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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]

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

Condition category

Condition code

Public Health

Health promotion/education

Diet and Nutrition

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

.Evaluation at the end of the intervention (6 months after intervention).

Primary outcome [2]

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]

Evaluation at the end of the intervention (6 months after intervention).

Secondary outcome [1]

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]

Evaluation at the end of the intervention (6 months after intervention).

Secondary outcome [2]

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]

Evaluation at the end of the intervention (6 months after intervention).

Secondary outcome [3]

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]

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

Sex

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

3/09/2018

Date of last participant enrolment

Anticipated

28/03/2019

Actual

29/03/2019

Date of last data collection

Anticipated

30/09/2019

Actual

1/10/2019

Sample size

Target

360

Accrual to date

Final

317

Recruitment outside Australia

Country [1]

Viet Nam

State/province [1]

Ho Chi Minh City

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

UK Medical Research Council

Address [1]

Head Office London - Medical Research Council
14th floor, One Kemble Street,
London, WC2B 4AN

Country [1]

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]

University

Name [1]

The University of Sydney - School of Public Health

Address [1]

Edward Ford Building (A27), Fisher Road,
The University of Sydney, NSW 2006, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Review Committee of Pham Ngoc Thach University of Medicine

Ethics committee address [1]

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]

Viet Nam

Date submitted for ethics approval [1]

24/07/2017

Approval date [1]

16/10/2017

Ethics approval number [1]

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

A/Prof Tang K. Hong (Hong Tang)

Address

Office address: Faculty of Public Health
01 Duong Quang Trung Street, Ward 12, District 10,

Country

Viet Nam

Phone

+84903350503

Fax

[email protected]

Contact person for public queries

Name

A/Prof Tang K. Hong (Hong Tang )

Address

Office address: Faculty of Public Health
01 Duong Quang Trung street, Ward 12, District 10,

Country

Viet Nam

Phone

+84903350503

Fax

[email protected]

Contact person for scientific queries

Name

Dr Ngoc-Minh Nguyen

Address

Department of Epidemiology - Faculty of Public Health
01 Duong Quang Trung street, Ward 12, District 10,
Ho Chi Minh City, Viet Nam

Country

Viet Nam

Phone

+84979635835

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1062	Ethical approval			[email protected]		376690-(Uploaded-14-01-2019-23-06-19)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of a peer-led education intervention on dietary behaviour and physical activity among adolescents in Ho Chi Minh City, Vietnam: a pilot study.	2022	https://dx.doi.org/10.1038/s41430-022-01140-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically