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

BMC Women's Health

Study Protocol

Wanda JE Bemelmans¹  Fulco van der Veen²  Nicole F Klijn³  Ronald P Stolk⁴  Henk Groen⁴  Nancy CW ter Bogt⁵  Ben WJ Mol⁶  Adrienne S Blankhart⁷  Peter XJM Bouckaert⁸  Jaap M Schierbeek⁹  Peter GA Hompes^1,10  Walter KH Kuchenbecker^1,11  Robert JAB Mulder^1,12  Jan M Burggraaff^1,13  Jacques WM Maas^1,14  Marie H Gerards^1,15  Carolien AM Koks^1,16  Egbert A Brinkhuis^1,17  Yvonne M van Kasteren^1,18  Denise AM Perquin^1,19  Gerrit JE Oosterhuis^2,20  Eugenie M Kaaijk^2,21  Ed TCM Gondrie^2,22  Annemiek W Nap^2,23  Frank J Broekmans^2,24  Nick S Macklon^2,24  Annemieke Hoek^2,25  Meike AQ Mutsaerts^2,25  Johanna HT Bolster^2,25  Jolande A Land^2,25 

[1] Centre for Prevention and Health Services Research, National Institute for Public Health and the Environment, Bilthoven, The Netherlands;Centre for Reproductive Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Departement of Gynaecology and Reproductive Medicine, Leids University Medical Center, University of Leiden, Leiden, The Netherlands;Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands;Department of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, The Netherlands;Department of Obstetrics and Gynaecology, Atrium Medical Center, Heerlen, The Netherlands;Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands;Department of Obstetrics and Gynaecology, Free University Medical Center, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands;Department of Obstetrics and Gynaecology, Laurentius Hospital, Roermond, The Netherlands;Department of Obstetrics and Gynaecology, Leveste Hospital, Emmen, The Netherlands;Department of Obstetrics and Gynaecology, Maastricht University Medical Center, University of Maastricht, Maastricht, The Netherlands;Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands;Department of Obstetrics and Gynaecology, Meander Medical Center, Amersfoort, The Netherlands;Department of Obstetrics and Gynaecology, Medical Center Alkmaar, Alkmaar, The Netherlands;Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, The Netherlands;Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, The Netherlands;Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Orbis Medical Center, Sittard, The Netherlands;Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands;Department of Obstetrics and Gynaecology, Utrecht Medical Center University, University of Utrecht, Utrecht, The Netherlands;Department of Obstetrics and Gynaecology,, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands;

关键词: Vaginal Delivery;    Lifestyle Intervention;    Perinatal Outcome;    Premature Ovarian Failure;    Fertility Treatment;   

DOI  :  10.1186/1472-6874-10-22

 received in 2010-03-29, accepted in 2010-06-25,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundIn 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/DesignMulticenter 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 analysisThe 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.DiscussionThe 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 registrationDutch Trial Register NTR1530

【 授权许可】

CC BY   
© Mutsaerts et al; licensee BioMed Central Ltd. 2010