Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001078246
Ethics application status
Approved
Date submitted
15/12/2009
Date registered
16/12/2009
Date last updated
30/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Can strength training change the strength, body shape and self esteem of overweight teenage boys?
Scientific title
Can resistance training change the strength, body composition and self-concept of overweight and obese adolescent males? A randomised controlled trial.
Secondary ID [1] 1202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 'adolescent males' 252340 0
Condition category
Condition code
Public Health 252531 252531 0 0
Other public health
Mental Health 252532 252532 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-month resistance training program that will consist of three 1-hour sessions every week. Ten multi-joint exercises will performed at each session and and a trainer to particiant ratio of 1:2 will be maintained. This will ensure that the particiants lifting technique is correct and the appropriate feedback and encouragement is received.
Intervention code [1] 255652 0
Other interventions
Intervention code [2] 255705 0
Lifestyle
Comparator / control treatment
Will be instructed to continue on with normal everyday activities.
Control group
Active

Outcomes
Primary outcome [1] 253414 0
To improve self-concept.
This will be measured via questionnaires.
Timepoint [1] 253414 0
3-months into intervention, after the intervention (6-months) and at follow-up (12-months)
Secondary outcome [1] 262520 0
To improve body composition.
This will be assessed via Dual Energy X-Ray Absorptiometry (DEXA) scans and also anthropometric measures such as skinfolds and girths. This will allow percent body fat and lean body mass to be assessed.
Timepoint [1] 262520 0
3-months into intervention, after the intervention (6-months) and at follow-up (12-months)
Secondary outcome [2] 262521 0
To improve strength.
This will be assessed using one-repetition maximum testing for bench and leg press.
Timepoint [2] 262521 0
3-months into intervention, after the intervention (6-months) and at follow-up (12-months)

Eligibility
Key inclusion criteria
The participants Body Mass Index (BMI) must be equal to or greater than the 85th percentile according to age-sex specific data collected in the 2007 National Children’s Nutrition and Physical Activity Survey.
Minimum age
13 Years
Maximum age
17 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are classed as < Tanner stage 2.
Participants are categorised as a high risk by the Sports Medicine Australia pre-exercise screening questionnaire and do not obtain a medical clearance.
Participants have current or have had previous injuries which would prevent them from participating in resistance training (e.g. knee reconstruction).
Participants exhibit musculoskeletal conditions which would place them ‘at risk’ as a result resistance training (e.g. severe scoliosis).

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)
Participants were staggered into the study. Upon completing baseline testing each participant was assigned a number (e.g. first participant to complete basleine testing was assigned number 1 etc.). Each number had already been randomly assigned with a group allocation which was revealed to the participant (and the Principal investigator) after baseline testing was complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Before recruitment began an impartial individual, using a random number genererator, produced a random list of group allocation for a possible 70 participants (i.e. each number was assigned as a 1 or 0 with 1 = intervention and 0 = control). Each group allocation was written on a piece of paper and concealed inside a non-transparent envelope which was sealed and the corresponding participant number written on the outside. The principal investigator only opened each envelope when a participant completed baseline testing and was assigned a randomisation number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Random effects mixed modelling was used to assess the effect of the intervention and analysis was done on an intention-to-treat basis.
Per protocol regression analysis was also performed to determine whether training attendance had an effect on each outcome.
Mediation analysis was also run with strength and body composition outcomes as the independent variables, exercise self-efficacy, physical self-worth and self-esteem as the dependent variables and training attendance as the mediator.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
8/03/2010
Date of last participant enrolment
Anticipated
Actual
2/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256131 0
Self funded/Unfunded
Name [1] 256131 0
Natasha Schranz
Country [1] 256131 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 251472 0
None
Name [1] 251472 0
Address [1] 251472 0
Country [1] 251472 0
Other collaborator category [1] 988 0
Individual
Name [1] 988 0
Professor Timothy Olds
Address [1] 988 0
Room C7-41, City East Campus, University of South Australia, GPO Box 2471, Adelaide, SA 5001
Country [1] 988 0
Australia
Other collaborator category [2] 989 0
Individual
Name [2] 989 0
Doctor Grant Tomkinson
Address [2] 989 0
Room C7-31, City East Campus, University of South Australia, GPO Box 2471, Adelaide, SA 5001
Country [2] 989 0
Australia
Other collaborator category [3] 1005 0
Individual
Name [3] 1005 0
Dr Natalie Parletta
Address [3] 1005 0
Room BJ1-41, City East Campus, University of South Australia, GPO Box 2471, Adelaide, SA 5001
Country [3] 1005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258221 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 258221 0
Ethics committee country [1] 258221 0
Australia
Date submitted for ethics approval [1] 258221 0
07/09/2009
Approval date [1] 258221 0
13/11/2009
Ethics approval number [1] 258221 0
P258/09

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

Contacts
Principal investigator
Name 30580 0
Mrs Natasha Schranz
Address 30580 0
Room C7-42, City East Campus, University of South Australia, GPO Box 2471, Adelaide, SA 5001
Country 30580 0
Australia
Phone 30580 0
+61 8 8302 1285
Fax 30580 0
Email 30580 0
[email protected]
Contact person for public queries
Name 13827 0
Natasha Schranz
Address 13827 0
Room C7-42, City East Campus, University of South Australia, GPO Box 2471, Adelaide, SA 5001
Country 13827 0
Australia
Phone 13827 0
+61 8 8302 1285
Fax 13827 0
Email 13827 0
[email protected]
Contact person for scientific queries
Name 4755 0
Natasha Schranz
Address 4755 0
Room C7-42, City East Campus, University of South Australia, GPO Box 2471, Adelaide, SA 5001
Country 4755 0
Australia
Phone 4755 0
+61 8 8302 1285
Fax 4755 0
Email 4755 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.