Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001213336
Ethics application status
Approved
Date submitted
16/08/2017
Date registered
18/08/2017
Date last updated
20/06/2019
Date data sharing statement initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised controlled trial of a sugar-sweetened beverage intervention in secondary schools.
Scientific title
A cluster randomised controlled trial to evaluate the efficacy of a secondary school intervention in reducing sugar-sweetened beverage consumption.
Secondary ID [1] 292661 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
switchURsip
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 304401 0
Unhealthy diet 304402 0
Condition category
Condition code
Public Health 303731 303731 0 0
Health promotion/education
Diet and Nutrition 303759 303759 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schools allocated to the intervention group will implement a program to reduce sugar-sweetened beverage (SSB) consumption in students, using a whole schools approach by adopting strategies across the three arms of the Health Promoting Schools Framework. The intervention will run for two school terms from Term 2 to Term 3 2018 (one school term runs for approximately 10 weeks).

Curriculum and teaching:
Students will participate in two nutrition education lessons relating to SSB, incorporated into the schools’ Personal Development, Health and Physical Education (PDHPE) classes to be delivered by the school PDHPE teacher. Lesson plans will cover SSB sugar content awareness, adverse health effects of excessive SSB consumption, healthier drink alternatives, and semi-individualised feedback and goal setting to monitoring their own SSB consumption.

Students will receive six fortnightly notifications in the second term via the school’s electronic communication channel to students. These will provide advice on reducing their SSB consumption, healthier drink alternatives, and reminders of adverse health effects of excessive SSB consumption.

A school-based month-long challenge to encourage students to reduce SSB from their diets will be planned, led and carried out by a student committee in each school. Funding and resources will be provided by the research team on the completion of a grant application by the student committee. Strategies and activities will focus on increasing awareness and motivation, creating a presence on social media platforms, and fostering peer support to reduce SSB consumption.

Ethos and environment:
Guiding principles will be discussed with schools to fit into the school’s management plan and local procedures that contain the key messages of the intervention.

The school environment will be modified to reduce the appeal of SSB to students. Specifically:

i) Canteens and vending machines will be advised to lower the availability of SSB in the canteen by decreasing SSB options.
ii) Drinks will be classified by a dietitian as Everyday, Occasional and Should Not Be Sold as per the NSW Healthy School Canteen Strategy. SSB that are still sold in canteens will be removed from display and concealed under the counter. Placement of drinks in the vending machine will be altered so that Everyday drinks appear at the top of the vending machine around eye level, followed by Occasional, and finally Should Not Be Sold.
iii) SSB will also receive an increased price mark-up of at least 20% compared to their selling price at baseline. Occasional drinks will be encouraged to be sold at a price at least 10% above their selling price at baseline, while ensuring that all Should Not Be Sold drinks (including SSB) are more expensive than Occasional drinks, and all Occasional drinks are more expensive than Everyday drinks.
iv) Promotion of SSB will be advised not to promote SSB, and healthier drink alternatives will be promoted to students via meal deals and posters.

The goal by the end of the intervention is to remove all SSB from sale in the school as per the strategy.
Two water bottle refill stations (with flow meters for monitoring) will be placed on school grounds to encourage water consumption with the aim to displace SSB.

Partnerships and services:
Parents will receive six fortnightly notifications in the second term via the school’s electronic communication channel. Notifications will provide advice on reducing their own SSB consumption and availability in the home environment, suggestions of healthier drink alternatives and role modelling. Adverse health effects of excessive SSB consumption, and tips on how to monitor and reduce the parent’s own SSB consumption will also be included. Six notifications will be sent to parents at the same time as the notification to students, with coinciding key message themes.

A short snippet will be included in the school newsletter at the start of each school term to provide updates on the intervention. A total of two newsletter snippets will be drafted by the research team and sent to the school administration at the start of each intervention school term. Summarised results of the study will also be published in the newsletters.


Five support strategies will be used to increase adoption of the intervention components by schools. These strategies have been effective in facilitating the adoption of other school based nutrition interventions.

Executive leadership and school committees: Once a school is allocated to the intervention group, a meeting with the key stakeholders including the principal, canteen manager and school champion will be arranged to brief the school on the key intervention components such as the guidelines, canteen strategies and lesson plans. Peer-led planning and collaboration has been shown to be an effective support strategy to increase interest and adoption of the intervention in adolescent-based interventions. A teacher school champion and a student committee will be elected for each school and will serve as change agents by actively supporting and advocating the key messages of the intervention.

Audit and feedback: To assist with the changes to the canteen and vending machines, a trained dietitian experienced in reviewing school canteen menus will audit the school’s drinks menu at the start of the intervention. Feedback will be provided via written reports to intervention schools. The report will contain personalised advice on reducing the sale of SSB and a meeting will be arranged with the canteen staff to discuss the feedback and their time will be reimbursed. One further feedback report will be provided at the intervention midpoint to help canteens work towards the end goal.

Resources: Resources and promotional incentives such as lesson plans, canteen and vending machine pictograms, kitchen equipment (blender and recipe cards), water refill stations and water bottles will be provided to the schools. Other promotional material such as posters, newsletter snippets and notifications will also be prepared and sent to schools over the course of the intervention.

Staff professional learning: Secondary school staff will be informed about the intervention via a short 20-minute presentation delivered by the research team within a usual staff meeting before the commencement of the intervention. An online staff professional development session will also be offered to equip Personal Development, Health and Physical Education (PDHPE) teachers with the skills and understanding to deliver the student lesson plans and provide positive role modelling and guidance for students. The session will take approximately ten minutes to complete and will be hosted on the program website.

Communication and marketing: Research indicates that communication and marketing can increase awareness of key health messages leading to improved intervention endorsement and adoption. This will be achieved via school newsletter snippets, posters and notifications using the school’s electronic communication channel. The program will also have an attractive name (switchURsip), chosen through feedback from adolescents, for marketing and promotion on traditional and digital platforms to appeal to adolescents. A switchURsip website will be created for the school, students and parents. This website will contain all the resources under the appropriate tabs for school staff, students and parents and will be hosted on the Good for Kids. Good for Life website. This will provide easy access of intervention components for schools involved in the study. Control schools will have limited access to the website using passwords and will only be given access to the website at the end of the intervention period.
Intervention code [1] 298895 0
Prevention
Intervention code [2] 298896 0
Lifestyle
Intervention code [3] 298897 0
Behaviour
Comparator / control treatment
The control schools will continue to operate their school as standard procedure. The students will not experience any difference other than at data collection time points. Support and intervention materials will be made available to control schools following completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 303100 0
Overall daily SSB consumption (mL) collected via the Australian Children and Adolescent Eating Survey (ACAES) validated online FFQ
Timepoint [1] 303100 0
The primary outcomes will be compared between groups at baseline and post-intervention. A mid-point data collection will occur after one term of intervention.
Primary outcome [2] 303120 0
Daily percentage energy (kJ) from SSB collected via the Australian Children and Adolescent Eating Survey (ACAES) validated online FFQ
Timepoint [2] 303120 0
The primary outcomes will be compared between groups at baseline and post-intervention. A mid-point data collection will occur after one term of intervention.
Secondary outcome [1] 337889 0
Average daily SSB consumption in school collected using an online student survey appended to the ACAES using adapted questions from the ACAES relating to SSB consumption.
Timepoint [1] 337889 0
The secondary outcomes will be compared for baseline and post-intervention, with a mid-point data collection after one term of intervention.
Secondary outcome [2] 337937 0
Average daily energy intake collected via the Australian Children and Adolescent Eating Survey (ACAES) validated online FFQ
Timepoint [2] 337937 0
The secondary outcomes will be compared for baseline and post-intervention, with a mid-point data collection after one term of intervention.
Secondary outcome [3] 337938 0
Average student BMI z-scores calculated by measuring students’ weight and height using International Society for the Advancement of Kinanthropometry (ISAK) procedures. BMI status determined using the using International Obesity Taskforce definitions.
Timepoint [3] 337938 0
Student BMI will only be measured at baseline and follow-up, and these measurements will only be conducted in Year 7 students.

Eligibility
Key inclusion criteria
Independent (AIS) and Catholic (CSO) secondary schools in the Hunter New England (HNE) region will be eligible if the school is co-educational, enrols Year 7 to 9 students, has an average of 100 students or more per year for those year levels, has an onsite food outlet that sells SSB to students at baseline, and has no other current school-based physical activity or nutrition intervention. Classes catering for students with severe physical and mental disabilities (i.e. specialist support classes) will be excluded.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with severe intellectual or physical disabilities will be excluded from data collection.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A convenience sample of schools meeting the eligibility criteria will be sent a letter with an invitation to participate in this pilot study. One to two weeks following the letter, a member of the research team will contact the school principal to invite the school to the study. A face to face meeting will also be offered. Recruitment will occur until up to six or eight schools have been recruited. Signed consent forms from principals will be sought to confirm school participation.

Students in Year 7 to 9 of participating schools will be given an information statement describing the study but not group allocation, and a consent form to be handed to their parents requesting permission for their child to participate in data collection time points. A newsletter snippet and a message on the school’s electronic communication channel with parents will be distributed simultaneously to inform parents of the study. One to two weeks following the distribution of the letter, parents who have not returned a consent form or indicated that they do not wish to be contacted, will be phoned by staff employed through the education sector to ask if their child can participate in the data collection. Signed consent forms from parents will be sought to confirm child participation.

Schools that consent to participate will only be randomised following baseline data collection to reduce interviewer and participation bias.

School principals will then receive a letter from the research team informing them of their group allocation. A meeting with the school’s key stakeholders including the principal, canteen committee and school champion will be arranged to provide a brief on the key intervention components such as the guidelines, canteen strategies and lesson plans.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools that consent to participate will be randomised into the intervention or control group using a computerised random number function in Microsoft Excel by an independent statistician not involved in the recruitment, intervention or assessment. Stratification methods may be used if appropriate.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Schools will not be informed of their school’s allocation until after baseline data collection. However, due to the technical impossibility of concealing the environmental and curricular components, participants will not remain blinded for the duration of the study. Nonetheless, they will not be specifically informed of the intervention strategies.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was based on the required detectable difference for changes in SSB consumption to make a difference of clinical significance. Evidence from the literature indicates that a reduction of one serving of SSB per day, equating to a reduction of around 250mL of SSB, significantly decreases the risk of negative health outcomes and behaviours (1,2,3). With a total of 6 schools, assuming 100 students per school year (4) and a 70% consent rate from students in Year 7 to 9, an ICC of 0.02 (based on the recommendation from a review on school-based nutritional interventions (5) to account for potential school clustering effect, a standard deviation for SSB consumption of 0.9 servings (approximately 225mL) (6), this would allow the study to be sensitive enough to detect a daily SSB consumption difference of 81.05mL with 80% power and a significance level of 0.05. This was justified against estimations of a realistic reduction from results from a previous SSB trial that was effective in reducing SSB consumption in adolescents by 1.0-1.5 servings (approximately 250-375mL) per day (6,7,8).

The analyses will be undertaken by an independent statistician blinded to group allocation. The statistician will have no other involvement in this study. The primary outcomes are the mean overall daily energy (kJ) intakes and mean overall daily sugar-sweetened beverage consumption (mL). Both outcomes will be calculated from the student FFQ. Between-group differences at follow-up will be assessed through linear mixed models to account for school level clustering, controlling for baseline values. The study will use an intention to treat approach by including all students with completed FFQ at baseline and dealing with missing data at follow-up by using multiple imputation methods. Subgroup analyses will also be carried out with the data collected from the students when appropriate.

(1) Vartanian LR, Schwartz MB, Brownell KD. Effects of soft drink consumption on nutrition and health: a systematic review and meta-analysis. American journal of public health. 2007 Apr;97(4):667-75.
(2) Chen L, Appel LJ, Loria C, Lin PH, Champagne CM, Elmer PJ, Ard JD, Mitchell D, Batch BC, Svetkey LP, Caballero B. Reduction in consumption of sugar-sweetened beverages is associated with weight loss: the PREMIER trial. The American journal of clinical nutrition. 2009 May 1;89(5):1299-306.
(3) Cochrane T, Davey R, de Castella FR. Estimates of the energy deficit required to reverse the trend in childhood obesity in Australian schoolchildren. Australian and New Zealand journal of public health. 2016 Feb 1;40(1):62-7.
(4) Australian Trade and Investment Commission (Austrade). Schools in Australia. Available from: https://www.studyinaustralia.gov.au/.
(5) Delgado-Noguera M, Tort S, Martínez-Zapata MJ, Bonfill X. Primary school interventions to promote fruit and vegetable consumption: a systematic review and meta-analysis. Preventive medicine. 2011 Aug 31;53(1):3-9.
(6) Ebbeling CB, Feldman HA, Chomitz VR, Antonelli TA, Gortmaker SL, Osganian SK, Ludwig DS. A randomized trial of sugar-sweetened beverages and adolescent body weight. New England Journal of Medicine. 2012 Oct 11;367(15):1407-16.
(7) Smith LH, Holloman C. Piloting “Sodabriety”: A School-Based Intervention to Impact Sugar-Sweetened Beverage Consumption in Rural Appalachian High Schools. Journal of School Health. 2014 Mar 1;84(3):177-84.
(8) Lane H, Porter KJ, Hecht E, Harris P, Kraak V, Zoellner J. Kids SIP smart ER: A Feasibility Study to Reduce Sugar-Sweetened Beverage Consumption Among Middle School Youth in Central Appalachia. American Journal of Health Promotion. 2017 Jul 21:0890117117715052.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2017
Actual
13/02/2018
Date of last participant enrolment
Anticipated
3/11/2017
Actual
13/03/2018
Date of last data collection
Anticipated
27/07/2018
Actual
21/12/2018
Sample size
Target
1260
Accrual to date
Final
1092
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297295 0
Government body
Name [1] 297295 0
NSW Ministry of Health – Translational Research Grant Scheme
Country [1] 297295 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 296267 0
University
Name [1] 296267 0
The University of Newcastle
Address [1] 296267 0
Callaghan Campus, University Drive
Callaghan NSW 2308
Country [1] 296267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298404 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 298404 0
Ethics committee country [1] 298404 0
Australia
Date submitted for ethics approval [1] 298404 0
09/06/2017
Approval date [1] 298404 0
27/07/2017
Ethics approval number [1] 298404 0
17/06/21/4.07
Ethics committee name [2] 298411 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 298411 0
Ethics committee country [2] 298411 0
Australia
Date submitted for ethics approval [2] 298411 0
Approval date [2] 298411 0
Ethics approval number [2] 298411 0
Ethics committee name [3] 298413 0
Diocese of Maitland-Newcastle Catholic Schools Office
Ethics committee address [3] 298413 0
Ethics committee country [3] 298413 0
Australia
Date submitted for ethics approval [3] 298413 0
28/08/2017
Approval date [3] 298413 0
22/09/2017
Ethics approval number [3] 298413 0
Ethics committee name [4] 301015 0
Diocese of Armidale Catholic Schools Office
Ethics committee address [4] 301015 0
Ethics committee country [4] 301015 0
Australia
Date submitted for ethics approval [4] 301015 0
28/08/2017
Approval date [4] 301015 0
Ethics approval number [4] 301015 0
Ethics committee name [5] 301016 0
Diocese of Bathurst Catholic Schools Office
Ethics committee address [5] 301016 0
Ethics committee country [5] 301016 0
Australia
Date submitted for ethics approval [5] 301016 0
07/12/2017
Approval date [5] 301016 0
23/02/2018
Ethics approval number [5] 301016 0
Ethics committee name [6] 301017 0
Diocese of Canberra-Goulburn Catholic Schools Office
Ethics committee address [6] 301017 0
Ethics committee country [6] 301017 0
Australia
Date submitted for ethics approval [6] 301017 0
07/12/2017
Approval date [6] 301017 0
08/12/2017
Ethics approval number [6] 301017 0
Ethics committee name [7] 301018 0
Diocese of Wagga Wagga Catholic Schools Office
Ethics committee address [7] 301018 0
Ethics committee country [7] 301018 0
Australia
Date submitted for ethics approval [7] 301018 0
09/12/2017
Approval date [7] 301018 0
23/01/2018
Ethics approval number [7] 301018 0

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

Contacts
Principal investigator
Name 76978 0
A/Prof Luke Wolfenden
Address 76978 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW Australia 2287
Country 76978 0
Australia
Phone 76978 0
+61 2 4924 6499
Fax 76978 0
+61 2 4924 6490
Email 76978 0
Luke.Wolfenden@hnehealth.nsw.gov.au
Contact person for public queries
Name 76979 0
Rachel Sutherland
Address 76979 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW Australia 2287
Country 76979 0
Australia
Phone 76979 0
+61 2 4924 6133
Fax 76979 0
+61 2 4924 6490
Email 76979 0
Rachel.Sutherland@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 76980 0
Rachel Sutherland
Address 76980 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW Australia 2287
Country 76980 0
Australia
Phone 76980 0
+61 2 4924 6133
Fax 76980 0
+61 2 4924 6490
Email 76980 0
Rachel.Sutherland@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For privacy and confidentiality reasons, individual data will not be released.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2394Study protocol    https://journals.sagepub.com/doi/10.1177/026010601... [More Details]



Results publications and other study-related documents

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