Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001044314
Ethics application status
Approved
Date submitted
10/07/2017
Date registered
18/07/2017
Date last updated
24/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An intervention to support the promotion of healthier environments at junior sports clubs: study protocol.
Scientific title
A cluster randomised controlled trial of a multi-component intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol.
Secondary ID [1] 292401 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 303969 0
Smoking 304004 0
Poor nutrition 304005 0
Physical inactivity 304006 0
Behavioural environment practices 304007 0
Condition category
Condition code
Public Health 303322 303322 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of the intervention is to assist junior sports clubs implement the following 16 policies and practices:
1) Alcohol is not available or consumed during junior competition;
2) Alcohol is not available or consumed at junior events or presentations;
3) Alcohol is not present in the change rooms when under 18 players are present;
4) Alcohol manufacturers, wholesalers, retailers or other businesses whose core function is to sell alcohol are not promoted or advertised by the club on any junior apparel;
5) Alcohol is not used for prizes, rewards or for fundraising;
6) The club is compliant with the relevant state tobacco legislation;
7) The club promotes all junior events as smoke free;
8) Water is promoted as the drink of choice for junior players;
9) Multiple healthy food and beverage (e.g. fruit, vegetables and non-sugar sweetened drink) options are available at the canteen or barbeque;
10) The purchase of healthy choices at the canteen or barbeque are promoted by ensuring healthy food and beverage options are displayed prominently
11) The club encourages parents to provide healthy snacks (e.g. fruit and water) for junior players
12) The club has a Participation Policy that it communicates to members, coaches, officials and volunteers to ensure junior players are provided with equal opportunities for participation at both training and during games;
13) The club conducts at least one recruitment activity per year prior to the beginning of the winter sporting season to attract new junior players and retain current players;
14) The club has a Code of Conduct Policy which it communicates to all members, and ensures member agreement is recorded;
15) The club has a Spectator Behaviour Policy that is promoted and clearly visible at the club;
16) The club has a written Good Sports Junior policy, which outlines the club’s practices with regards to alcohol consumption, tobacco use, healthy eating and physical activity.

The intervention will consist of face-to-face, web- and phone-based support to assist junior sporting clubs implement health promoting practices. Implementation support will be provided over one winter sports season in Australia, which usually runs for 6 months (March to August). Implementation support staff will be based at the Alcohol and Drug Foundation. Support staff will not be required to have any particular qualifications, however they will have experience in previous Good Sports Service Delivery. Support staff will offer assistance to intervention clubs by contacting them three times by email and three times by phone throughout the intervention period, with the mode of contact alternating each month. The first phone contact will last for approximately 30 minutes and will focus on reviewing the clubs current practices, which support staff will record using an online customer relationship management (CRM) system. The CRM system will then generate action plans which will help clubs to identify the practices they need to implement. Resources will be sent to clubs after the first telephone contact including posters to hang at the club and news templates about topics such as healthy snacks, code of conduct, and alcohol free events that clubs can use on their social media pages, websites or club newsletters. The remaining two phone calls will check on the clubs progress in implementing the identified practices and will last for around 10-15 minutes. The three email contacts from support staff will identify practices that clubs might like to focus on in the coming month. Support staff will encourage club representatives to provide evidence of the implementation of the intervention strategies via the upload of policies, photos, and copies of emails to club members onto the online CRM system. In addition to the six contacts initiated by support staff, automated theme-based emails will also be sent to clubs monthly throughout the sporting season. These emails will each contain content relevant to the five themes of: 1) conduct; 2) healthy eating; 3) alcohol; 4) smoking; and 5) member conduct. For example, the automated alcohol themed email will emphasise the importance of changing the club’s culture around alcohol for junior members and include some key messages for the club to share on their social media pages. The messages will be included at the end of the email so clubs can copy these messages directly onto their Facebook, Instagram, or Twitter pages. Key messages for the alcohol email will include short sentences about the potential risks and harms of alcohol consumption, and the importance of role-modelling for junior players.

The intervention will also include the following evidence-based strategies to support implementation:

1. Management support – research staff will be allocated time to speak to club representatives about the research study at a Football League meeting, which all clubs attend. Football Leagues will endorse the intervention to their clubs via email and encourage their clubs participation and progress through the program.

2. Policies and procedures – club representatives will be provided with hardcopy and electronic templates to assist clubs develop health promotion policies. Examples of recruitment strategies that can be used to attract new junior players to the club, and retain current players, will also be supplied.

3. Recognition and reward systems – clubs will be provided with ongoing recognition of progress (e.g. upon completion of an action item, at monthly contacts) to promote sustained engagement. Progress will be recognised and rewarded with a certificate of accreditation. A digital asset pack (copy and paste templates for the club’s social media pages and website) will be provided to clubs when they have achieved accreditation. Clubs will also be provided with a ‘case study template’ that they can provide to their local media outlet, which will showcase their participation in the program.

4. Information systems – a customer relationship management (CRM) system will allow research staff to monitor the progress of each club towards achieving the intervention criteria and provide real time feedback.
Clubs will be provided with tailored action plans generated by the CRM system.

5. Systems and prompts – electronic reminders (e.g. emails) will be used to prompt the implementation of pre-specified health promotion practices.

6. Informal culture – clubs will be encouraged to select rounds of the junior competition, or a junior event, to focus on promoting the intervention informally (i.e. the alcohol awareness round, or the healthy juniors round).

7. External courses – clubs will be provided with an alcohol management toolkit to increase awareness of alcohol legislation and best practice strategies to manage alcohol in their setting.

8. Human resources – research staff will be allocated to help clubs implement the intervention. These research staff will also monitor and provide feedback on implementation of practices. Assistance will be provided via regular phone and email contact with individual club representatives (once per month) during the winter season to maintain support.

9. Physical resources – a comprehensive kit of hard copy resources will be provided to clubs upon commencement of participation. The kit will include: posters promoting alcohol free junior competitions; alcohol free change room signs; a list of alternate prizes to alcohol; smoke-free posters; a canteen whiteboard to promote healthy food and beverage options prominently; a safe food handling poster; letter templates for clubs to send to parents to encourage them to provide healthy snacks for juniors; a playing environment sign with the Good Sports code of conduct prominently displayed, and other similar signs, posters and letter templates. Clubs will be provided with policy templates for all of the targeted behaviours (alcohol, smoking, healthy eating, physical activity and playing environment). Additionally, electronic versions of resources will be provided to junior clubs throughout winter season via email, including the policy templates, posters and signage. All toolkits and resources in the intervention have been developed by the Alcohol and Drug Foundation. Links to industry experts (i.e. healthy food and beverage suppliers) will also be provided. A lead sporting person for each participating football code (AFL or Rugby League) will endorse the intervention through hard-copy and digital (e.g. video) resources.
Intervention code [1] 298574 0
Behaviour
Comparator / control treatment
Control clubs will not receive any support or resources from the research team throughout the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 302714 0
The mean number of policies and practices (out of 16) implemented by junior sporting clubs. Assessed as the number of policies and practices (out of 16) the junior sporting club has implemented, as reported by the junior club representative via a telephone interview designed by the research team for the study.
Timepoint [1] 302714 0
The baseline telephone interview will occur in July-September 2016 and the post-intervention telephone interview will occur in August-September 2017.
Secondary outcome [1] 336790 0
The proportion of junior sporting clubs where, in the past season, alcohol was not available or consumed during junior competition. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, alcohol was not available or consumed during junior competition. The telephone survey will be designed by the research team for the study.
Timepoint [1] 336790 0
The baseline telephone interview will occur in July-September 2016 and the post-intervention telephone interview will occur in August-September 2017.
Secondary outcome [2] 336791 0
The proportion of junior sporting clubs where, in the past season, alcohol was not available or consumed at junior events or presentations. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, alcohol was not available or consumed at junior events or presentations. The telephone survey will be designed by the research team for the study.
Timepoint [2] 336791 0
The baseline telephone interview will occur in July-September 2016 and the post-intervention telephone interview will occur in August-September 2017.
Secondary outcome [3] 336792 0
The proportion of junior sporting clubs where, in the past season, alcohol was not present in the change rooms when under 18 players were present. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, alcohol was not present in the change rooms when under 18 players were present. The telephone survey will be designed by the research team for the study.
Timepoint [3] 336792 0
The baseline telephone interview will occur in July-September 2016 and the post-intervention telephone interview will occur in August-September 2017.
Secondary outcome [4] 336794 0
The proportion of junior sporting clubs where, in the past season, alcohol manufacturers, wholesalers, retailers or other businesses whose core function is to sell alcohol were not promoted or advertised by the club on any junior apparel. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, alcohol manufacturers, wholesalers, retailers or other businesses whose core function is to sell alcohol were not promoted or advertised by the club on any junior apparel. The telephone survey will be designed by the research team for the study.
Timepoint [4] 336794 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [5] 336949 0
The proportion of junior sporting clubs where, in the past season, alcohol was not used for prizes, rewards or for fundraising. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, alcohol was not used for prizes, rewards or for fundraising. The telephone survey will be designed by the research team for the study.
Timepoint [5] 336949 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [6] 336950 0
The proportion of junior sporting clubs where, in the past season, the club was compliant with the relevant state tobacco legislation. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, the club was compliant with the relevant state tobacco legislation. The telephone survey will be designed by the research team for the study.
Timepoint [6] 336950 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [7] 336951 0
The proportion of junior sporting clubs where, in the past season, all junior events were promoted as smoke free. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, all junior events were promoted as smoke free. The telephone survey will be designed by the research team for the study.
Timepoint [7] 336951 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [8] 336952 0
The proportion of junior sporting clubs where, in the past season, water was promoted as the drink of choice for junior players. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, water was promoted as the drink of choice for junior players. The telephone survey will be designed by the research team for the study.
Timepoint [8] 336952 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [9] 336953 0
The proportion of junior sporting clubs where, in the past season, multiple healthy food and beverage (e.g. fruit, vegetables and non-sugar sweetened drink) options were available at the canteen or barbeque. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, multiple healthy food and beverage (e.g. fruit, vegetables and non-sugar sweetened drink) options were available at the canteen or barbeque. The telephone survey will be designed by the research team for the study.
Timepoint [9] 336953 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [10] 336954 0
The proportion of junior sporting clubs where, in the past season, the purchase of healthy choices at the canteen or barbeque was promoted by ensuring healthy food and beverage options were displayed prominently. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, the purchase of healthy choices at the canteen or barbeque was promoted by ensuring healthy food and beverage options were displayed prominently. The telephone survey will be designed by the research team for the study.
Timepoint [10] 336954 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [11] 336955 0
The proportion of parents and guardians of junior members where, in the past season, the club encouraged them to bring healthy snacks for junior players by providing information about healthy snacks and the club’s policy about healthy snacks to parents. Assessed as the proportion of parents and guardians of junior members who report via a telephone interview that, in the past season, the club encouraged them to bring healthy snacks for junior players by providing information about healthy snacks and the club’s policy about healthy snacks to parents. The telephone survey will be designed by the research team for the study.
Timepoint [11] 336955 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [12] 336956 0
The proportion of junior sporting clubs where, in the past season, they had implemented a Participation Policy that it communicated to members, coaches, officials and volunteers to ensure junior players are provided with equal opportunities for participation at both training and during games. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, they had implemented a Participation Policy that it communicated to members, coaches, officials and volunteers to ensure junior players are provided with equal opportunities for participation at both training and during games. The telephone survey will be designed by the research team for the study.
Timepoint [12] 336956 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [13] 336957 0
The proportion of junior sporting clubs where, in the past season, they have conducted at least one recruitment activity prior to the beginning of the winter sporting season to attract new junior players and retain current players. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, they have conducted at least one recruitment activity prior to the beginning of the winter sporting season to attract new junior players and retain current players. The telephone survey will be designed by the research team for the study.
Timepoint [13] 336957 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [14] 336958 0
The proportion of junior sporting clubs where, in the past season, they had implemented a Code of Conduct Policy which it communicated to all members, and ensures member agreement is recorded. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, they had implemented a Code of Conduct Policy which it communicated to all members, and ensures member agreement is recorded. The telephone survey will be designed by the research team for the study.
Timepoint [14] 336958 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [15] 336959 0
The proportion of junior sporting clubs where, in the past season, they had implemented a Spectator Behaviour Policy that was promoted and clearly visible at the club. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, they had implemented a Spectator Behaviour Policy that was promoted and clearly visible at the club. The telephone survey will be designed by the research team for the study.

Timepoint [15] 336959 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [16] 336960 0
The proportion of junior sporting clubs where, in the past season, they had implemented a written Good Sports Junior policy, which outlined the club’s practices with regards to alcohol consumption, tobacco use, healthy eating and physical activity. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, they had implemented a written Good Sports Junior policy, which outlined the club’s practices with regards to alcohol consumption, tobacco use, healthy eating and physical activity. The telephone survey will be designed by the research team for the study.
Timepoint [16] 336960 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [17] 336961 0
Child exposure to alcohol. Assessed as proportion of parents of children at the club who report during telephone interview that, in the past season, they have not consumed alcohol at the club during junior matches or events. The telephone survey will be designed by the research team for the study.
Timepoint [17] 336961 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [18] 336962 0
Child exposure to tobacco. Assessed as proportion of parents of children at the club who report during telephone interview that, in the past season, they have not smoked tobacco at the club during junior matches or events. The telephone survey will be designed by the research team for the study.
Timepoint [18] 336962 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [19] 336963 0
Child healthy eating food purchases at the club. Assessed as proportion of parents of children at the club who report during telephone interview that, in the past season, a healthy food item was usually purchased from the club canteen by or for their child. The telephone survey will be designed by the research team for the study.
Timepoint [19] 336963 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [20] 336964 0
Child healthy drink purchases at the club. Assessed as proportion of parents of children at the club who report during telephone interview that, in the past season, a healthy beverage was usually purchased from the club canteen by or for their child. The telephone survey will be designed by the research team for the study.
Timepoint [20] 336964 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [21] 336965 0
Equal participation for children in training and games. Assessed as proportion of parents of children at the club who report during telephone interview that, in the past season, they agree or strongly agree that their child spent as much time involved in training and on the field during games as other children in their team. The telephone survey will be designed by the research team for the study.
Timepoint [21] 336965 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [22] 336966 0
A safe playing environment for children. Assessed as proportion of parents of children at the club who report during telephone interview that, in the past season, they have signed the club’s Code of Conduct policy in the past season. The telephone survey will be designed by the research team for the study.
Timepoint [22] 336966 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [23] 336967 0
Opportunities for regular physical activity for children. Assessed as number of junior players (under 18 years) registered to play at the club as reported by the leagues that clubs belong to. Research staff will request this information from the leagues directly.
Timepoint [23] 336967 0
Baseline data collection: July-September 2016
Post-intervention data collection: August-September 2017
Secondary outcome [24] 337245 0
The proportion of junior sporting clubs where, in the past season, the club encouraged parents to provide healthy snacks (e.g., fruit and water) for junior players. Assessed as the proportion of junior club representatives who report via a telephone interview that, in the past season, the club encouraged parents to provide healthy snacks (e.g., fruit and water) for junior players. The telephone survey will be designed by the research team for the study.
Timepoint [24] 337245 0
Baseline data collection: July-September 2016 Post-intervention data collection: August-September 2017

Eligibility
Key inclusion criteria
Eligibility criteria for Football Leagues:
- are an Australian Football League (AFL) in Victoria or a Rugby or Country Rugby League in NSW
- are a community-level (non-professional) League
- are not currently involved in any other research trial
- have 10 or more clubs which meet Level 3 accreditation with the Good Sports program
- have 10 or more junior clubs

Eligibility criteria for Junior Football Clubs:
- belong to an eligible League
- are accredited as a Level 3 Good Sports club
- have > 40 junior (U18) players

Eligibility criteria for Junior Football Club Representatives:
- are nominated as the representative for an eligible junior club (e.g. president, secretary, committee member)
- are over 18 years of age
- speak English

Eligibility criteria for Junior Player’s Parents/Guardians:
- are a parent or guardian of a young person who is a player at an eligible junior club
- are over 18 years of age;
- speak English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Do not satisfy the above listed inclusion criteria.

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)
Randomisation will occur at the level of the League. Leagues will be matched on code (AFL or Rugby) and jurisdiction (Victoria or NSW) and randomly allocated to an experimental condition in a 1:1 ratio. The randomisation sequence will be computer generated by an independent statistician. Randomisation at the League level will mean that clubs within the League are block randomised to either the intervention or control condition. League randomisation will occur post-baseline data collection (i.e. once all club representative and parent/guardian telephone interviews have been completed). Due to the nature of the intervention, clubs will not be blind to their experimental group allocation. However, telephone interviewers collecting the post-intervention data from club representatives and parents/guardians will not know whether participants are from intervention or control clubs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A Microsoft Excel random-number generation program will be run by an independent statistician to allocate Leagues to either the intervention or control condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the demographic characteristics of participating clubs and club representatives, as well as the mean number of practices and policies implemented by the club.

For the primary outcome, a linear regression model will be implemented under an intention to treat approach to compare group differences on the mean number of practices and policies at follow-up, adjusting for baseline values. Sub-group analyses will be conducted by introducing group by sub-group interaction terms into the linear model for: football code (AFL vs Rugby League), and geographic location (metropolitan vs regional) using the Australian Standard Geographic Classification System based on the club’s postcode. All analyses will be conducted using SAS (V9.3 or later).

For the secondary outcomes, Generalised linear mixed model analysis will be used to examine between group differences to account for potential clustering effect. The models will be implemented under an intention to treat approach, adjusting for baseline values.

The alpha value for significance testing will be 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
31/07/2016
Date of last data collection
Anticipated
30/09/2017
Actual
Sample size
Target
90
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 296953 0
Charities/Societies/Foundations
Name [1] 296953 0
NIB Foundation Multi-Partnership Grant
Country [1] 296953 0
Australia
Funding source category [2] 296955 0
Charities/Societies/Foundations
Name [2] 296955 0
Cancer Council NSW Program Grant
Country [2] 296955 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Alcohol and Drug Foundation
Address
Level 12, 607 Bourke Street
Melbourne Victoria 3000
Australia
Country
Australia
Secondary sponsor category [1] 295958 0
University
Name [1] 295958 0
The University of Newcastle
Address [1] 295958 0
The University of Newcastle
University Drive,
Callaghan NSW 2308
Australia
Country [1] 295958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298158 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 298158 0
Ethics committee country [1] 298158 0
Australia
Date submitted for ethics approval [1] 298158 0
20/10/2015
Approval date [1] 298158 0
21/10/2015
Ethics approval number [1] 298158 0
H-2013-0429

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

Contacts
Principal investigator
Name 76178 0
Ms Sharin Milner
Address 76178 0
Alcohol and Drug Foundation
Level 12, 607 Bourke Street
Melbourne Victoria 3000
Country 76178 0
Australia
Phone 76178 0
+61 3 9611 6141
Fax 76178 0
Email 76178 0
[email protected]
Contact person for public queries
Name 76179 0
Sharin Milner
Address 76179 0
Alcohol and Drug Foundation
Level 12, 607 Bourke Street
Melbourne Victoria 3000
Country 76179 0
Australia
Phone 76179 0
+61 3 9611 6141
Fax 76179 0
Email 76179 0
[email protected]
Contact person for scientific queries
Name 76180 0
Luke Wolfenden
Address 76180 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 76180 0
Australia
Phone 76180 0
+61 2 4924 6567
Fax 76180 0
Email 76180 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: Study protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-018906
N.B. These documents automatically identified may not have been verified by the study sponsor.