Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000134224
Ethics application status
Approved
Date submitted
13/01/2009
Date registered
27/02/2009
Date last updated
5/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Western Sydney Adolescent Sport and Physical Activity Program (WASPA): A pilot program to manage obesity among adolescents.
Scientific title
Effect of a Community-Based After School Program on Preventing Unhealthy Weight Gain among Overweight and Obese Adolescents.
Universal Trial Number (UTN)
Trial acronym
WASPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obese adolescents 4189 0
Condition category
Condition code
Diet and Nutrition 4398 4398 0 0
Obesity
Other 4632 4632 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) The WASPA Physical Activity Program - Community based after school physical activity and healthy eating program conducted at a local community setting (leisure centre). The physical activity and healthy eating program focuses on increasing adolescents’ fitness, sporting skills, and physical activity, and improving their food habits and eating behaviours. The program will run for 20 weeks, with two 1.5 hour sessions each week. Adolescents will also be asked to complete two ‘additional’ physical activity sessions in their own time each week. The activities are designed to be enjoyable and to develop self-efficacy among participants whilst also accommodating their unique needs.

Parents will be asked to attend five dietary education sessions with an accredited practising dietitian. The adolescents will also participate separately in five sessions as part of the programme. These are aimed at guiding healthy eating choices through improving knowledge about portion sizes and label reading skills and preparing healthy alternatives such as afternoon snacks and meals.
Intervention code [1] 4116 0
Behaviour
Comparator / control treatment
Active control Receive the 'State-of-the-art information-based health education program'. Adolescents and parents will be asked to attend five monthly sessions and to read the monthly newsletters. The session duration is approximately 1-1.5 hours and the newsletters are a maximum on 2 x A4 pages. sessions and newsletters will focus on physical activity recommendations, small screen recreation guidelines and dietary information sessions aimed at guiding healthy eating choices through improving knowledge about portion sizes and label reading.
Control group
Active

Outcomes
Primary outcome [1] 5281 0
Anthropometric
1) Height and Weight (Body mass index "BMI")- Portable stadiometer, and portable electronic scales
2_Waist Circumference - non-extensible tape measure
3) Percentage Body Fat - Tanita BC-418 Segmental Body Composition Analyser
4) Resting Heart Rate - Polar heart rate monitor
5)Resting blood pressure - Dinamao automated blood pressure monitor
5) Fasting Lipids (total cholesterol "TC", High-density lipoproteins "HDL-C", Low-density lipoproteins "LDL-C", triglycerides; insulin; glucose) - Blood samples after overnight fast
Timepoint [1] 5281 0
Baseline and 6-month follow-up
Primary outcome [2] 5282 0
1) Physical Activity - MTI Actigraph Accelerometers
2) Cardiorespiratory fitness - 20M shuttle run test
3) Muscular Strength and power - Grip dynamometer, standing long jump
4) Functional strength - prone hold, sit-to-stand
Timepoint [2] 5282 0
Baseline and 6-month follow-up (Demographics only taken at baseline)
Secondary outcome [1] 8893 0
Adolescent Measures (Self-report)
Quality of life, Psychosocial Well-being, Food habits, Body image and eating behaviours - all assessed via questionnaires.
Timepoint [1] 8893 0
Baseline and 6-month follow-up
Secondary outcome [2] 8894 0
Parent Measure
Quality of life, Demographics (household income, parental education, marital status, parent education level), Adverse events/injuries)- all assessed via questionnaires.
Timepoint [2] 8894 0
Baseline and 6-month follow-up (Demographics only taken at baseline)

Eligibility
Key inclusion criteria
1. The adolescent will need to be overweight or obese as defined by Body Mass Index "BMI" according to International Obesity Task Force cut-off points for age and gender.
2. At least one parent would need to attend all required dietary sessions (5 in total, which run from 4-5:30pm in the given weeks), and only one adolescent from each family can enrol.
3. The adolescent needs to be between 12 and 16 years of age (they can be turning 12 before March 2009).
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Adolescents with extreme obesity (Body Mass Index Standard Deviation score greater than 4 "BMI SD score > 4.0") will not be eligible.
2. No known syndromal causes of obesity, long term oral steroids, medications known to be associated with weight gain, chronic illness, or significant dietary restriction.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment will commence approximately 6 weeks before the program commences. Numerous recruitment strategies will be employed to enhance recruitment success and include: personalised letters sent to school Principals inviting them to promote the study within their school and in school newsletters articles and posters places in general Practitioner (gp) surgeries, shopping centers and public libraries. The University of Wollongong media unit will distribute media releases resulting in newspaper articles and radio and television interviews and finally paid advertisements will be placed in local newspapers.

Interested participants will be sent an information package containing an information sheet and a consent form. Once written consent is received from both participants and their parents, participants will be randomized into either the intervention group or the control group.

Allocation was concealed: central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The bias coin method of allocation, using a computer-based random number-producing algorithm will be used for randomisation. This method ensures an equal chance of allocation to each group. Stratification by gender will be done to ensure an equal representation in groups. Only one study member will have access to the allocation codes and these will be stored on a pass-word protected computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two arm randomised controlled trial (intervention and control groups)
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4369 0
University
Name [1] 4369 0
University of Wollongong
Country [1] 4369 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 3935 0
Other
Name [1] 3935 0
Fairfield Community Leisure Centre
Address [1] 3935 0
Vine Street
Fairfield NSW 2165
Country [1] 3935 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35083 0
Address 35083 0
Country 35083 0
Phone 35083 0
Fax 35083 0
Email 35083 0
Contact person for public queries
Name 12430 0
Associate Professor Tony Okely
Address 12430 0
Faculty of Education. Building 67
University of Wollongong
wollongong NSW 2522
Country 12430 0
Australia
Phone 12430 0
+61 2 4221 4641
Fax 12430 0
+61 2 4221 3892
Email 12430 0
[email protected]
Contact person for scientific queries
Name 3358 0
Associate Professor Tony Okely
Address 3358 0
Faculty of Education. Building 67
University of Wollongong
wollongong NSW 2522
Country 3358 0
Australia
Phone 3358 0
+61 2 4221 4641
Fax 3358 0
+61 2 4221 3892
Email 3358 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.