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Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk

Willemijn AM van Gemert1*, Jolein I Iestra1, Albertine J Schuit23, Anne M May1, Tim Takken45, Wouter B Veldhuis6, Job van der Palen78, Harriët Wittink9, Petra HM Peeters1 and Evelyn M Monninkhof1

Author affiliations

1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500 Hp, Str. 6.131, 3508 GA, Utrecht, The Netherlands

2 Division of Public Health and Health Care, National Institute for Public Health and the Environment, P.O. Box 1 3720 BA, Bilthoven, The Netherlands

3 Department of Health Sciences and EMGO Institute for Health and Care Research, VU University, Amsterdam, The Netherlands

4 Shared Utrecht Pediatric Exercise Research (SUPER) Lab, Utrecht University, Utrecht, The Netherlands

5 Child Development & Exercise Center, Wilhelmina Children’s Hospital, University Medical Center Utrecht, P.O. Box 85500 Hp, Str. 6.131, 3508 GA, Utrecht, The Netherlands

6 Department of Radiology, University Medical Center, P.O. Box 85500 Hp, Str. 6.131, 3508 GA, Utrecht, The Netherlands

7 Medisch Spectrum Twente Hospital, Department of Epidemiology, P.O. Box 50 000 7500 KA, Enschede, The Netherlands

8 Department of Research Methodology, Measurement, and Data Analysis, University of Twente, Enschede, The Netherlands

9 Research group Lifestyle and Health, Faculty of Health Care, Utrecht University of Applied Sciences, P.O. Box 85182 3508 AD, Utrecht, The Netherlands

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Citation and License

BMC Cancer 2013, 13:395  doi:10.1186/1471-2407-13-395

Published: 23 August 2013



Physical inactivity and overweight are two known risk factors for postmenopausal breast cancer. Former exercise intervention studies showed that physical activity influences sex hormone levels, known to be related to postmenopausal breast cancer, mainly when concordant loss of body weight was achieved. The question remains whether there is an additional beneficial effect of physical activity when weight loss is reached.

The aim of this study is to investigate the effect attributable to exercise on postmenopausal breast cancer risk biomarkers, when equivalent weight loss is achieved compared with diet-induced weight loss.


The SHAPE-2 study is a three-armed, multicentre trial. 243 sedentary, postmenopausal women who are overweight or obese (BMI 25–35 kg/m2) are enrolled. After a 4-6 week run-in period, wherein a baseline diet is prescribed, women are randomly allocated to (1) a diet group, (2) an exercise group or (3) a control group. The aim of both intervention groups is to lose an amount of 5–6 kg body weight in 10–14 weeks. The diet group follows an energy restricted diet and maintains the habitual physical activity level. The exercise group participates in a 16-week endurance and strength training programme of 4 hours per week. Furthermore, they are prescribed a moderate caloric restriction. The control group is asked to maintain body weight and continue the run-in baseline diet.

Measurements include blood sampling, questionnaires, anthropometrics (weight, height, waist and hip circumference), maximal cycle exercise test (VO2peak), DEXA-scan (body composition) and abdominal MRI (subcutaneous and visceral fat). Primary outcomes are serum levels of oestradiol, oestrone, testosterone and sex hormone binding globulin (SHBG).


This study will give insight in the potential attributable effect of physical activity on breast cancer risk biomarkers and whether this effect is mediated by changes in body composition, in postmenopausal women. Eventually this may lead to the design of specific lifestyle guidelines for prevention of breast cancer.

Trial registration

The SHAPE-2 study is registered in the register of, Identifier: NCT01511276.