Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000644460
Ethics application status
Approved
Date submitted
17/12/2007
Date registered
19/12/2007
Date last updated
19/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ‘Fitness Improvement, Lifestyle Awareness’ Program: A secondary school fitness and lifestyle program for adolescent boys.
Scientific title
The 'Fitness Improvement, Lifestyle Awareness' Program: A secondary school fitness and lifestyle program to improve cardiorespiratory fitness and prevent unhealthy weight gain in adolescent boys
Universal Trial Number (UTN)
Trial acronym
The FILA Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low cardiorespiratory fitness
Adolescent overweight/obesity
Physical inactivity 2636 0
Condition category
Condition code
Public Health 2751 2751 0 0
Health promotion/education
Diet and Nutrition 2752 2752 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial was a 6-month 2-arm parallel group pilot randomized controlled trial at an Independent Boys High School in the Eastern suburbs of Sydney. The participants were randomized to either the intervention or ‘active’ control programs. The intervention program consisted of 15x60min theory and practical sessions focusing on cardiorespiratory fitness, healthy eating, small screen recreation and behaviour modification and 22x20min lunchtime activity sessions.
Intervention code [1] 2371 0
Prevention
Intervention code [2] 2372 0
Lifestyle
Intervention code [3] 2373 0
Behaviour
Comparator / control treatment
The ‘active’ control participants received the standard treatment (usual curricular fitness program taught by a PDHPE Faculty member) consisting of 15x60-minute activity sessions.
Control group
Active

Outcomes
Primary outcome [1] 3640 0
Primary outcome 1: Cardiorespiratory fitness (measured using the Multi-stage fitness test)
Timepoint [1] 3640 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [1] 6108 0
Secondary outcome 1: Body mass index
Timepoint [1] 6108 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [2] 6109 0
Secondary outcome 2: Waist circumference
Timepoint [2] 6109 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [3] 6110 0
Secondary outcome 3: Body composition measured by the Tanita Body Fat monitor (Tanita Corp., Tokyo, Japan)
Timepoint [3] 6110 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [4] 6111 0
Secondary outcome 4: Objectively measured physical activity - MTI Actigraph (MTI Health Services, Fort Walton Beach, Florida, USA)
Timepoint [4] 6111 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [5] 6112 0
Secondary outcome 5: Health-Related Quality of Life (HR-QOL)
Timepoint [5] 6112 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [6] 6113 0
Secondary outcome 6: Fruit and sweetened beverage consumption - Food Frequency Questionnaire
Timepoint [6] 6113 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)
Secondary outcome [7] 6114 0
Secondary outcome 7: Time spent in small screen recreation viewing - Adolescent Sedentary Activities Questionnaire (ASAQ)
Timepoint [7] 6114 0
Timepoint: at pre-test and post-test (24 weeks after pre-test)

Eligibility
Key inclusion criteria
Sixty students with the lowest cardio-respiratory results were invited to participate in the trial. According to the NSW SPANS survey, in comparison to other boys of similar age, these targeted boys’ cardio-respiratory fitness results were lower than the 50th percentile (Booth et al., 2006).

Booth, M., Okely, A.D., Denney-Wilson, E., Hardy, L.L., Yang, B. & Dobbins, T. (2006). NSW Schools Physical Activity and Nutrition Survey (SPANS) 2004: Full report. Sydney: NSW Department of Health.
Minimum age
11 Years
Maximum age
13 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Boys only in 7th grade who attended the school the trial was being conducted. Those students with medium to high levels of cardio-respiratory fitness (above the 50th percentile) were not invited to participate in the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer using bias coin method of allocation. The allocation code was only known by one of the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 345 0
2023

Funding & Sponsors
Funding source category [1] 2891 0
Other
Name [1] 2891 0
The Scots College
Country [1] 2891 0
Australia
Primary sponsor type
Individual
Name
Dr Tony Okely
Address
Child Obesity Research Centre
Faculty of Education
University of Wollongong
Northfields Ave
Wollongong NSW
Country
Australia
Secondary sponsor category [1] 2612 0
Individual
Name [1] 2612 0
Dr Rachel Jones
Address [1] 2612 0
Child Obesity Research Centre
Faculty of Education
University of Wollongong
Northfields Ave
Wollongong NSW
Country [1] 2612 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4833 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 4833 0
Research Services Office
University of Wollongong
Northfields Ave
Wollongong NSW
Ethics committee country [1] 4833 0
Australia
Date submitted for ethics approval [1] 4833 0
Approval date [1] 4833 0
28/03/2007
Ethics approval number [1] 4833 0
HE06/011

Summary
Brief summary
To evaluate the feasibility, acceptability and potential efficacy of a multi-faceted curriculum-based fitness and lifestyle program among adolescent boys.
Trial website
N/A
Trial related presentations / publications
Poster presentations of proof-of-concept trial:
1. 15th European Congress on Obesity. Budapest, Hungary, April 22-25, 2007
2. Australian Conference of Science and Sports Medicine in Sport Sixth National Physical Activity Conference. Adelaide, Australia, October 13-16, 2007.
Public notes

Contacts
Principal investigator
Name 28246 0
Address 28246 0
Country 28246 0
Phone 28246 0
Fax 28246 0
Email 28246 0
Contact person for public queries
Name 11403 0
Louisa Peralta
Address 11403 0
PhD Candidate
Child Obesity Research Centre
Faculty of Education
University of Wollongong
Northfields Ave
Wollongong NSW
Country 11403 0
Australia
Phone 11403 0
+61 42 215551
Fax 11403 0
Email 11403 0
[email protected]
Contact person for scientific queries
Name 2331 0
Dr Tony Okely
Address 2331 0
Child Obesity Research Centre
Faculty of Education
University of Wollongong
Northfields Ave
Wollongong NSW
Country 2331 0
Australia
Phone 2331 0
+61 42 214641
Fax 2331 0
Email 2331 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.