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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 1377 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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
Adelaide, South Australia
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
Australia and other Western communities face an “epidemic of obesity” among its people, particularly in the young. The health problems of obesity include diabetes mellitus, hyperlipidemia, micro- and macrovascular disease, disability and early death. Major public health interventions are required in Australia to reverse this serious and expensive trend. This is particularly true in young overweight women with polycystic ovary syndrome (PCOS) who have significant psychological, reproductive and metabolic consequences during the first five decades of life. Although research indicates that weight loss via dietary restriction can restore health and reverse the reproductive and metabolic consequences of PCOS, there is a lack of scientific understanding of the combined role of physical exercise in managing this condition. Furthermore, there remains no attempt to define the optimal mode of exercise to achieve long-term reproductive fitness and metabolic health and consequently a lack of exercise recommendations for this population exists.

The overall significance of this research proposal is to provide scientific evidence for the effects of physical exercise combined with dietary weight loss to improve ovulatory rates and reproductive health in overweight women with PCOS. This study will also provide information on what, if any, is the most efficacious form of exercise for improving reproductive function in this patient group. This information will assist in the development and refinement of guidelines for managing PCOS through lifestyle behavioural change. Precise guidelines would be of great use for firstly improving conception rates through improvements in the metabolic state and secondly through minimising longer term diabetic and cardiovascular mortality and morbidity. Systematic study of the effects of exercise and variants of its modalities in combination with dietary change is imperative in order to make appropriate public health recommendation and to counsel individual patients.
Trial website
Trial related presentations / publications
Publications:
Thomson R, Buckley J, Lim SS, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Lifestyle management improves quality of life and depression in overweight and obese women with polycystic ovary syndrome’, Fertility and Sterility. 2010; 94: 1812-16.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Heart rate recovery improves after weight loss in overweight and obese women with polycystic ovary syndrome’, Fertility and Sterility. 2010; 93(4): 1173-1178.
Thomson R, Buckley J, Moran, L, Noakes M, Clifton P, Norman R, & Brinkworth G ‘The effect of weight loss on anti-m?llerian hormone levels in overweight and obese women with polycystic ovary syndrome and reproductive impairment’, Human Reproduction. 2009; 24(8): 1976-81.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile and reproductive function in overweight and obese women with polycystic ovary syndrome’, Journal of Clinical Endocrinology and Metabolism. 2008; 93(8): 3373-3380.

Presentations
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Effect of energy-restriction and exercise on quality of life and depression in overweight and obese women with polycystic ovary syndrome’ The Nutrition Society of Australia 33rd Annual Scientific Meeting. Newcastle, NSW, Dec 2009.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Effects of energy-restriction and exercise on cardiovascular risk profile and reproductive function in overweight and obese women with polycystic ovary syndrome’, Cardiovascular Research Forum. Adelaide, SA, Dec 2008.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Effect of a energy-restriction and exercise on body composition, cardiovascular risk profile and reproductive function in overweight and obese women with polycystic ovary syndrome’, Asia Pacific Journal of Clinical Nutrition. 2008; 17:S85.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Effect of a energy-restriction and exercise on body composition, cardiovascular risk profile and reproductive function in overweight and obese women with polycystic ovary syndrome’, The Australian and New Zealand Obesity Society Annual Scientific Meeting, Brisbane, QLD, Nov 2008.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘Effects of a hypocaloric diet with and without exercise training on body composition, metabolic risk profile and reproductive function in overweight and obese women with polycystic ovary syndrome’, Obesity. 2008; 16:S230.
Thomson R, Buckley J, Noakes M, Clifton P, Norman R, & Brinkworth G ‘The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile and reproductive function in overweight and obese women with polycystic ovary syndrome’, The Australian Society for Medical Research (SA Division) Annual Scientific Meeting, Adelaide, SA, June 2008.
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
grant.brinkworth@csiro.au
Contact person for public queries
Name 10207 0
Dr 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
grant.brinkworth@csiro.au
Contact person for scientific queries
Name 1135 0
Dr 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
grant.brinkworth@csiro.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary