Trial Review

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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
29/11/2021
Date data sharing statement initially provided
29/11/2021
Date results information initially provided
29/11/2021
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
Secondary ID [1] 305923 0
Nil Known
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
Usual care
Control group
Placebo

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

Eligibility
Key inclusion criteria
Type 1 diabetes.
Minimum age
11 Years
Maximum age
18 Years
Sex
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
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
Completed
Date of first participant enrolment
Anticipated
19/09/2005
Actual
19/09/2005
Date of last participant enrolment
Anticipated
Actual
1/03/2007
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
100
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 172 0
New Zealand
State/province [1] 172 0
Wellington

Funding & Sponsors
Funding source category [1] 566 0
Charities/Societies/Foundations
Name [1] 566 0
Wellington Medical Research Foundation
Country [1] 566 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Wellington Medical Research Foundation
Address
Research For Life
(Wellington Medical Research Foundation Inc.)
PO Box 14186
Kilbirnie
Wellington 6241
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
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 1588 0
New Zealand
Date submitted for ethics approval [1] 1588 0
Approval date [1] 1588 0
01/08/2005
Ethics approval number [1] 1588 0
CEN/05/08/058

Summary
Brief summary
This study aimed to assess whether pedometers and text messaging increase physical activity in adolescents with type 1 diabetes. A 12-week randomized controlled trial was
conducted. A total of 78 subjects participated in the trial (mean  SD age 14.4  2.37 years, 36
[47%] male). Intervention participants wore an open pedometer and received regular motivational text messages. Control participants received usual care. Primary outcomes were daily step count (4-day closed pedometer) and physical activity questionnaire.
Trial website
Trial related presentations / publications
NEWTON K, WHILTSHIRE E, ELLEY CR “Pedometers and Text Messaging to Increase Physical Activity: Randomized controlled trial of adolescents with type 1 diabetes” Diabetes Care 2009, 32 (5)
Public notes

Contacts
Principal investigator
Name 35979 0
Ms Kirsty Newton
Address 35979 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 35979 0
New Zealand
Phone 35979 0
+64 4 3855995
Fax 35979 0
Email 35979 0
[email protected]
Contact person for public queries
Name 9561 0
Ms 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
[email protected]
Contact person for scientific queries
Name 489 0
A/Prof Dr C. Raina Elley
Address 489 0
Dept Gen Prac and PHC,
Faculty Medical and Health Sciences,
University of Auckland,
Private Bag 92019,
Auckland
Country 489 0
New Zealand
Phone 489 0
+64 9 3737599
Fax 489 0
Email 489 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data no longer available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes NEWTON K, WHILTSHIRE E, ELLEY CR “Pedometers and T... [More Details]

Documents added automatically
No additional documents have been identified.