Open Access Study protocol

The LIFESTYLE study: costs and effects of a structured lifestyle program in overweight and obese subfertile women to reduce the need for fertility treatment and improve reproductive outcome. A randomised controlled trial

Meike AQ Mutsaerts1*, Henk Groen2, Nancy CW ter Bogt3, Johanna HT Bolster1, Jolande A Land1, Wanda JE Bemelmans4, Walter KH Kuchenbecker5, Peter GA Hompes6, Nick S Macklon7, Ronald P Stolk2, Fulco van der Veen8, Jacques WM Maas9, Nicole F Klijn10, Eugenie M Kaaijk11, Gerrit JE Oosterhuis12, Peter XJM Bouckaert13, Jaap M Schierbeek14, Yvonne M van Kasteren15, Annemiek W Nap16, Frank J Broekmans7, Egbert A Brinkhuis17, Carolien AM Koks18, Jan M Burggraaff19, Adrienne S Blankhart20, Denise AM Perquin21, Marie H Gerards22, Robert JAB Mulder23, Ed TCM Gondrie24, Ben WJ Mol25 and Annemieke Hoek1

Author Affiliations

1 Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

2 Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

3 Department of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

4 Centre for Prevention and Health Services Research, National Institute for Public Health and the Environment, Bilthoven, The Netherlands

5 Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands

6 Department of Obstetrics and Gynaecology, Free University Medical Center, Amsterdam, the Netherlands

7 Department of Obstetrics and Gynaecology, Utrecht Medical Center University, University of Utrecht, The Netherlands

8 Centre for Reproductive Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

9 Department of Obstetrics and Gynaecology, Maastricht University Medical Center, University of Maastricht, Maastricht, The Netherlands

10 Departement of Gynaecology and Reproductive Medicine, Leids University Medical Center, University of Leiden, Leiden, The Netherlands

11 Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

12 Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, The Netherlands

13 Department of Obstetrics and Gynaecology, Atrium Medical Center, Heerlen, The Netherlands

14 Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands

15 Department of Obstetrics and Gynaecology, Medical Center Alkmaar, Alkmaar, The Netherlands

16 Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands

17 Department of Obstetrics and Gynaecology, Meander Medical Center, Amersfoort, The Netherlands

18 Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands

19 Department of Obstetrics and Gynaecology, Leveste Hospital, Emmen, The Netherlands

20 Department of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, The Netherlands

21 Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, The Netherlands

22 Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, The Netherlands

23 Department of Obstetrics and Gynaecology, Laurentius Hospital, Roermond, The Netherlands

24 Department of Obstetrics and Gynaecology, Orbis Medical Center, Sittard, The Netherlands

25 Department of Obstetrics and Gynaecology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

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BMC Women's Health 2010, 10:22  doi:10.1186/1472-6874-10-22

Published: 25 June 2010

Abstract

Background

In the Netherlands, 30% of subfertile women are overweight or obese, and at present there is no agreement on fertility care for them. Data from observational and small intervention studies suggest that reduction of weight will increase the chances of conception, decrease pregnancy complications and improve perinatal outcome, but this has not been confirmed in randomised controlled trials. This study will assess the cost and effects of a six-months structured lifestyle program aiming at weight reduction followed by conventional fertility care (intervention group) as compared to conventional fertility care only (control group) in overweight and obese subfertile women. We hypothesize that the intervention will decrease the need for fertility treatment, diminish overweight-related pregnancy complications, and will improve perinatal outcome.

Methods/Design

Multicenter randomised controlled trial in subfertile women (age 18-39 year) with a body mass index between 29 and 40 kg/m2. Exclusion criteria are azoospermia, use of donor semen, severe endometriosis, premature ovarian failure, endocrinopathies or pre-existent hypertensive disorders.

In the intervention group the aim is a weight loss of at least 5% to10% in a six-month period, to be achieved by the combination of a diet, increase of physical activity and behavioural modification. After six months, in case no conception has been achieved, these patients will start fertility treatment according to the Dutch fertility guidelines. In the control group treatment will be started according to Dutch fertility guidelines, independently of the patient's weight.

Outcome measures and analysis

The primary outcome measure is a healthy singleton born after at least 37 weeks of gestation after vaginal delivery. Secondary outcome parameters including pregnancy outcome and complications, percentage of women needing fertility treatment, clinical and ongoing pregnancy rates, body weight, quality of life and costs.

Data will be analysed according to the intention to treat principle, and cost-effectiveness analysis will be performed to compare the costs and health effects in the intervention and control group.

Discussion

The trial will provide evidence for costs and effects of a lifestyle intervention aiming at weight reduction in overweight and obese subfertile women and will offer guidance to clinicians for the treatment of these patients.

Trial registration

Dutch Trial Register NTR1530