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Trial registered on ANZCTR


Registration number
ACTRN12605000339651
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
9/09/2005
Date last updated
5/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Activity Pedometer Trial (RAPT)
Scientific title
Randomised Activity Pedometer Trial (RAPT): randomised controlled trial of pedometers and text messaging in adolescents with Type 1 diabetes to increase physical activity over 12 weeks
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity in adolescents with Type 1 diabetes 432 0
Condition category
Condition code
Metabolic and Endocrine 503 503 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pedometers and text messaging.
Intervention code [1] 372 0
Lifestyle
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 574 0
Physical activity (steps per day and self-report)
Timepoint [1] 574 0
Secondary outcome [1] 1224 0
Serum HbA1c
Timepoint [1] 1224 0
Secondary outcome [2] 1225 0
Body Mass Index z-score
Timepoint [2] 1225 0
Secondary outcome [3] 1226 0
Blood pressure
Timepoint [3] 1226 0
Secondary outcome [4] 1227 0
Adherence to diabetes self-management
Timepoint [4] 1227 0
Secondary outcome [5] 1228 0
Quality of life
Timepoint [5] 1228 0

Eligibility
Key inclusion criteria
Type 1 diabetes.
Minimum age
11 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to walk or unable to comprehend study instructions.

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)
Sealed, opaque, numbered envelopes opened after enrolment and baseline measures. Outcome assessor remains blind to allocation of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence obtained from STATA by independent researcher in random blocks of different sizes, stratified by diabetes centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 172 0
New Zealand
State/province [1] 172 0

Funding & Sponsors
Funding source category [1] 566 0
Charities/Societies/Foundations
Name [1] 566 0
Wellington Medical Research Foundation
Address [1] 566 0
PO Box 51 211
Wellington
New Zealand
Country [1] 566 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Wellington Medical Research Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 458 0
Charities/Societies/Foundations
Name [1] 458 0
Sport and Recreation New Zealand (SPARC)
Address [1] 458 0
PO Box 2251, Wellington 6140,
New Zealand
Country [1] 458 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1588 0
Central Region Ethics Committee
Ethics committee address [1] 1588 0
Ethics committee country [1] 1588 0
New Zealand
Date submitted for ethics approval [1] 1588 0
Approval date [1] 1588 0
Ethics approval number [1] 1588 0
CEN/05/08/058

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

Contacts
Principal investigator
Name 35979 0
Address 35979 0
Country 35979 0
Phone 35979 0
Fax 35979 0
Email 35979 0
Contact person for public queries
Name 9561 0
Kirsty Newton
Address 9561 0
Department of Primary Health Care and General Practice
Wellington School of Medicine and Health Sciences
University of Otago
PO Box 7343
Wellington 6001
Country 9561 0
New Zealand
Phone 9561 0
+64 4 3855995
Fax 9561 0
Email 9561 0
kirsty.newton@wipa.org.nz
Contact person for scientific queries
Name 489 0
Dr C. Raina Elley
Address 489 0
Department of Primary Health Care and General Practice
Wellington School of Medicine and Health Sciences
University of Otago
PO Box 7343
Wellington 6001
Country 489 0
New Zealand
Phone 489 0
+64 4 3855999 (Ext. 6122)
Fax 489 0
Email 489 0
c.elley@wnmeds.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary