Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000102673
Ethics application status
Approved
Date submitted
3/08/2005
Date registered
9/08/2005
Date last updated
9/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A community based primary prevention programme in New Zealand for children & adolescents at risk of NIDDM by modifying some associated risk factors: a randomised controlled trial
Scientific title
A community based primary prevention programme in New Zealand for children & adolescents at risk of non insulin dependent diabetes mellitus (NIDDM, Type 2) by modifying some associated risk factors: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes prevention 183 0
Insulin resistance in children and adolescents 184 0
Condition category
Condition code
Public Health 208 208 0 0
Diabetes
Public Health 209 209 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An 8-week progressive resistance training programme in 10-15 year olds twice a week. Free weights and ankle weights are used to complete 11 exercises covering the major muscle groups of the body.
Intervention code [1] 106 0
Prevention
Comparator / control treatment
A waitlist control group were invited to movies as a group during the intervention phase.
Control group
Active

Outcomes
Primary outcome [1] 247 0
Waist cirumference
Timepoint [1] 247 0
Measured at baseline and at 8-weeks.
Secondary outcome [1] 565 0
1RM arm & leg strength, VO2peak, lipids, glucose, insulin, HOMA2-IR, height, weight, BMI, hip circumference, maturation, BIA, physical activity.
Timepoint [1] 565 0
All outcomes are measured at baseline and at 8 weeks.
Secondary outcome [2] 566 0
Questionnaires on self efficacy, self concept, physical activity & inactivity, lifestyle information relating to nutrition, smoking, physical activity & diabetes knowledge.
Timepoint [2] 566 0
All outcomes are measured at baseline and at 8 weeks.
Secondary outcome [3] 567 0
During each training session adherence, training intensity (RPE, weight, reps) were measured.
Timepoint [3] 567 0
All outcomes are measured at baseline and at 8 weeks.

Eligibility
Key inclusion criteria
10-15 years in year 7-10 at Intermediate or High School in Gore, New Zealand.
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical conditions or physical injury identify a risk, medications affecting heart rate, cognitive impairment preventing informed consent.

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)
Concealed to researcher in sealed envelopes until interventions were assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random sequence stratified by age and gender to allocate to either the training or wait-list control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
wait-list control
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264 0
University
Name [1] 264 0
University of Sydney
Country [1] 264 0
Australia
Funding source category [2] 265 0
Charities/Societies/Foundations
Name [2] 265 0
Invercargill South Lions Club Diabetes Services Development Trust
Country [2] 265 0
New Zealand
Funding source category [3] 266 0
Government body
Name [3] 266 0
Southland District Health Board
Country [3] 266 0
New Zealand
Funding source category [4] 267 0
Other
Name [4] 267 0
Southern Institute of Technology
Country [4] 267 0
New Zealand
Primary sponsor type
University
Name
University of Sydney, School of exercise & sport science
Address
Country
Australia
Secondary sponsor category [1] 200 0
None
Name [1] 200 0
nil
Address [1] 200 0
Country [1] 200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1091 0
University of Sydney Human Ethics Committee
Ethics committee address [1] 1091 0
Ethics committee country [1] 1091 0
Australia
Date submitted for ethics approval [1] 1091 0
Approval date [1] 1091 0
Ethics approval number [1] 1091 0
Ethics committee name [2] 1092 0
New Zealand Health Research Council: Southland Ethics Committtee
Ethics committee address [2] 1092 0
Ethics committee country [2] 1092 0
New Zealand
Date submitted for ethics approval [2] 1092 0
Approval date [2] 1092 0
Ethics approval number [2] 1092 0

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

Contacts
Principal investigator
Name 36207 0
Address 36207 0
Country 36207 0
Phone 36207 0
Fax 36207 0
Email 36207 0
Contact person for public queries
Name 9295 0
Amanda Benson
Address 9295 0
School of Exercise & Sport Science
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 9295 0
Australia
Phone 9295 0
+64 27 4413145 (NZ Number)
Fax 9295 0
Email 9295 0
acbkiwi@clear.net.nz
Contact person for scientific queries
Name 223 0
Amanda Benson
Address 223 0
School of Exercise & Sport Science
University of Sydney
Cumberland Campus
PO Box 170
Lidcombe NSW 1825
Country 223 0
Australia
Phone 223 0
+64 27 4413145 (NZ Number)
Fax 223 0
Email 223 0
acbkiwi@clear.net.nz

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.