Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001685404
Ethics application status
Approved
Date submitted
2/11/2016
Date registered
8/12/2016
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised trial of a school-based health promotion intervention: Shake-a-Leg
Scientific title
A cluster randomised trial of a school-based health promotion intervention: Shake-a-Leg
Secondary ID [1] 290155 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 300275 0
Inadequate Nutrition 300276 0
Condition category
Condition code
Public Health 300143 300143 0 0
Health promotion/education
Diet and Nutrition 300144 300144 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a two level cluster randomised controlled design where the primary cluster is the school and the secondary cluster is the class. Eligible schools who agree to participate in the study will be stratified by school size and geographic location then randomly allocated to either intervention or control group. The term in which the school participates in the trial will also be randomly allocated at this time.

Intervention Schools
During weeks 2 to 7 of the school term, students in intervention schools will receive the Shake-A-Leg program; one session per week, during class time for approximately 40 minutes. Students will also receive additional Physical Activity and Nutrition content at each of these sessions for approximately 5 minutes. Session will be delivered by qualified Aboriginal Health workers

Overview of Session content themes and main learning objectives Years 5 & 6:

Session 1: Identity
Learn ‘what is identity’
Understand the various ways people express their identity
Work as part of a team
Express identity using artwork
Learn ways to maintain identity

Session 2: Physical Activity:
Understand the importance of exercise
Understand daily recommendations of physical activity for children

Session 3: Nutrition
Build confidence in choosing healthy food and drink
Understand the five food groups
Make informed healthy food choices
Distinguish difference between ‘everyday foods’ and ‘sometimes foods’

Session 4: Oral Health
Learn what a healthy mouth looks like
Learn about plaque and tooth decay
Learn how plaque affects your teeth – carries process
Learn preventative measures – brushing, flossing, and treatment
Understand the importance of healthy eating
Learn the effects on teeth when we consume sometimes food and drinks too much or too often

Session 5: Alcohol and other drugs
Learn ‘what is a drug’
Gain an understanding of the different types of drugs
Understand the negative effects of alcohol, cannabis and tobacco use and what to look for in noticing these effects
Think of ways they may respond if offered drugs

Session 6: Bullying
Learn ‘what is bullying’
Understand the emotional impact bullying can have on the victims
Work as part of a team
Recognise the different ways to handle bullying

Data collection
Data will be collected using paper-based questionnaires by trained research assistants from Hunter New England Local Health District (HNELHD) Aboriginal Health Unit and Population Health Unit. Data collection will be conducted in all participating schools (intervention and control) at two points. Baseline data during week 1 of their allocated school term and post-intervention data will be collected in week 8 of the same term. All data will be re-identifiable, with each child being allocated a unique study number so that baseline and post-intervention data can be matched.

Attendance of participating students will be recorded at each session. Data from students who did not attend at least four sessions, two of which must be physical activity and nutrition, will be excluded from analysis.
Intervention code [1] 295907 0
Lifestyle
Intervention code [2] 295908 0
Behaviour
Intervention code [3] 295909 0
Prevention
Comparator / control treatment
Schools allocated to the control group will participate in the data collection components of the trial only. Students will only receive regularly delivered physical activity teaching and promotion practices according to the PDHPE curriculum and locally determined school-based initiatives.
Control group
Active

Outcomes
Primary outcome [1] 299629 0
Nutrition. Assessed via participant self-report using nutrition-behaviour questions from the NSW Schools Physical Activity and nutrition Survey (SPANS)
Timepoint [1] 299629 0
Seven weeks post-baseline
Primary outcome [2] 299630 0
Physical Activity Participation. Assessed via seven-day self-report questionnaire based on the Adolescent Physical Activity Recall Questionnaire (APARQ).
Timepoint [2] 299630 0
Seven weeks post-baseline
Primary outcome [3] 299733 0
Knowledge of physical activity. Assessed via participant self-report using investigator developed items inclusive of options that reflect the Australian guidelines on young people and physical activity
Timepoint [3] 299733 0
seven weeks post-baseline
Secondary outcome [1] 327713 0
Knowledge of nutrition (primary outcome). Assessed via participant self-report using investigator developed items inclusive of options that reflect the Australian guidelines for healthy eating in childhood.
Timepoint [1] 327713 0
seven weeks post-baseline (post-intervention)
Secondary outcome [2] 327963 0
Nutrition Self-efficacy. Assess via participant self-report using the following 5 questions from the Dewar Nutrition Self-Efficacy scale.
1) I find it difficult to choose low-fat foods when they are available (e.g. “lite” milk rather than “full cream” milk).
2) I find it difficult to choose healthy meals/ snacks when I am with my friends.
3) I find it easy to eat 2 servings of fruit each day.
4) I find it easy to eat 5 servings of vegetables/salad each day.
5) I find it easy to have healthy portion sizes during meals (e.g. eating a larger serving of veggies or salad than meat)
Timepoint [2] 327963 0
seven weeks post-baseline (post-intervention)
Secondary outcome [3] 327973 0
Physical Activity Self-efficacy. Assess via participant self-report using the following 5 questions from the Dewar Physical Activity Self-Efficacy scale.
1) When I’m physically active (e.g. during PE or school sport) I get embarrassed about my fitness or skill level.
2) I can still find the time to be physically active even when I’ve had a busy day.
3) I find it difficult to be physically active when the weather is bad, (e.g. too hot, too cold or raining)
4)I find it difficult to be physically active when I have no one to be active with.
5) I do not feel comfortable using local facilities to be physically active (e.g. the gym, beach, skate parks, bike paths).
Timepoint [3] 327973 0
seven weeks post-baseline (post-intervention)
Secondary outcome [4] 328439 0
Oral health knowledge. Assessed via participant self-report using investigator developed items inclusive of options that reflect Australian guidelines for oral heath.
Timepoint [4] 328439 0
seven weeks post-baseline (post-intervention)
Secondary outcome [5] 328440 0
Oral health behaviour. Assessed via participant self-report using investigator developed items inclusive of options that reflect the Australian guidelines on oral health
Timepoint [5] 328440 0
seven weeks post-baseline (post-intervention)

Eligibility
Key inclusion criteria
For schools to be eligible to participate in the SAL study they must meet the following criteria:
1) Located within the Hunter New England Local Health District (HNELHD)
2) A Public Government School
3) A K-6 primary school with at least one year five and/or year six class
4) Minimum of 100 students and >= 10 % Aboriginal student population, or a minimum of 80 students with an Aboriginal student population of =>50%
5) Student has Parent or guardian consent to participate
Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Private Schools
2) Central Schools
3) k-2 Schools
4) All students in years k-4 attending participating schools
5) Composite classes of 4/5
6) Students at participating schools who do not have consent provided by their parent or guardian
7) Classes in participating schools catering for students with severe physical and mental disabilities will be excluded from the sample.

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)
Proportional stratified random sampling will be used to randomise participating schools. Randomisation by using a randomisation table created by computer software facilitated by an independent statistician. Schools will be randomised in to intervention or control groups with a 50/50 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be allocated to study groups using a block randomisation for each combination of stratification level. Randomisation will be created using the PLAN procedure in SAS 9.3
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size (addressed in section 7) refers to the required sample size for Aboriginal Students.

To detect a statistically significant change in Aboriginal students with probability (power) 0.8, an alpha level of 0.05, an intra-cluster correlation of 0.5 and control group prevalence of 50%, the trial will require 466 eligible Aboriginal participants (233 per study group) at follow-up.

When accounting for an estimated average of 20% Aboriginal student population among eligible schools, an 80% parental consent rate, and a 10% loss to follow up, it is estimated that 3200 total students will be invited to participate in the trial, including 644 Aboriginal students.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/01/2017
Actual
6/02/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
466
Accrual to date
106
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294561 0
Government body
Name [1] 294561 0
Hunter New England Local Health District - Aboriginal Health Unit
Country [1] 294561 0
Australia
Funding source category [2] 294593 0
Government body
Name [2] 294593 0
Hunter New England Population Health Unit
Country [2] 294593 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District Aboriginal Health Unit
Address
Aboriginal Health Unit
Longworth Avenue
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 293430 0
Government body
Name [1] 293430 0
Hunter New England Local Health District - Population Health Unit
Address [1] 293430 0
Population Health Unit
Longworth Avenue
Wallsend NSW 2287
Country [1] 293430 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295996 0
Hunter New England Human Research Ethics Committee (HREC)
Ethics committee address [1] 295996 0
Ethics committee country [1] 295996 0
Australia
Date submitted for ethics approval [1] 295996 0
15/10/2015
Approval date [1] 295996 0
07/06/2016
Ethics approval number [1] 295996 0
15/10/21/4.06
Ethics committee name [2] 296024 0
State Education Research Applications Process (SERAP)
Ethics committee address [2] 296024 0
Ethics committee country [2] 296024 0
Australia
Date submitted for ethics approval [2] 296024 0
04/07/2016
Approval date [2] 296024 0
Ethics approval number [2] 296024 0
Ethics committee name [3] 296026 0
Aboriginal Health and Medical Research Council (AH&MRC) Ethics Committee
Ethics committee address [3] 296026 0
Ethics committee country [3] 296026 0
Australia
Date submitted for ethics approval [3] 296026 0
29/09/2015
Approval date [3] 296026 0
15/04/2016
Ethics approval number [3] 296026 0
1118/15

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

Contacts
Principal investigator
Name 69054 0
Ms Karen Gillham
Address 69054 0
HNE Population Health Unit
Locked Bag 10
WALLSEND NSW 2287
Country 69054 0
Australia
Phone 69054 0
+ 61 2 4924 6022
Fax 69054 0
Email 69054 0
[email protected]
Contact person for public queries
Name 69055 0
Meghan Macdonald
Address 69055 0
Hunter New England Population Health
Po Box 35
Taree, NSW
2430
Country 69055 0
Australia
Phone 69055 0
+ 61 2 6515 1858
Fax 69055 0
Email 69055 0
[email protected]
Contact person for scientific queries
Name 69056 0
Daniel Groombridge
Address 69056 0
HNE Population Health
Locked Bag 10
WALLSEND NSW 2287
Country 69056 0
Australia
Phone 69056 0
+ 61 2 4924 6696
Fax 69056 0
Email 69056 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
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