Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000198527
Ethics application status
Approved
Date submitted
3/05/2006
Date registered
26/05/2006
Date last updated
14/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight loss and exercise in PCOS Study 2006
Scientific title
Effects of exercise and lifestyle management on reproductive function in overweight women with polycystic ovary syndrome
Secondary ID [1] 285173 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1174 0
Polycystic ovary sydrome (PCOS) 1175 0
Condition category
Condition code
Diet and Nutrition 1258 1258 0 0
Obesity
Reproductive Health and Childbirth 1259 1259 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned for the 20 week intervention to either:

(2) energy restrictive diet (6000kj: carbohydrate 40% total energy, protein 30%, fat 30%) and aerobic exercise (45 to 60 minutes:5 times per week) or
(3) energy restrictive diet (6000kj: carbohydrate 40% total energy, protein 30%, fat 30%) and combined aerobic training (45-60 minutes: 3 times per week) and strength training (twice per week)
Intervention code [1] 1018 0
Lifestyle
Comparator / control treatment
(1) energy restrictive diet (6000kj: carbohydrate 40% total energy, protein 30%, fat 30%) only for 20 weeks.
Control group
Active

Outcomes
Primary outcome [1] 1696 0
Weight loss
Timepoint [1] 1696 0
At baseline and 10 and 20 weeks after start of lifestyle interventions
Primary outcome [2] 1697 0
Reproductive function
Timepoint [2] 1697 0
At baseline and 10 and 20 weeks after start of lifestyle interventions
Secondary outcome [1] 3039 0
Body composition,lipids,insulin sensitivity, and glucose.
Timepoint [1] 3039 0
At baseline and 10 and 20 weeks after start of lifestyle interventions
Secondary outcome [2] 309962 0
Quality of life assessed using PCOSQ
Timepoint [2] 309962 0
At baseline and 10 and 20 weeks after start of lifestyle interventions
Secondary outcome [3] 309963 0
Depression assessed using the Center for Epidemiological Studies-Depression scale
Timepoint [3] 309963 0
At baseline and 10 and 20 weeks after start of lifestyle interventions
Secondary outcome [4] 309964 0
Perceived benefits from exercise and barriers to exercise assessed using the Exercise Benefits/Barriers Scale
Timepoint [4] 309964 0
At baseline and 10 and 20 weeks after start of lifestyle interventions

Eligibility
Key inclusion criteria
Overweight or obese PCOS
Generally healthy with no chronic or acute diseases or disorders
Not pregnant or breast feeding.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Known cardiovascular disease, current smoking, diabetes mellitus uncontrolled hypertension, proteinuria, a malignancy, a history of liver, kidney or respiratory disease, or are pregnantUnrelated reproductive disorders. thyroid abnormalities (hypo- and hyperthyroidism), non-classic adrenal hyperplasia as assessed by fasting or acetylthiocholine (ATCH)-stimulated serum 17-hydroxyprogesterone).Fertility treatment such as clomiphene citrate or In-Vitro Fertilisation (IVF), insulin-sensitising agents (participation will be allowed upon discontinuation of therapy for one month prior to intervention).Oral contraceptive use (participation will be allowed upon discontinuation of oral contractive therapy one month prior to intervention). Participations will be required to use barrier contraception throughout the study intervention.

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
three lifestyle interventions
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
19/06/2006
Date of last participant enrolment
Anticipated
Actual
31/01/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1377 0
Government body
Name [1] 1377 0
national health & medical research council of Australia
Country [1] 1377 0
Australia
Primary sponsor type
Other
Name
CSIRO Human Nutrition
Address
CSIRO Human Nutrition
PO Box 10041 Adelaide BC SA 5000
Country
Australia
Secondary sponsor category [1] 1212 0
None
Name [1] 1212 0
nil
Address [1] 1212 0
Country [1] 1212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2730 0
CSIRO Human Nutrition
Ethics committee address [1] 2730 0
Ethics committee country [1] 2730 0
Australia
Date submitted for ethics approval [1] 2730 0
Approval date [1] 2730 0
08/12/2005
Ethics approval number [1] 2730 0
05/32

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

Contacts
Principal investigator
Name 36048 0
Dr Grant Brinkworth
Address 36048 0
CSIRO Human Nutrition PO Box 10041 Adelaide BC SA 5000
Country 36048 0
Australia
Phone 36048 0
+61 8 83038830
Fax 36048 0
Email 36048 0
[email protected]
Contact person for public queries
Name 10207 0
Grant Brinkworth
Address 10207 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10207 0
Australia
Phone 10207 0
+61 8 83038830
Fax 10207 0
+61 8 8303 8899
Email 10207 0
[email protected]
Contact person for scientific queries
Name 1135 0
Grant Brinkworth
Address 1135 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1135 0
Australia
Phone 1135 0
+61 8 83038830
Fax 1135 0
+61 8 8303 8899
Email 1135 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
SourceTitleYear of PublicationDOI
Dimensions AIThe effect of diet and exercise on markers of endothelial function in overweight and obese women with polycystic ovary syndrome2012https://doi.org/10.1093/humrep/des138
Dimensions AISeasonal effects on vitamin D status influence outcomes of lifestyle intervention in overweight and obese women with polycystic ovary syndrome2013https://doi.org/10.1016/j.fertnstert.2012.12.042
EmbasePerceived exercise barriers are reduced and benefits are improved with lifestyle modification in overweight and obese women with polycystic ovary syndrome: A randomised controlled trial.2016https://dx.doi.org/10.1186/s12905-016-0292-8
EmbasePredictors of lifestyle intervention attrition or weight loss success in women with polycystic ovary syndrome who are overweight or obese.2019https://dx.doi.org/10.3390/nu11030492
N.B. These documents automatically identified may not have been verified by the study sponsor.