NCT01511276

Brief Summary

Physical inactivity and overweight are two accepted risk factors for breast cancer. However, because of their correlation it is not clear which is most relevant to risk. The investigators now set out to study whether physical activity in addition to weight loss by diet only, affects sex hormone levels, known to be related to breast cancer risk. In the SHAPE-2 study 250 healthy overweight/obese and physically inactive women are randomly allocated to a diet-induced weight loss group, a combined exercise- and diet-induced weight loss group or a control group. The aim of the first two intervention groups is to loose 5-6 kg of bodyweight, either by dieting or mainly by increased physical activity. Measurements are performed at baseline and after 21 weeks, the end of the study period. The aim of this study is to provide insight into the effect of weight loss mainly driven by exercise compared to equivalent weight loss due to nutritional calorie restriction on breast cancer biomarkers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

January 12, 2012

Last Update Submit

May 2, 2017

Conditions

Breast Cancer Risk

Keywords

Breast cancerSex hormonesPhysical activity

Outcome Measures

Primary Outcomes (1)

  • serum sex hormone levels

    Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.

    21 weeks

Secondary Outcomes (1)

  • anthropometrics and physical fitness.

    21 weeks

Study Arms (3)

Diet-induced weight loss

EXPERIMENTAL

The diet-induced weight loss group will follow a calorie restricted diet. They are asked to keep their habitual sedentary lifestyle. The aim of this group is to loose 5-6 kg of body weight in 14 weeks time.

Behavioral: Diet

Mainly exercise induced weight loss

EXPERIMENTAL

Participants in the exercise- plus diet-induced weight loss group are enrolled in an exercise programme. Next to the exercise programme, they will follow a calorie restricted diet. The aim of this group is to loose 5-6 kg of body weight in 14 weeks time.

Behavioral: Mainly exercise induced weight loss

Control, stable weight

NO INTERVENTION

The control group is asked to follow a baseline isocaloric diet and to not change their habitual sedentary lifestyle.

Interventions

DietBEHAVIORAL

Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.

Diet-induced weight loss
Mainly exercise induced weight lossBEHAVIORAL

Exercise programme of 2 hours per week fitness containing endurance and resistance training. And 2 hours of Nordic Walking. Equivalent to an energy expenditure of 350 kCal/day. Next to the exercise programme participants will follow an energy restricted diet according to the national guidelines of healthy nutrition creating an extra energy deficit of 250 kCal/day.

Mainly exercise induced weight loss

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • years of age
  • Postmenopausal (\>12 months after last menses)
  • BMI 25-35 kg/m2
  • Sedentary (\<2 hours per week of at least moderately intensive activities (\>4 MET))
  • Willing to be randomly assigned to one of the three study arms
  • Informed consent to participate in all screening and study activities.

You may not qualify if:

  • Presently using sex-hormones
  • Maintenance use of corticosteroids
  • Suffering cancer (in medical history) except for non-melanoma skin cancers
  • Suffering type II diabetes mellitus or other endocrine related diseases
  • Smoking
  • Alcohol or drug abuse
  • Any disorder that might impede participation in the exercise programme
  • Following, or the intention to follow, a structured weight loss programme elsewhere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medisch Spectrum Twente

Enschede, Overijssel, 7500 KA, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (6)

  • van Gemert WA, Iestra JI, Schuit AJ, May AM, Takken T, Veldhuis WB, van der Palen J, Wittink H, Peeters PH, Monninkhof EM. 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. 2013 Aug 23;13:395. doi: 10.1186/1471-2407-13-395.

    PMID: 23972905BACKGROUND

  • van Gemert WA, van der Palen J, Monninkhof EM, Rozeboom A, Peters R, Wittink H, Schuit AJ, Peeters PH. Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial. PLoS One. 2015 Jun 1;10(6):e0127520. doi: 10.1371/journal.pone.0127520. eCollection 2015.

    PMID: 26029921RESULT

  • van Gemert WA, Schuit AJ, van der Palen J, May AM, Iestra JA, Wittink H, Peeters PH, Monninkhof EM. Effect of weight loss, with or without exercise, on body composition and sex hormones in postmenopausal women: the SHAPE-2 trial. Breast Cancer Res. 2015 Sep 2;17(1):120. doi: 10.1186/s13058-015-0633-9.

    PMID: 26330303RESULT

  • van Gemert WA, May AM, Schuit AJ, Oosterhof BY, Peeters PH, Monninkhof EM. Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women: The SHAPE-2 Trial, A Randomized Controlled Trial. Cancer Epidemiol Biomarkers Prev. 2016 May;25(5):799-806. doi: 10.1158/1055-9965.EPI-15-1065. Epub 2016 Feb 16.

    PMID: 26908432RESULT

  • de Roon M, van Gemert WA, Peeters PH, Schuit AJ, Monninkhof EM. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women: A randomized trial. Prev Med Rep. 2016 Dec 9;5:118-123. doi: 10.1016/j.pmedr.2016.12.006. eCollection 2017 Mar.

    PMID: 27981025RESULT

  • van Gemert WA, Peeters PH, May AM, Doornbos AJH, Elias SG, van der Palen J, Veldhuis W, Stapper M, Schuit JA, Monninkhof EM. Effect of diet with or without exercise on abdominal fat in postmenopausal women - a randomised trial. BMC Public Health. 2019 Feb 11;19(1):174. doi: 10.1186/s12889-019-6510-1.

    PMID: 30744621DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • evelyn Monninkhof, PhD

    UMC Utrecht, Julius Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Analyses of the blood assays and MRI data were masked.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 18, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2013

Study Completion

October 1, 2014

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

NL(2)