Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000680864
Ethics application status
Approved
Date submitted
21/06/2012
Date registered
25/06/2012
Date last updated
25/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of lifestyle modifications in polycystic ovarian syndrome
Scientific title
In women with PCOS (polycystic ovarian syndrome), is lifestyle counseling more effective than standard care in restoring menstruation?
Secondary ID [1] 280719 0
Nil
Universal Trial Number (UTN)
U1111-1132-0142
Trial acronym
PCOS-Lifestyle study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic ovarian syndrome 286761 0
Condition category
Condition code
Metabolic and Endocrine 287084 287084 0 0
Other metabolic disorders
Reproductive Health and Childbirth 287090 287090 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lifestyle counseling by physician in routine clinic visits.
Counseling conducted on
1. Dietary modification
2. Increasing physical activity
3. Locally available resources

Additional referrals as needed to a dietician.

Approximate duration: 5 - 15 minutes
Repeated every 3 months for 6 months.
Intervention code [1] 285138 0
Lifestyle
Comparator / control treatment
Standard care (without lifestyle counseling).

Routine assessment by physician including physical examination and laboratory testing. Discussion of disease diagnosis and treatment options.
Routine clinic follow-up every 3 months.
Control group
Active

Outcomes
Primary outcome [1] 287395 0
Restoration of regular menstruation as reported by the subject (cyclical monthly periods).
Timepoint [1] 287395 0
6 months after enrollment.
Secondary outcome [1] 298083 0
Weight [kg]
Timepoint [1] 298083 0
At 3 and 6 months after enrollment.
Secondary outcome [2] 298084 0
Waist circumference [cm]
Timepoint [2] 298084 0
At 3 and 6 months after enrollment.
Secondary outcome [3] 298085 0
Fasting blood glucose
Timepoint [3] 298085 0
At 3 and 6 months after enrollment.
Secondary outcome [4] 298086 0
Total cholesterol
Timepoint [4] 298086 0
At 3 and 6 months after enrollment.

Eligibility
Key inclusion criteria
1. Female gender
2. Age more than 16 years
3. Clinical diagnosis of polycystic ovarian syndrome (PCOS) with or without ultrasound or biochemical assessment
Minimum age
16 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Diabetes mellitus
3. Severe co-morbid medical conditions such as heart failure, organ transplant
4. Apparent visual, hearing or mental impairment

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)
Random allocation of subjects to intervention (individualized counseling) and control (standard care) groups will be carried out using pre-prepared, serially-numbered, opaque envelopes containing a card indicating either “Intervention” or “Control”. The clinician enrolling a patient will pick the next numbered envelope from the top the stack to determine allocation and record this in the case reporting form (CRF). The envelopes will be prepared by JH who will not be involved in subject enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence for cards will be computer generated with an appropriate block size to ensure balanced allocation in the two groups. Stratification will not be conducted unless a blinded interim analysis reveals unbalanced distributions of an important confounding factor such as the body mass index (BMI).
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4376 0
United Arab Emirates
State/province [1] 4376 0
Al Ain, Abu Dhabi

Funding & Sponsors
Funding source category [1] 285491 0
Hospital
Name [1] 285491 0
Tawam Hospital
Country [1] 285491 0
United Arab Emirates
Primary sponsor type
Hospital
Name
Tawam Hospital
Address
P.O. Box 15258, Al Ain
United Arab Emirates
Country
United Arab Emirates
Secondary sponsor category [1] 284338 0
University
Name [1] 284338 0
UAE University
Address [1] 284338 0
Faculty of Medicine and Health Sciences
PO Box 17666
Al Ain
Country [1] 284338 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287513 0
AL AIN MEDICAL DISTRICT HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 287513 0
Dr. Satish Chandra Nair
Tawam Hospital
P.O.Box 15258
Al Ain
Ethics committee country [1] 287513 0
United Arab Emirates
Date submitted for ethics approval [1] 287513 0
Approval date [1] 287513 0
29/05/2012
Ethics approval number [1] 287513 0
HREC 12/44 IRR# CRD 162 ICD10E28.2 Randomized Trial(PIT)

Summary
Brief summary
Women who have been diagnosed with polycystic ovarian syndrome will be divided into two groups: one group will receive lifestyle advice (diet and exercise) in addition to routine medical care. The other group will receive routine medical care only. The effect on menstrual cycle will be measured after 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34351 0
Address 34351 0
Country 34351 0
Phone 34351 0
Fax 34351 0
Email 34351 0
Contact person for public queries
Name 17598 0
Dr R Qureshi
Address 17598 0
Neima Clinic
affiliated with Tawam Hospital
P.O.Box 15258
Al Ain
Country 17598 0
United Arab Emirates
Phone 17598 0
+971 3 7137 409
Fax 17598 0
Email 17598 0
[email protected]
Contact person for scientific queries
Name 8526 0
Dr M Jawad Hashim
Address 8526 0
P O Box 17666
Department of Family Medicine
Faculty of Medicine and Health Sciences
UAE University
Al Ain
Country 8526 0
United Arab Emirates
Phone 8526 0
+971 3 7137 409
Fax 8526 0
Email 8526 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.