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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Polycystic ovary sydrome (PCOS)

Condition category

Condition code

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

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]

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]

Weight loss

Timepoint [1]

At baseline and 10 and 20 weeks after start of lifestyle interventions

Primary outcome [2]

Reproductive function

Timepoint [2]

At baseline and 10 and 20 weeks after start of lifestyle interventions

Secondary outcome [1]

Body composition,lipids,insulin sensitivity, and glucose.

Timepoint [1]

At baseline and 10 and 20 weeks after start of lifestyle interventions

Secondary outcome [2]

Quality of life assessed using PCOSQ

Timepoint [2]

At baseline and 10 and 20 weeks after start of lifestyle interventions

Secondary outcome [3]

Depression assessed using the Center for Epidemiological Studies-Depression scale

Timepoint [3]

At baseline and 10 and 20 weeks after start of lifestyle interventions

Secondary outcome [4]

Perceived benefits from exercise and barriers to exercise assessed using the Exercise Benefits/Barriers Scale

Timepoint [4]

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]

Government body

Name [1]

national health & medical research council of Australia

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CSIRO Human Nutrition

Ethics committee address [1]

Adelaide, South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/12/2005

Ethics approval number [1]

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

Dr Grant Brinkworth

Address

CSIRO Human Nutrition PO Box 10041 Adelaide BC SA 5000

Country

Australia

Phone

+61 8 83038830

Fax

Email

[email protected]

Contact person for public queries

Name

Grant Brinkworth

Address

CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000

Country

Australia

Phone

+61 8 83038830

Fax

+61 8 8303 8899

Email

[email protected]

Contact person for scientific queries

Name

Grant Brinkworth

Address

CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000

Country

Australia

Phone

+61 8 83038830

Fax

+61 8 8303 8899

Email

[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

Source	Title	Year of Publication	DOI
Dimensions AI	The effect of diet and exercise on markers of endothelial function in overweight and obese women with polycystic ovary syndrome	2012	https://doi.org/10.1093/humrep/des138
Dimensions AI	Seasonal effects on vitamin D status influence outcomes of lifestyle intervention in overweight and obese women with polycystic ovary syndrome	2013	https://doi.org/10.1016/j.fertnstert.2012.12.042
Embase	Perceived exercise barriers are reduced and benefits are improved with lifestyle modification in overweight and obese women with polycystic ovary syndrome: A randomised controlled trial.	2016	https://dx.doi.org/10.1186/s12905-016-0292-8
Embase	Predictors of lifestyle intervention attrition or weight loss success in women with polycystic ovary syndrome who are overweight or obese.	2019	https://dx.doi.org/10.3390/nu11030492

N.B. These documents automatically identified may not have been verified by the study sponsor.