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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
Authors:Meike AQ Mutsaerts  Henk Groen  Nancy CW ter Bogt  Johanna HT Bolster  Jolande A Land  Wanda JE Bemelmans  Walter KH Kuchenbecker  Peter GA Hompes  Nick S Macklon  Ronald P Stolk  Fulco van der Veen  Jacques WM Maas  Nicole F Klijn  Eugenie M Kaaijk  Gerrit JE Oosterhuis  Peter XJM Bouckaert  Jaap M Schierbeek  Yvonne M van Kasteren  Annemiek W Nap  Frank J Broekmans  Egbert A Brinkhuis  Carolien AM Koks  Jan M Burggraaff  Adrienne S Blankhart  Denise AM Perquin  Marie H Gerards  Robert JAB Mulder  Ed TCM Gondrie  Ben WJ Mol  Annemieke Hoek
Affiliation: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
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
Keywords:
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