons of the PEPS manual) and communication skills for the PL to gain trust and to build strong influence to lead their adolescent peers in this behaviour changing pilot intervention. Adolescent factors and challenges will also be dealt with based on the principle of transparency, care and student’s benefit using peer groupwork. The ratio between PE and PL in training sessions is maintained as 1:5 to 1:6. During the training, the PL are grouped in working team of five to six PL with two PE in each team as supervisors. Each team is dedicated for each class of grade 6 which is the program final target (total number of teams equal to the total number of grade 6 classes). Prior to the second step, preparations for the program are made which include explaining the intervention and seeking support with project partners, including the school principal, school staff, school youth association and parental associations. All PL are selected based on their volunteer will and by the suggestion of principle teachers of grade 8 classes. All participated PL need to fulfil and sign a consent form which is also signed by parents or guardians prior to get to the next step happening in the following fortnight.
The third step is the main part of the program where teams of PL take responsibility to teach grade 6 classes the four 50-minute teaching sessions from PEPS Manual (which are Food Choices, Movement Matters, Healthy Lifestyles and PEPS Actions). Each session comprises of two main parts involving theory and practice skills. The theory part is based on specific facts and active learning which involves student participation and peer to peer interaction. Practice skills are sketched through the team or individual problem-solving games. Each session is delivered once a week by a team of 5 PL and 2 PE (as supervisors) to the class of grade 6 during their free learning hour every week (varied between schools) with the pre-agreement of all stakeholders. The four PEPS Manual sessions are delivered in four consecutive weeks which has been planned before. If any unforeseen obstacle happens and the session of the week is put on hold, the Core team members of PEPS project will discuss with school Principle and School Board to find a solution (better day to compensate for the on-hold session or extending the project to one or two weeks more). All sessions are from the PEPS Manual and additional teaching material are prepared by PE and reviewed by Expert (content author), and PE help the PL to practice and deliver the content on time. At any teaching week on any school, there are at least one Core team member of PEPS project and one reserve PE to deal with field work logistic issue and to support all teaching teams. During the last peer-education session (PEPS Actions), each class of grade 6 produce several strategies and plans and choose the best one for putting into practice in the class. The strategies and plans are based on the child health benefits, child health objectives, school environment and the will to make the behavioural changes of the children. Of those best plans of all classes, two most suitable plans will be selected to apply to the whole school after the teaching sessions finish.
The other main part of PEPS program is peer-supporting system which include a behaviour reinforcement monitoring system and social network support which will be run and led by peers (PE, PL) but also monitored by PEPS core team members. The personal reinforcement monitoring system consists of a pre-distributed personal health record diary (HRD), a classroom merit board (monthly) and school awards every semester. The class reinforcement system includes organizing school events that stimulate the participating of the class which produce activity for class members. These school events are the plans for actions at school (i.e. raising awareness of healthy lifestyle through funny health slogans, welcoming behavioural changes by adopting new action objectives…). School events also include sport fair for all grade 6 classes happening one month after the teaching sessions end. The peer-supporting online social system is introduced to children of grade 6 during the teaching sessions (step 3) which attract students to view, like and share health posts on PEPS Project Facebook public page. A working IT team with one author is taking responsibility for updating and coordinating the page to targeted schools. We will also support every school to have a student community/social platform (Facebook, Zalo, ZingVN or other networks) which will be managed by peers with teacher monitoring to share experiences and answer questions or help solve challenges given during school events. PE and PL take important role in this system as they are placed as online helpers for children to fulfil their health objectives raised in session 4 PEPS Actions. Three core team members supervised all social platforms weekly to help the PE dealing with students queries.
Intervention code [1] 313307 0
Prevention
Intervention code [2] 313340 0
Lifestyle
Intervention code [3] 313341 0
Behaviour
Comparator / control treatment
The current teacher-led physical education at school comprises of 3 sessions of 45 minutes (2 required and 1 voluntary) per week. One required session is theory-based and the other two are practical. All sessions are led by PE teachers.
The intervention differs from the current curriculum in that it utilizes peer-based system in which year 8 students delivers pieces of games of nutritional and physical activity knowledge and practices. Those games are interactive which make students more likely to move around and participate during the session.
Control group
Active

Outcomes
Primary outcome [1] 318673 0
Acceptability.
We will assess acceptability by qualitatively measuring how the intended target populations (Year 6 students, Peer Educators, Peer leaders, Teachers, and Parents) react to the intervention (peer education and peer support).
Qualitative tools, such as in-depth interviews and Focus Group Discussions with Year 6 students, Peer Educators, Peer Leaders, teachers and parents; and direct observation of schools environment and peer leaders’ interactions with the students, will be used to asses this outcome. We will use three indicators to measure: i) Satisfaction, ii) Intent to continue use, and iii) Perceived appropriateness.

Timepoint [1] 318673 0
.Evaluation at the end of the intervention (6 months after intervention).
Primary outcome [2] 319098 0
Feasibility:
Feasibility of the intervention will be assessed by qualitatively measuring the reported experience of implementing the intervention by the target populations involved in implementing the project, such as the Peer Educators, Teachers, and project staff. We will use i) In-depth interviews with teachers and project staff; and ii) Focus Group Discussions with the Peer Educators to assess the outcome. We will measure the indicators: i) Experienced barriers and facilitators of implementing the intervention, ii) Perceived barriers and facilitators to implement the intervention at a larger scale.
Timepoint [2] 319098 0
Evaluation at the end of the intervention (6 months after intervention).
Secondary outcome [1] 365646 0
Changes in dietary behaviors including skipping breakfast, consuming soft-drink and fastfood, consumption of fruits and vegetables of the targeted students (Year 6 students).
Dietary behaviors will be assessed using validated Food Frequency Questionnaire developed for usage among junior high school students which have been used in previous studies.
Timepoint [1] 365646 0
Evaluation at the end of the intervention (6 months after intervention).
Secondary outcome [2] 365670 0
Time spent for moderate to vigorous physical activity of the targeted students (Year 6 students).
Time spent for moderate to vigorous activity will be assessed using validated Physical Activity Questionnaire that have been used in previous studies among adolescents of Ho Chi Minh City.
Timepoint [2] 365670 0
Evaluation at the end of the intervention (6 months after intervention).
Secondary outcome [3] 366971 0
Time spent for sedentary behaviors of the targeted students (Year 6 students).
Time spent for sedentary behaviors will be assessed using validated Sedentary Questionnaire that have been used in previous studies among adolescents of Ho Chi Minh City
Timepoint [3] 366971 0
Evaluation at the end of the intervention (6 months after intervention).

Eligibility
Key inclusion criteria
Students would be recruited as Peer-leaders if they matched all of these criteria:
- Students at grade 8th at the included schools
- Volunteering to participate as peer-leaders (with the acceptation of parents)
- Without any major medical/health conditions which may prevent the training and teaching process

Students would be included as target children of the intervention if they are:
- Students of grade 6th at the included schools,
- Without any major medical/health issue which may prevent the communication and learning process with their peers.
Minimum age
10 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students would be excluded if they have any of the following criteria:
- They or their functioning guardian refuse to participate in the intervention.
- With medical condition(s) that physically prevent the process of communication and learning process.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21195 0
Viet Nam
State/province [1] 21195 0
Ho Chi Minh City

Funding & Sponsors
Funding source category [1] 301594 0
Government body
Name [1] 301594 0
UK Medical Research Council
Address [1] 301594 0
Head Office London - Medical Research Council
14th floor, One Kemble Street,
London, WC2B 4AN
Country [1] 301594 0
United Kingdom
Primary sponsor type
University
Name
Pham Ngoc Thach University of Medicine
Address
02 Duong Quang Trung street, Ward 12, District 10, Ho Chi Minh City, Vietnam.
(Previous address: 86/2 Thanh Thai Street, ward 12, district 10, Ho Chi Minh City, Vietnam)
Country
Viet Nam
Secondary sponsor category [1] 301297 0
University
Name [1] 301297 0
The University of Sydney - School of Public Health
Address [1] 301297 0
Edward Ford Building (A27), Fisher Road,
The University of Sydney, NSW 2006, Australia
Country [1] 301297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302322 0
Review Committee of Pham Ngoc Thach University of Medicine
Ethics committee address [1] 302322 0
02 Duong Quang Trung, Ward 12, District 10,
Ho Chi Minh City, Vietnam
(Previous address: 86/2 Thanh Thai street, Ward 12, District 10, Ho Chi Minh City, Vietnam)
Ethics committee country [1] 302322 0
Viet Nam
Date submitted for ethics approval [1] 302322 0
24/07/2017
Approval date [1] 302322 0
16/10/2017
Ethics approval number [1] 302322 0
3783/GXN-TÐHYKPNT

Summary
Brief summary
The study aims to assess feasibility and acceptability of a combined peer-led and peer-support intervention among junior high school students in Ho Chi Minh City, Vietnam. The intervention consists of four weekly education sessions of why and how to choose food & drinks healthily and also how to be more physically active. Additionally, the intervention includes a school and online support system to help maintain engagement of the students in the intervention. We will qualitatively assess the acceptability and feasibility of the intervention through interview and focus groups of the Year 6 students, who are the primary beneficiaries, and other populations involved as recipients and implementers of the intervention. We will also quantitatively assess limited efficacy by measuring changes in physical activity and dietary behaviors of the students.
Trial website
Programme social page: https://www.facebook.com/pepsproject/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89818 0
A/Prof Tang K. Hong (Hong Tang)
Address 89818 0
Office address: Faculty of Public Health
01 Duong Quang Trung Street, Ward 12, District 10,
Country 89818 0
Viet Nam
Phone 89818 0
+84903350503
Fax 89818 0
Email 89818 0
hong.tang@pnt.edu.vn
Contact person for public queries
Name 89819 0
A/Prof Tang K. Hong (Hong Tang )
Address 89819 0
Office address: Faculty of Public Health
01 Duong Quang Trung street, Ward 12, District 10,
Country 89819 0
Viet Nam
Phone 89819 0
+84903350503
Fax 89819 0
Email 89819 0
hong.tang@pnt.edu.vn
Contact person for scientific queries
Name 89820 0
Dr Ngoc-Minh Nguyen
Address 89820 0
Department of Epidemiology - Faculty of Public Health
01 Duong Quang Trung street, Ward 12, District 10,
Ho Chi Minh City, Viet Nam
Country 89820 0
Viet Nam
Phone 89820 0
+84979635835
Fax 89820 0
Email 89820 0
dr.nguyenngocminh@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
- interview and focus group data
- time spent for MVPA
- time spent for sedentary behaviors
- dietary behaviors


When will data be available (start and end dates)?
From Dec-2019 to Dec-2022
Available to whom?
Researchers, students, academics
Available for what types of analyses?
Any types of analysis
How or where can data be obtained?
We will save the data in an online repository according to the MRC data sharing policy. The data can be used with permission from the Principal Investigator and the MRC.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1062 0
Ethical approval
Citation [1] 1062 0
Link [1] 1062 0
Email [1] 1062 0
hong.tang@pnt.edu.vn
Other [1] 1062 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary