Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000556246
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
8/07/2009
Date last updated
12/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Wollongong Sport: A community-based after-school activity program for overweight and at-risk of overweight 8- to 11-year-old children
Scientific title
The Wollongong Sport pilot randomised controlled trial: Single-sex after-school activity program for overweight and at-risk of overweight 8- to 11-year-old children.
Universal Trial Number (UTN)
Trial acronym
WSP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and at-risk of overweight children 237168 0
Condition category
Condition code
Diet and Nutrition 237493 237493 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Wollongong Sport Physical Activity Program - is a multi-component intervention comprising a homework club and a group physical activity program. The program will run two afternoons a week (Monday and Wednesday for girls, Tuesday and Thursday for boys) between 3pm and 5pm for 30 weeks. It will be delivered on site at our local partner school; a public primary school in the Wollongong region. Participants will take part in a homework club for the first 30 minutes of each afternoon session, where they will complete their prescribed homework under the guidance of the facilitators. Children, who do not have homework, will be provided with worksheets that have been specifically developed for the target age group. A healthy afternoon snack will also be provided at this time. Participants will then participate in 90 min of moderate-intensity physical activity, based on age-appropriate, small-group, sport drills, games and recreational physical activities (themes include, for example, netball/basketball, dance, soccer, touch football). The program activities are designed with an educational focus, with the goal to be fun, engaging and inclusive. For the girls, a dance concert will be performed for parents, siblings and friends at the end of the program, while the boys will participate in a finale soccer match for family and other spectators.
Intervention code [1] 236881 0
Prevention
Comparator / control treatment
Active Control will receive the Wollongong Sport
Healthy Lifestyle Program. This is a state-of-the-art information-based nutrition and health education intervention, delivered once a week from 3:00pm-5:00pm for 30 weeks. This program aims to promote healthy eating and physical activity and reduce time spent in small screen recreation. It will include best-practice information developed by our research centre and previously used in our community-based programs, along with information taken from national documents such as the Australian Guide to Healthy Eating, Dietary Guidelines for Children and Adolescents and Australia’s Physical Activity Recommendations for 5-12 year olds. Each session will also include 20-30 minutes of group physical activities.
Participants will also take part in a homework club for the first 30 minutes of each afternoon session. A healthy afternoon snack will also be provided at this time.

Weekly newsletters will send home for participants and their parents. The newsletters are a maximum of 2 x A4 pages and will focus on physical activity recommendations, small screen recreation guidelines and dietary information aimed at guiding healthy eating choices.
Control group
Active

Outcomes
Primary outcome [1] 238301 0
(1) Body Composition:Percentage Body Fat - Tanita BC-418MA Segmental Body Composition analyser.
Timepoint [1] 238301 0
Baseline (March 2010), post test (30 weeks - November 2010) and follow-up (12 month - March 2011)
Primary outcome [2] 238302 0
Adiposity: (1) Height and weight (used to calculate Body Mass Index [BMI] [kg/m2] and BMI z-score) - Portable stadiometer, and portable electronic scales (BC-418MA Body Composition Analyser); BMI z-score will be calculated using lmsGrowth (Medical Research Council, United Kingdom), to adjust BMI for age- and sex-related changes in height and weight. (2) Wasit Circumference - non-extensible steel tape measure (measured at the level of the mid point between the lower costal border and the iliac crest). (3) Fasting blood tests will be taken by paediatric phlebotomists from a National Association of Testing Authorities (NATA) accredited pathology service to examine change in participants' fasting total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, triglycerides, glucose and insulin. (4) Physical activity - Objective assessments of physical activity and sedentary behaviour will be measured over 8 consecutive days using the GT1M Actigraph accelerometer. (5) The Children's Leisure Activities Study Survey (CLASS) sedentary behaviour questionnaire will also be used in the study to assess time spent in specific small screen recreation activities. Parents will proxy-report their child's time spent watching television, DVDs and videos, and playing on the computer by filling in the CLASS questionnaire, which takes approximately 10 minutes. The CLASS questionnaire is culturally specific to Australian activities and has established validity in primary school children (Telford, Salmon, Jolley & Crawford, 2004). (6) Cardiorespiratory fitness - 20M shuttle run test (Leger & Lambert, 1982).
Timepoint [2] 238302 0
Baseline (March 2010), post test (30 weeks - November 2010) and follow-up (12 month - March 2011)
Secondary outcome [1] 244691 0
Adolescent Measures (Self report):
(1) Domain-specific self-esteem - Self-Perception Profile for Children (Harter, 1985).
(2) Quality of life - The Pediatric Quality of Life Inventory (PedsQL) (Varnie et al., 2003).
All assessed via questionnaires.
Timepoint [1] 244691 0
Baseline (March 2010), post test (30 weeks - November 2010) and follow-up (12 month - March 2011)
Secondary outcome [2] 244694 0
Parent Measures (Self report):
(1) Quality of life - The Pediatric Quality of Life Inventory [Parental report for Child] (PedsQL) (Varnie et al., 2003).
(2) Demographics (household income, parental education, maritial staus, parental weight and height).
All assessed via questionnaires.
Timepoint [2] 244694 0
Baseline (March 2010), post test (30 weeks - November 2010) and follow-up (12 month - March 2011)

Eligibility
Key inclusion criteria
Participants will be: 1) classified as overweight or obese (Cole et al, 2000) OR 2) will have a body mass index (BMI) =75th percentile (using UK reference values) AND will have at least one of the following risk factors: 1) have one parent with a BMI =25 kg/m2, 2) be currently not meeting Australian physical activity guidelines for children (60min/day of moderate-to-vigorous physical activity), or 3) be identified as having low self-esteem/perceptions of competence by their parent. Participants will be healthy, that is not have a medical condition or be taking medication that influences their growth; have the ability to participate in moderate-intensity physical activity; be available to attend the program on the two designated afternoons each week; and be willing to be randomised into either the intervention or active placebo group.
Minimum age
8 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with extreme obesity (BMI Standard Deviation [SD] score > 4), known syndromal causes of obesity, long term oral steroids, medications known to be associated with weight gain, chronic illness.

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)
Recruitment will commence in November 2009, prior to the program start date in March 2010.
Numerous recruitment strategies will be employed to enhance recruitment success.

Thirty girls and thirty boys, aged 8- to 11-years, will be recruited from our partner school and 10 local primary schools which have a high proportion of students from low-income neighbourhoods. (1) Advertisements will be placed in school newsletters and (2) an information session will be held at our partner school. (3) A Wollongong Sport hotline will be set-up for all enquiries (potential participants will be screened to see if they meet the eligibility criteria) and then information sheets and consent forms will be sent to the parents. (4) School teachers will also be asked to identify children with low perceived physical competence, enjoyment of physical activity or who are generally not active. (5) A ‘trial session’ will be offered to potential participants prior to the commencement of the program, which will allow children and parents to meet the program facilitators and trial the activities. This strategy was successful in the previous feasibility trials and will be supported by a presentation to parents, outlining the philosophy and goals of the program and the study.

Once written consent is received, participants will be randomized into either the intervention group (The Wollongong Sport Physical activity Program) or the control group (The Wollongong Sport Healthy Lifestyles Program). Allocation was concealed: central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed following baseline measurements to minimise withdrawal. Participants will be stratified by gender and randomised, using a computer-based random number-producing algorithm and the biased-coin method, to either the Wollongong Sport Program (WSP) intervention group or the active placebo group by the consultant statistician. To prevent allocation bias, the researcher recruiting participants will be kept blind to the allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two-arm pilot randomized controlled trial (intervention and control group)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237287 0
Government body
Name [1] 237287 0
Foundation for Children
Country [1] 237287 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 236770 0
None
Name [1] 236770 0
Address [1] 236770 0
Country [1] 236770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239373 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 239373 0
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 239373 0
Australia
Date submitted for ethics approval [1] 239373 0
22/07/2009
Approval date [1] 239373 0
05/11/2009
Ethics approval number [1] 239373 0
HE09-235

Summary
Brief summary
The Wollongong Sport pilot randomised controlled trial (RCT) aims to test the potential efficacy of a community-based after-school sports program designed for overweight and at-risk of overweight boys and girls. We propose that participation in the gender-specific programs (Wollongong Sport Physical Activity Program) will improve children’s weight status, blood profiles, physical activity, fitness, self-esteem and health-related quality of life, compared with children participating in an active placebo program (Wollongong Sport Healthy Lifestyle Program).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29854 0
Address 29854 0
Country 29854 0
Phone 29854 0
Fax 29854 0
Email 29854 0
Contact person for public queries
Name 13101 0
Dr Dylan Cliff
Address 13101 0
Faculty of Education
University of Wollongong
Wollongong NSW 2522
Country 13101 0
Australia
Phone 13101 0
+61 2 4221 5929
Fax 13101 0
+61 2 4221 3892
Email 13101 0
[email protected]
Contact person for scientific queries
Name 4029 0
Associate Professor Tony Okely
Address 4029 0
Faculty of Education
University of Wollongong
Wollongong NSW 2522
Country 4029 0
Australia
Phone 4029 0
+61 2 4221 4641
Fax 4029 0
+61 2 4221 3892
Email 4029 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
No additional documents have been identified.