Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000139673
Ethics application status
Approved
Date submitted
3/08/2005
Date registered
12/08/2005
Date last updated
12/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect on Behavior and Bone Mineral Density of Individualized Bone Mineral Density Feedback and Educational Interventions in Premenopausal Women: a Randomized Controlled Trial.
Scientific title
The Effect on Behavior and Bone Mineral Density of Individualized Bone Mineral Density Feedback and Educational Interventions in Premenopausal Women: a Randomized Controlled Trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 229 0
Condition category
Condition code
Musculoskeletal 260 260 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bone mineral density feedback and group
Intervention code [1] 107 0
Prevention
Comparator / control treatment
Leaflet education
Control group
Active

Outcomes
Primary outcome [1] 305 0
Bone mineral density
Timepoint [1] 305 0
At 2 years
Secondary outcome [1] 677 0
Physical activity
Timepoint [1] 677 0
At one and two years.
Secondary outcome [2] 678 0
Fitness
Timepoint [2] 678 0
At one and two years.
Secondary outcome [3] 679 0
Dietary calcium intake and calcium supplement use.
Timepoint [3] 679 0
At one and two years.

Eligibility
Key inclusion criteria
Women aged 25 to 44 years.
Minimum age
25 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects were excluded if they had previously had measurement of bone densitometry, had thyroid disease, renal failure, malignancy or rheumatoid arthritis, had a history of hysterectomy, were on hormone replacement therapy or were pregnant or planning pregnancy within 2 years of study entry, or were lactating.

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)
Participants were allocated a participant number on recruitment. These were consecutive integer values starting at 1. Allocations were implemented from the list of random numbers with no variations to the order in which the numbers were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to recruitment, a random number drawn from a (0,1) uniform distribution (using the random number generator in SAS) was allocated to each participant number. These were rounded to 0 if less than 0.5, or 1 if greater than or equal to 0.5. The 0 or 1 produced the assignment to one of the two intervention groups.
Masking / blinding
Open (masking not 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
2/01/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 315 0
Government body
Name [1] 315 0
NHMRC
Country [1] 315 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 245 0
University
Name [1] 245 0
Queensland University of Technology
Address [1] 245 0
Country [1] 245 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35602 0
Address 35602 0
Country 35602 0
Phone 35602 0
Fax 35602 0
Email 35602 0
Contact person for public queries
Name 9296 0
Tania Winzenberg
Address 9296 0
Menzies Research Institute
Private Bag 23
Hobart TAS 7001
Country 9296 0
Australia
Phone 9296 0
+61 3 62267700
Fax 9296 0
Email 9296 0
[email protected]
Contact person for scientific queries
Name 224 0
Graeme Jones
Address 224 0
Menzies Research Institute
Private Bag 23
Hobart TAS 7001
Country 224 0
Australia
Phone 224 0
+61 3 62267700
Fax 224 0
Email 224 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.