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The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk (SHAPE-2)

NCT01511276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2017-05-05

No results posted yet for this study

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.

Conditions

  • Breast Cancer Risk

Interventions

BEHAVIORAL

Diet

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

BEHAVIORAL

Mainly exercise induced weight loss

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.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • evelyn Monninkhof, PhD · UMC Utrecht, Julius Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2014-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511276 on ClinicalTrials.gov