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Open Access Study protocol

Design of the New Life(style) study: a randomised controlled trial to optimise maternal weight development during pregnancy. [ISRCTN85313483]

Ellen Althuizen1, Mireille NM van Poppel12*, Jacob C Seidell13, Carla van der Wijden14 and Willem van Mechelen12

Author Affiliations

1 Department of Public and Occupational Health, EMGO-Institute, VU University Medical Center, Amsterdam, The Netherlands

2 Research Center Physical Activity, Work and Health, TNO-VU, Amsterdam and Hoofddorp, The Netherlands

3 Department of Nutrition and Health, Faculty of Earth and Life Sciences, VU University Amsterdam, The Netherlands

4 Department of Obstetrics and Gyneacology, Medical Center Amstelland, Amstelveen, The Netherlands

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BMC Public Health 2006, 6:168  doi:10.1186/1471-2458-6-168

Published: 26 June 2006

Abstract

Background

Preventing excessive weight gain during pregnancy is potentially important in the prevention of overweight and obesity among women of childbearing age. However, few intervention studies aiming at weight management during pregnancy have been performed and most of these interventions were not as successful as expected. In this paper the design of the New Life(style) study is described as well as the content of the individually tailored intervention program, which focuses on controlling weight development during pregnancy.

Methods

The effectiveness of the New Life(style) intervention program versus usual care by midwives is evaluated in a randomised controlled trial. Women who expect their first child and visit one of the participating midwifery practices are included. The intervention is standardised in a protocol and executed by trained counsellors with the women who are randomised in the intervention group. During 5 sessions – at 18, 22, 30 and 36 weeks of pregnancy and at 8 weeks postpartum – individual weight gain is discussed in relation to weight gain guidelines for pregnant women of the American Institute of Medicine. Counsellors coach the women to maintain or optimise a healthy lifestyle, in a period of drastic physical and mental changes. Data is collected at 15, 25, 35 weeks of pregnancy and at 6, 26, and 52 weeks after delivery. Primary outcome measures are body weight, BMI, and skinfold thickness. Secondary outcome measures include physical activity, nutrition and blood levels of factors that are associated with energy homeostasis.

Discussion

Results of the current RCT will improve the knowledge of determinants of weight gain during pregnancy, weight retention after childbirth and of the effectiveness of the intervention program that is described. Caregivers and researchers in the field of health promotion are offered more insight in specific elements of the New Life(style) intervention program.