Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000176268
Ethics application status
Approved
Date submitted
23/03/2009
Date registered
16/04/2009
Date last updated
16/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using pedometers to increase physical activity
Scientific title
Using pedometers to increase physical activity in the overweight and obese
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
increasing physical activity in the overweight and obese 4519 0
Condition category
Condition code
Public Health 4803 4803 0 0
Health promotion/education
Cardiovascular 4908 4908 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chronic , randomised, parallel study where twenty six overweight and obese middle-aged women were randomized into the control group or the pedometer group.At baseline, both groups were then given the National Australian Physical Activity Guidelines. At baseline, information from these guidelines such as intensity, duration, prompts for exercise (ie, stairs or elevators) and relapse prevention etc were reviewed with the subjects in both groups. The pedometer group was also encouraged to reach a daily step goal of 10,000 steps/day for 12 weeks. The pedometer group was allowed free acess to their pedometers to record and observe their steps on a daiy basis. No step goals were set for the control group for 12 weeks. The control group wore sealed pedometers and did not have access to their pedometers on a daily basis for 12 weeks.
Intervention code [1] 4372 0
Lifestyle
Comparator / control treatment
The control group was not able to record their steps on a daily basis, whilst the pedometer group, were asked to record the number of steps on a daily basis for 12 weeks. The control group wore a sealed pedometer for 12 weeks and therefore had no knowledge of their record of steps/day. Total steps were recorded on a weekly basis (steps/week) on a calendar.At baseline, the control group were then given the National Australian Physical Activity Guidelines. At baseline, information from these guidelines such as intensity, duration, prompts for exercise (ie, stairs or elevators) and relapse prevention etc were reviewed with the subjects. They were not given a step/day goal.
Control group
Placebo

Outcomes
Primary outcome [1] 5662 0
Primary outcomes was to measure ncreased physical activity in the form of pedometer steps.The pedometer group wore an unsealed pedometer. Hence they were able to open, observe and record their number of steps performed throughout the day. Participants in the pedometer group were instructed to record accumulated steps/day on a calendar and to reset the pedometer to zero each day. The control group wore a sealed pedometer for 12 weeks and therefore had no knowledge of their record of steps/day. Control groups was asked to record their total steps on a weekly basis (steps/week) on a calendar. The control group were then asked to reset the pedometer to zero each week and seal the pedometer with tape.
Timepoint [1] 5662 0
measured at baseline, 6 and 12 weeks
Secondary outcome [1] 241549 0
body weight, body mass index {BMI}
Timepoint [1] 241549 0
measured at baseline and 12 weeks

Eligibility
Key inclusion criteria
Not on regular medications
Non-smoker
35 - 55 yrs old
sedentary
overweight and obese women
(body mass index {BMI} > 25 and < 35 kg/m2)
Minimum age
35 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included current chronic medical and psychological disease, major systemic illness, renal failure, pregnancy, lactating or planning to become pregnant, smoking, hypothyroidism, diabetes mellitus, pre-existing heart conditions or gastrointestinal surgery and greater than two hours of moderate intensity physical activity per week.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin-tossing
Masking / blinding
Blinded (masking 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
30/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4706 0
Government body
Name [1] 4706 0
Healthway, Western Australia
Country [1] 4706 0
Australia
Primary sponsor type
Government body
Name
Healthway, WA
Address
PO Box 1284
West Perth WA 6872
Country
Australia
Secondary sponsor category [1] 4251 0
None
Name [1] 4251 0
Address [1] 4251 0
Country [1] 4251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6740 0
Curtin University Ethics commitee
Ethics committee address [1] 6740 0
Ethics committee country [1] 6740 0
Australia
Date submitted for ethics approval [1] 6740 0
Approval date [1] 6740 0
19/11/2003
Ethics approval number [1] 6740 0
HR 179/2003

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

Contacts
Principal investigator
Name 29428 0
Address 29428 0
Country 29428 0
Phone 29428 0
Fax 29428 0
Email 29428 0
Contact person for public queries
Name 12675 0
Associate Professor Sebely Pal
Address 12675 0
School of Public Health
Curtin University
GPO Box U1987
WA 6845
Country 12675 0
Australia
Phone 12675 0
+61 8 9266 4755
Fax 12675 0
+61 8 9266 2958
Email 12675 0
[email protected]
Contact person for scientific queries
Name 3603 0
Associate Professor Sebely Pal
Address 3603 0
School of Public Health
Curtin University
GPO Box U1987
WA 6845
Country 3603 0
Australia
Phone 3603 0
+61 8 9266 4755
Fax 3603 0
+61 8 9266 2958
Email 3603 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.