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Trial registered on ANZCTR


Registration number
ACTRN12617000712303
Ethics application status
Approved
Date submitted
12/05/2017
Date registered
17/05/2017
Date last updated
17/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of the Students As LifeStyle Activists (SALSA) project on dietary and physical activity of high school students
Scientific title
A pre-post evaluation of the Students As LifeStyle Activists (SALSA) project on dietary and physical activity behaviours of high school students in western Sydney
Secondary ID [1] 291928 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SALSA project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-communicable disease 303257 0
Condition category
Condition code
Diet and Nutrition 302677 302677 0 0
Obesity
Public Health 302678 302678 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SALSA program is a peer-led educational intervention to motivate high school students to make healthier lifestyle choices. The broad aims of the SALSA program are to promote healthy eating patterns and regular physical activity in an engaging, fun and supportive school environment. The SALSA program is incorporated into each school’s Personal Development, Health and Physical Education (PDHPE) curriculum to complement lessons taught by PDHPE teachers. The program specifically targets schools in western Sydney where the risk for overweight and obesity development is a major public health concern.
The theoretical framework of the SALSA program is based on Bandura’s Social Cognitive Theory and empowerment education approach. The Social Cognitive Theory proposes a reciprocal determinism in the interaction between a person, a targeted behaviour and a particular social context. It emphasises that people learn not only from their own experiences but also by observing the actions of others. Accordingly adolescents are encouraged to (i) observe and imitate the positive behaviours of others; (ii) see positive behaviours modelled and practised; (iii) empower and increase their own capability and confidence to implement new skills; (iv) adopt positive attitudes about implementing new skills and; (v) use their new skills in a supportive environment. The intervention strategies are based on the empowerment education approach, wherein students gain knowledge through group sharing and understanding of the social influences that affect their lives, set their own priorities and decide on group action in order to change conditions or resolve issues.
A variety of strategies including a video, games, role-playing and a quiz show are used in the program, with participation and fun central to all aspects of learning. The program materials and delivery of the four lessons by the SALSA Year 10 Peer Leaders to Year 8 students are standardised through the use of structured lessons using the Peer Leaders Manual and the ‘Ryan’s Goal’ video (available at www.sydney.edu.au/medicine/public-health/salsa-triple-a/).

Implementation of the SALSA program in 2014-15
Initially, project staff train volunteer university students from health and education disciplines as SALSA Educators. The SALSA educator training is completed in a face-to-face, one-day (~8 hour) workshop. University students are required to attend one workshop and provide a Working With Children Check clearance before visiting the high schools.
[96 university students were trained in four workshops, two in 2014 and two in 2015]
Next, the SALSA program is delivered to high schools as a three-step process involving university students, and high school students as both learners and educators. Delivery of the SALSA program is designed to be flexible and work within the school timetable. Each participating school appoints a teacher (SALSA coordinator) to coordinate the following intervention components in conjunction with SALSA program staff.
Three step process:
Step 1: Trained SALSA Educators (university students) coach volunteer or teacher selected Year 10 students as SALSA Peer Leaders for the program, during a one-day workshop. The Peer Leaders learn about nutrition and physical activity and acquire skills in group facilitation, teaching and leadership.
[32 peer leader workshops were held, with 96 university students training 869 Year 10 SALSA peer leaders across 23 high schools]
Step 2: The school SALSA coordinator allocates trained peer leaders to deliver the SALSA lessons in groups. We recommended a minimum of four students per group. Each group of peer leaders delivers the 4 x 70 minute lessons to Year 8 students using the Peer Leader’s Manual as a guide. Lesson delivery is usually completed in less than 4 weeks. Students learn about nutrition, physical activity and healthy lifestyle behaviours through videos, games and activities. The Year 8 PDHPE teacher provides general supervision and only assisted with behaviour management as needed. Schools
[869 SALSA peer leaders educated over 3,800 Year 8 students in 23 high schools]
Step 3: Wider dissemination of healthy lifestyle information occurs when students from the Year 8 classes develop a personal goal and a school-action plan in the final SALSA lesson. We expect that students implement the personal goals set as part of the SALSA program, leading to health-related behaviour change, and share their experience in the program with their friends and family. The school action plan is developed during the final SALSA lesson for students to lead in improving their school environment e.g. organise sports, start breakfast clubs, change food availability in canteens. The implementation of these action plans was not recorded in this study.

Study design
The present study adopted a pre-post evaluation design. At each school, all Year 8 classes and a select group of Year 10 students (to be trained as SALSA peer leaders) completed a 10-minute online evaluation questionnaire.

A range of process data was collected throughout the project to monitor implementation fidelity and the acceptability of the SALSA program to the target populations.
*Training workshops: At the conclusion of the training workshops, all university SALSA Educators and Year 10 Peer Leaders completed a paper-based feedback questionnaire regarding their training experience.
*Year 10 peer leader debriefing session: A second paper-based questionnaire was completed by Year 10 Peer Leaders to obtain further feedback after the four SALSA lessons had been delivered. A debrief discussion was also facilitated post-workshop and responses were scribed and recorded for analysis.
*Year 8 teachers: School PDHPE teachers were asked to complete lesson logs to monitor the SALSA program implementation in 2014 and 2015. For each of the four SALSA lessons, the date of completion, number of Peer Leaders and number of Year 8 students were recorded by the teachers, and returned to SALSA staff at the completion of the program.
*Principals and School SALSA coordinators: The Project Leader and Project Officer conducted additional informal interviews with the teachers who coordinated the SALSA programs and school principals to get their feedback on the program.
Intervention code [1] 298047 0
Behaviour
Intervention code [2] 298048 0
Lifestyle
Intervention code [3] 298049 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302083 0
The primary outcome variable of the 2014/15 SALSA program survey is the within subject change in frequency (days per week) of Year 8 students eating breakfast from pre to post SALSA intervention. Reported through an online questionnaire designed specifically for this study, based on a validated item.

Bruening M, Eisenberg M, MacLehose R, Nanney MS, Story M, Neumark-Sztainer D. Relationship between adolescents' and their friends' eating behaviors: breakfast, fruit, vegetable, whole-grain, and dairy intake. J Acad Nutr Diet. 2012
Oct;112(10):1608-13.
Timepoint [1] 302083 0
Three time points were identified for data collection:
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion ).
Secondary outcome [1] 334697 0
Usual intake of fruit (serves per day) reported through an online questionnaire designed specifically for this study, based on a validated item.

Niven P, Scully M, Morley B, Crawford D, Baur LA, Wakefield M; NaSSDA Study Team. Socio-economic disparities in Australian adolescents' eating behaviours. Public Health Nutr. 2014 Dec;17(12):2753-8.
Timepoint [1] 334697 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion ).
Secondary outcome [2] 334698 0
Usual intake of vegetables (serves per day) reported through an online questionnaire designed specifically for this study, based on a validated item.

Niven P, Scully M, Morley B, Crawford D, Baur LA, Wakefield M; NaSSDA Study Team. Socio-economic disparities in Australian adolescents' eating behaviours. Public Health Nutr. 2014 Dec;17(12):2753-8.
Timepoint [2] 334698 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion ).
Secondary outcome [3] 334699 0
Usual daily consumption of sugar sweetened beverages (e.g. soft drinks, fruit juice, cordials, sports drinks and energy drinks). Reported through an online questionnaire designed specifically for this study, based on a validated item.

Niven P, Scully M, Morley B, Crawford D, Baur LA, Wakefield M; NaSSDA Study Team. Socio-economic disparities in Australian adolescents' eating behaviours. Public Health Nutr. 2014 Dec;17(12):2753-8.
Timepoint [3] 334699 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [4] 334711 0
Frequency of being sufficiently physically active (i.e. 60 minutes or more daily). Reported through an online questionnaire designed specifically for this study, based on a validated item.

Scott JJ, Morgan PJ, Plotnikoff RC, Lubans DR. Reliability and validity of a
single-item physical activity measure for adolescents. J Paediatr Child Health.
2015 Aug;51(8):787-93.
Timepoint [4] 334711 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [5] 334712 0
Usual daily recreational screen use reported through an online questionnaire designed specifically for this study, based on a validated item.

Lubans DR, Lonsdale C, Plotnikoff RC, Smith J, Dally K, Morgan PJ. Development
and evaluation of the Motivation to Limit Screen-time Questionnaire (MLSQ) for adolescents. Prev Med. 2013 Nov;57(5):561-6.
Timepoint [5] 334712 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [6] 334880 0
Intentions to eat breakfast every day over the next month reported through an online questionnaire designed specifically for this study, based on a validated item.

Dewar DL, Lubans DR, Plotnikoff RC, Morgan PJ. Development and evaluation of social cognitive measures related to adolescent dietary behaviors. Int J Behav Nutr Phys Act. 2012 Apr 2;9:36.
Timepoint [6] 334880 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [7] 334881 0
Intentions to eat fruit over the next month reported through an online questionnaire designed specifically for this study, based on a validated item.

Dewar DL, Lubans DR, Plotnikoff RC, Morgan PJ. Development and evaluation of social cognitive measures related to adolescent dietary behaviors. Int J Behav Nutr Phys Act. 2012 Apr 2;9:36.
Timepoint [7] 334881 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [8] 334882 0
Intentions to eat vegetables over the next month reported through an online questionnaire designed specifically for this study, based on a validated item.

Dewar DL, Lubans DR, Plotnikoff RC, Morgan PJ. Development and evaluation of social cognitive measures related to adolescent dietary behaviors. Int J Behav Nutr Phys Act. 2012 Apr 2;9:36.
Timepoint [8] 334882 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [9] 334883 0
Intentions to be physically active on all or most days of the week reported through an online questionnaire designed specifically for this study, based on a validated item.

Dewar DL, Lubans DR, Plotnikoff RC, Morgan PJ. Development and evaluation of social cognitive measures related to adolescent dietary behaviors. Int J Behav Nutr Phys Act. 2012; 9:36.
Timepoint [9] 334883 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [10] 334884 0
Intentions to spend less free time sitting and doing activities involving screens (e.g. mobile phone, tablet, computer, gaming console, TV). Reported through an online questionnaire designed specifically for this study, based social cognitive theory, as in other secondary outcome measures.
Timepoint [10] 334884 0
Three time points.
pre-intervention i.e. before participation;
post-intervention (within 2 weeks after completion of the program) and;
follow-up (Term 4, approximately three-five months after program completion).
Secondary outcome [11] 334886 0
Acceptability:
*Training workshops: At the conclusion of the training workshops, all university SALSA Educators and Year 10 Peer Leaders completed a paper-based feedback questionnaire regarding their training experience.
*Year 10 peer leader debriefing session: An additional paper-based questionnaire was completed by Year 10 Peer Leaders to obtain further feedback after the four SALSA lessons had been delivered. A debrief discussion was also facilitated post-workshop and responses were scribed and recorded for analysis.
*Year 8 teachers: School PDHPE teachers were asked to complete lesson logs to monitor the SALSA program implementation in 2014 and 2015. For each of the four SALSA lessons, the date of completion, number of Peer Leaders and number of Year 8 students were recorded by the teachers, and returned to SALSA staff at the completion of the program.
*Principals and School SALSA coordinators: The Project Leader and Project Officer conducted additional informal interviews with the teachers who coordinated the SALSA programs and school principals to get their feedback on the program.
Timepoint [11] 334886 0
*University student training workshop feedback was collected on the same day as the workshop, after all activities had been completed.
*Year 8 teachers completed lesson logs on the same day as program delivery in their classroom.
*Peer leader debriefing post-intervention, within 2 weeks after completion of the program.
*Additional informal interviews with the teachers who coordinated the SALSA programs and school principals to get their feedback on the program were completed at post-intervention, within 2 weeks after completion of the program.
Secondary outcome [12] 334887 0
Fidelity
*Training workshops: At the conclusion of the training workshops, all university SALSA Educators and Year 10 Peer Leaders completed a paper-based feedback questionnaire regarding their training experience.
*Year 10 peer leader debriefing session: An additional paper-based questionnaire was completed by Year 10 Peer Leaders to obtain further feedback after the four SALSA lessons had been delivered. A debrief discussion was also facilitated post-workshop and responses were scribed and recorded for analysis.
*Year 8 teachers: School PDHPE teachers were asked to complete lesson logs to monitor the SALSA program implementation in 2014 and 2015. For each of the four SALSA lessons, the date of completion, number of Peer Leaders and number of Year 8 students were recorded by the teachers, and returned to SALSA staff at the completion of the program.
*Principals and School SALSA coordinators: The Project Leader and Project Officer conducted additional informal interviews with the teachers who coordinated the SALSA programs and school principals to get their feedback on the program.
Timepoint [12] 334887 0
*University student training workshop feedback was collected on the same day as the workshop, after all activities had been completed.
*Year 8 teachers completed lesson logs on the same day as program delivery in their classroom.
*Peer leader debriefing post-intervention, within 2 weeks after completion of the program.
*Additional informal interviews with the teachers who coordinated the SALSA programs and school principals to get their feedback on the program were completed at post-intervention, within 2 weeks after completion of the program.

Eligibility
Key inclusion criteria
All participants will be school aged children attending secondary schools (Government, Catholic and independent) in Western Sydney, New South Wales, Australia, who have accepted the SALSA program as part of the school PDHPE curriculum.
Participants will include:
*Year 8 male and female students (aged 13-14 years)
*Year 10 Peer Leaders, male and female (aged 15-16 years).
Minimum age
13 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools dedicated to educating students with special needs

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
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 in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296431 0
Government body
Name [1] 296431 0
Australian Government Department of Health, Chronic Disease Prevention and Service Improvement Fund,
Address [1] 296431 0
Department of Health
GPO Box 9848,
Canberra ACT 2601, Australia
Country [1] 296431 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
PO Box 533, Westmead NSW 2145, Australia
Country
Australia
Secondary sponsor category [1] 295384 0
University
Name [1] 295384 0
Sydney Medical School, The University of Sydney
Address [1] 295384 0
PO Box 533, Westmead NSW 2145, Australia
Country [1] 295384 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297660 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 297660 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 297660 0
Australia
Date submitted for ethics approval [1] 297660 0
12/03/2014
Approval date [1] 297660 0
23/04/2014
Ethics approval number [1] 297660 0
2014/203
Ethics committee name [2] 297662 0
State Education Reserach Application Process
Ethics committee address [2] 297662 0
School Policy and Information Management (SERAP)
NSW Department of Education
Locked Bag 53
Darlinghurst NSW 1300
Ethics committee country [2] 297662 0
Australia
Date submitted for ethics approval [2] 297662 0
04/04/2014
Approval date [2] 297662 0
08/05/2014
Ethics approval number [2] 297662 0
2014096
Ethics committee name [3] 297663 0
Catholic Education Office
Ethics committee address [3] 297663 0
12 Victoria Road
Parramatta NSW 2150
Ethics committee country [3] 297663 0
Australia
Date submitted for ethics approval [3] 297663 0
20/11/2014
Approval date [3] 297663 0
11/12/2014
Ethics approval number [3] 297663 0

Summary
Brief summary
The SALSA (Students As LifeStyle Activists) program is a school-based, peer-led initiative to improve nutritional intake and increase physical activity amongst high school students. Since 2004, the SALSA program has been provided to high schools in Western Sydney with the support of various organisations including Rooty Hill High School, Mt Druitt and Blacktown Medical Practitioner’s Associations, Primary Health Care Education and Research Unit, the University of Sydney and Western Sydney Medicare Local. The Commonwealth Department of Health has provided funding to support the implementation and evaluation of the SALSA program in high schools in 2014/15.
The SALSA program is incorporated into each school’s curriculum to complement lessons taught by teachers. The program is simply described in this brief video: https://youtu.be/jiudp1few9Q
This research aims to determine the extent in which the SALSA program influences positive changes in key dietary and physical activity behaviours, and intentions regarding these behvaiours, associated with a healthy lifestyle in Year 8 participants and Year 10 peer leaders. Key outcomes were:
* Frequency of breakfast intake, and intention to eat breakfast daily.
* Usual daily intake of fruit; and intention to eat more fruit.
* Usual daily intake of vegetables; and intention to eat more vegetables.
* Usual daily consumption of fruit juice and other sugary drinks (e.g. soft drinks, cordials, sports drinks and energy drinks).
* Frequency of being sufficiently physically active (i.e. 60 minutes or more daily); and intention to be physically active more often.
* Usual daily recreational screen use; and intention to devote less recreational time to screen activities.
We hypothesised that the SALSA program would influence positive changes in the frequency of breakfast eating and other health related behaviours in Year 8 students and Year 10 Peer Leaders.
In Year 8 students and Year 10 peer leaders, behaviours and behavioural intentions were measured before the SALSA program, 2 weeks after completing the program, and 3-5 months after completing the program. Ethical approval was granted in 2014 from the University of Sydney and the Department of Education (the University of Sydney no: 2014/203; SERAP no: 2014096). In late 2014, we also received approval from the Catholic Education Office to approach and recruit Catholic Schools in western Sydney to participate in the SALSA program evaluation. All high schools that implemented the SALSA program agreed to participate in the evaluation. As partners, they were responsible for distributing a letter to parents/caregivers of Peer Leaders and Year 8 students informing them of the school’s and their child’s invitation to participate in SALSA program. If parents did not wish for their child to participate in the program evaluation, a tear off slip was to be signed and returned to the school.
Trial website
http://sydney.edu.au/medicine/public-health/salsa-triple-a/salsa/
Trial related presentations / publications
Public notes
Ethical approval was granted in 2014 from the University of Sydney and the Department of Education (the University of Sydney no: 2014/203; SERAP no: 2014096). In late 2014, we also received approval from the Catholic Education Office to approach and recruit Catholic Schools in western Sydney to participate in the SALSA program evaluation.
All high schools that implemented the SALSA program agreed to participate in the evaluation. As partners, they were responsible for distributing a letter to parents/caregivers of Peer Leaders and Year 8 students informing them of the school’s and their child’s invitation to participate in SALSA program. If parents did not wish for their child to participate in the program evaluation, a tear off slip was to be signed and returned to the school.
Attachments [1] 1716 1716 0 0
Attachments [2] 1717 1717 0 0
Attachments [3] 1718 1718 0 0
Attachments [4] 1721 1721 0 0
/AnzctrAttachments/372920-ANZCTRSample size statement.docx (Supplementary information)
Attachments [5] 1723 1723 0 0

Contacts
Principal investigator
Name 74738 0
A/Prof Smita Shah
Address 74738 0
Primary Health Care Education and Research Unit
Research and Education Network, Western Sydney Local Health District
PO Box 533, Westmead, NSW, 2145 Australia
Country 74738 0
Australia
Phone 74738 0
+61 2 98456505
Fax 74738 0
Email 74738 0
smita.shah@health.nsw.gov.au
Contact person for public queries
Name 74739 0
A/Prof Smita Shah
Address 74739 0
Primary Health Care Education and Research Unit
Research and Education Network, Western Sydney Local Health District
PO Box 533, Westmead, NSW, 2145 Australia
Country 74739 0
Australia
Phone 74739 0
+61 2 98456505
Fax 74739 0
Email 74739 0
smita.shah@health.nsw.gov.au
Contact person for scientific queries
Name 74740 0
A/Prof Smita Shah
Address 74740 0
Primary Health Care Education and Research Unit
Research and Education Network, Western Sydney Local Health District
PO Box 533, Westmead, NSW, 2145 Australia
Country 74740 0
Australia
Phone 74740 0
+61 2 98456505
Fax 74740 0
Email 74740 0
smita.shah@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary