Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000521527
Ethics application status
Approved
Date submitted
9/12/2006
Date registered
18/12/2006
Date last updated
18/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Persian Gulf Women's Healthy Heart
Scientific title
Effects of a community-based healthy heart program on increasing healthy women's physical activity: a randomized controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generally healthy women 1496 0
Condition category
Condition code
Public Health 1593 1593 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 335 healthy, 25-64 years old women, were randomized into control and intervention groups. The intervention group completed an 8 week lifestyle modification program for increasing their physical activity, based on a revised form of Choose to Move program; an American Heart Association Physical Activity Program for Women. Audio-taped activity instructions with music and practical usage of the educational package (4 booklets and weekly newsletters) were given to the intervention group in weekly home-visits by 53 volunteers from local non-governmental and community-based organizations.
Intervention code [1] 1494 0
Lifestyle
Comparator / control treatment
After baseline measurements and receiving the results of their laboratory tests with a general medical recommendation, the control group received no education.
Control group
Active

Outcomes
Primary outcome [1] 2197 0
Amount of physical activity
Timepoint [1] 2197 0
Measured at baseline and immediately after the end of intervention
Primary outcome [2] 2198 0
Score of heart knowledge
Timepoint [2] 2198 0
Measured at baseline and immediately after the end of intervention
Primary outcome [3] 2199 0
Total cholestrol level
Timepoint [3] 2199 0
Measured at baseline and immediately after the end of intervention
Secondary outcome [1] 3832 0
Moderate and vigorous intensity physical activity
Timepoint [1] 3832 0
18 weeks, 6 and 12 months

Eligibility
Key inclusion criteria
Generally healthy.
Minimum age
25 Years
Maximum age
64 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History or evidence of angina pectoris, myocardial infarction, cerebral stroke, renal disease, severe arthritis, lung disease, or drug consumption.

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 envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Age group and health center number was used for stratification. The first random number selected by Microsoft excel for selection of intervention group in a systematic random sampling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blinded within this study
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
589
Accrual to date
Final
Recruitment outside Australia
Country [1] 442 0
Iran, Islamic Republic Of
State/province [1] 442 0

Funding & Sponsors
Funding source category [1] 1738 0
University
Name [1] 1738 0
Bushehr University of Medical Science
Country [1] 1738 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Bushehr University of Medical Science
Address
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 1533 0
Government body
Name [1] 1533 0
Bushehr Provincial Technology and Research Committee
Address [1] 1533 0
Country [1] 1533 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3216 0
Ethics Committee in Bushehr University of Medical Science
Ethics committee address [1] 3216 0
Ethics committee country [1] 3216 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 3216 0
Approval date [1] 3216 0
27/02/2006
Ethics approval number [1] 3216 0
DP/20/18/3/2154

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

Contacts
Principal investigator
Name 27428 0
Address 27428 0
Country 27428 0
Phone 27428 0
Fax 27428 0
Email 27428 0
Contact person for public queries
Name 10683 0
Raha Pazoki
Address 10683 0
Bustan 9 (Morvarid) Alley
Imam Khomeini St.
Bushehr Postal Code 7514966768
Country 10683 0
Iran, Islamic Republic Of
Phone 10683 0
+98 771 2541828
Fax 10683 0
Email 10683 0
[email protected]
Contact person for scientific queries
Name 1611 0
Raha Pazoki
Address 1611 0
Research Deputy
The Persian Gulf Health Research Center
Bushehr University of Medical Science
Bushehr
Country 1611 0
Iran, Islamic Republic Of
Phone 1611 0
+98 771 2541828
Fax 1611 0
Email 1611 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.