Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000991213
Ethics application status
Not yet submitted
Date submitted
16/11/2009
Date registered
17/11/2009
Date last updated
17/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Resistance weight training to improve body composition and biochemical markers in obese adolescents with varying metabolic profiles: a randomised controlled trial
Scientific title
Resistance weight training to improve body composition and biochemical markers in obese adolescents with varying metabolic profiles: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adolescent obesity 252221 0
impaired glucose tolerance 252222 0
Condition category
Condition code
Metabolic and Endocrine 252408 252408 0 0
Diabetes
Diet and Nutrition 252410 252410 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
16 week resistance training exercise protocol: 3 45-minute exercise sessions per week, involving 1 circuit of 22 exercises (12 repetitions per exercise) at 80% of the 1-repetition maximum (1-RM)
Intervention code [1] 241561 0
Treatment: Other
Comparator / control treatment
control group will be asked to maintain normal lifestyles for 16 weeks, with pre- and post-testing assessments.
Control group
Active

Outcomes
Primary outcome [1] 253283 0
body composition (i.e. % body fat, body weight, lean body mass) via dual x-ray absorptiometry (DEXA) scan
Timepoint [1] 253283 0
before and after the 16 week intervention
Primary outcome [2] 253284 0
markers of insulin resistance (i.e. fasting glucose, fasting insulin) via serum analysis.
Timepoint [2] 253284 0
before and after the 16 week intervention
Secondary outcome [1] 262298 0
markers of inflammation (i.e. Interleukin-1 [IL-1], Interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-alpha], C-reactive protein [CRP]) via serum analysis
Timepoint [1] 262298 0
before and after the 16 week intervention
Secondary outcome [2] 262299 0
muscle strength (1-RM for 22 exercises)
Timepoint [2] 262299 0
before and after the 16 week intervention; after every 12th exercise session for the intervention group (in order to progress the resistive load)

Eligibility
Key inclusion criteria
Body mass index (BMI) >30 kg/m2
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of cardiovascular conditions, neuromusculoskeletal disease, or musculoskeletal injury or surgery within the past 6 months

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)
Medical clearance is necessary for prior to pre-intervention testing. The physician who is determining eligibility will not know which group the participant will be assigned to. However, allocation will not be concealed to the investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be used through computerised sequence generation
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2010
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)
Recruitment postcode(s) [1] 2220 0
4001
Recruitment postcode(s) [2] 2221 0
4002
Recruitment postcode(s) [3] 2222 0
4003
Recruitment postcode(s) [4] 2223 0
4004
Recruitment postcode(s) [5] 2224 0
4005
Recruitment postcode(s) [6] 2225 0
4006
Recruitment postcode(s) [7] 2226 0
4007
Recruitment postcode(s) [8] 2227 0
4008
Recruitment postcode(s) [9] 2228 0
4009
Recruitment postcode(s) [10] 2229 0
4010
Recruitment postcode(s) [11] 2230 0
4011
Recruitment postcode(s) [12] 2231 0
4012
Recruitment postcode(s) [13] 2232 0
4013
Recruitment postcode(s) [14] 2233 0
4014
Recruitment postcode(s) [15] 2234 0
4029
Recruitment postcode(s) [16] 2235 0
4030
Recruitment postcode(s) [17] 2236 0
4031
Recruitment postcode(s) [18] 2237 0
4032
Recruitment postcode(s) [19] 2238 0
4033
Recruitment postcode(s) [20] 2239 0
4034
Recruitment postcode(s) [21] 2240 0
4053
Recruitment postcode(s) [22] 2241 0
4054
Recruitment postcode(s) [23] 2242 0
4055
Recruitment postcode(s) [24] 2243 0
4059
Recruitment postcode(s) [25] 2244 0
4060
Recruitment postcode(s) [26] 2245 0
4061
Recruitment postcode(s) [27] 2246 0
4064
Recruitment postcode(s) [28] 2247 0
4065
Recruitment postcode(s) [29] 2248 0
4066
Recruitment postcode(s) [30] 2249 0
4067
Recruitment postcode(s) [31] 2250 0
4068
Recruitment postcode(s) [32] 2251 0
4069
Recruitment postcode(s) [33] 2252 0
4070
Recruitment postcode(s) [34] 2253 0
4101

Funding & Sponsors
Funding source category [1] 244030 0
Other Collaborative groups
Name [1] 244030 0
Australian Technology Network, Centre for Metabolic Fitness
Country [1] 244030 0
Australia
Primary sponsor type
Individual
Name
Sarah Shultz
Address
60 Musk Avenue
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 251375 0
None
Name [1] 251375 0
Address [1] 251375 0
Country [1] 251375 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258134 0
Ethics committee address [1] 258134 0
Ethics committee country [1] 258134 0
Date submitted for ethics approval [1] 258134 0
22/10/2009
Approval date [1] 258134 0
Ethics approval number [1] 258134 0

Summary
Brief summary
Excess fat mass, associated with adolescent obesity, has been related to insulin resistance and inflammatory markers, which increase the risk of health conditions such as cardiovascular disease, metabolic syndrome, and type 2 diabetes. Exercise is an appropriate intervention for obesity and type 2 diabetes, but research has not investigated the benefits of resistance training for obese adolescents. The purpose of this study is to understand the benefits of resistance training on body composition, biochemical markers, aerobic fitness, and muscular strength in obese adolescents. The project will include a 16-week resistance training exercise program (3 sessions per week) with two testing sessions before and after. The testing sessions will include a full body scan (to measure body composition), a blood sample (to measure biochemical markers), a VO2Max test (to measure aerobic fitness) and a strength test. This project will build a stronger foundation for more relevant recommendations for exercise in obese adolescents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30517 0
Address 30517 0
Country 30517 0
Phone 30517 0
Fax 30517 0
Email 30517 0
Contact person for public queries
Name 13764 0
Sarah Shultz
Address 13764 0
60 Musk Avenue
Kelvin Grove, QLD 4059
Country 13764 0
Australia
Phone 13764 0
+61 7 3138 6096
Fax 13764 0
+61 7 3138 6030
Email 13764 0
sarah.shultz@qut.edu.au
Contact person for scientific queries
Name 4692 0
Sarah Shultz
Address 4692 0
60 Musk Avenue
Kelvin Grove, QLD 4059
Country 4692 0
Australia
Phone 4692 0
+61 7 3138 6096
Fax 4692 0
+61 7 3138 6030
Email 4692 0
sarah.shultz@qut.edu.au

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

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