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

Willemijn A.M. van Gemert, Jolein I. Iestra, Albertine J. Schuit, Anne M. May, Tim Takken, Wouter B. Veldhuis, Job van der Palen, Harriet Wittink, Petra H.M. Peeters, Evelyn M. Monninkhof

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Abstract

Background: 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.

Design: 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).

Discussion: 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
Original languageEnglish
Article number395
Number of pages10
JournalBMC cancer
Volume13
Issue number1
DOIs
Publication statusPublished - 2013

Fingerprint

Weight Loss
Biomarkers
Exercise
Breast Neoplasms
Diet
Body Weight
Tumor Biomarkers
Body Composition
Abdominal Subcutaneous Fat
Reducing Diet
Caloric Restriction
Sex Hormone-Binding Globulin
Control Groups
Resistance Training
Intra-Abdominal Fat
Estrone
Photon Absorptiometry
Gonadal Steroid Hormones
Waist Circumference
Exercise Test

Keywords

  • METIS-301182
  • IR-88748

Cite this

van Gemert, W. A. M., Iestra, J. I., Schuit, A. J., May, A. M., Takken, T., Veldhuis, W. B., ... Monninkhof, E. M. (2013). Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk. BMC cancer, 13(1), [395]. https://doi.org/10.1186/1471-2407-13-395
van Gemert, Willemijn A.M. ; Iestra, Jolein I. ; Schuit, Albertine J. ; May, Anne M. ; Takken, Tim ; Veldhuis, Wouter B. ; van der Palen, Job ; Wittink, Harriet ; Peeters, Petra H.M. ; Monninkhof, Evelyn M. / Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk. In: BMC cancer. 2013 ; Vol. 13, No. 1.
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abstract = "Background: 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. Design: 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).Discussion: 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",
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van Gemert, WAM, Iestra, JI, Schuit, AJ, May, AM, Takken, T, Veldhuis, WB, van der Palen, J, Wittink, H, Peeters, PHM & Monninkhof, EM 2013, 'Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk' BMC cancer, vol. 13, no. 1, 395. https://doi.org/10.1186/1471-2407-13-395

Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk. / van Gemert, Willemijn A.M.; Iestra, Jolein I.; Schuit, Albertine J.; May, Anne M.; Takken, Tim; Veldhuis, Wouter B.; van der Palen, Job; Wittink, Harriet; Peeters, Petra H.M.; Monninkhof, Evelyn M.

In: BMC cancer, Vol. 13, No. 1, 395, 2013.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk

AU - van Gemert, Willemijn A.M.

AU - Iestra, Jolein I.

AU - Schuit, Albertine J.

AU - May, Anne M.

AU - Takken, Tim

AU - Veldhuis, Wouter B.

AU - van der Palen, Job

AU - Wittink, Harriet

AU - Peeters, Petra H.M.

AU - Monninkhof, Evelyn M.

N1 - Open access

PY - 2013

Y1 - 2013

N2 - Background: 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. Design: 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).Discussion: 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

AB - Background: 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. Design: 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).Discussion: 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

KW - METIS-301182

KW - IR-88748

U2 - 10.1186/1471-2407-13-395

DO - 10.1186/1471-2407-13-395

M3 - Article

VL - 13

JO - BMC cancer

JF - BMC cancer

SN - 1471-2407

IS - 1

M1 - 395

ER -