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

May 2, 2017 updated by: E.M. Monninkhof, UMC Utrecht

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk Biomarkers in Postmenopausal Women: the SHAPE-2 Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postmenopausal women who are sedentary or overweight, have an increased breast cancer risk. It is suggested that these two factors mediate breast cancer risk mainly through sex hormone-related pathways. However, an inactive lifestyle and obesity are highly correlated and it is not clear which is most relevant to risk.

Literature shows that weight loss/ fat loss reduces postmenopausal sex hormone levels, but the question is if there is an additional beneficial effect on hormones of reaching this weight loss by physical activity instead of nutritional interventions.

In this three-armed, two-center intervention study, 250 sedentary postmenopausal women who are aged 50-69 years will first enter a run-in period of 5 weeks. During this period, all participants get a diet, adapted to the guidelines for healthy nutrition, meeting their energy expenditures to maintain stable weight. After this run-in phase they are randomly allocated to a (1) diet induced weight loss group, (2) a combined exercise and diet induced weight loss group or (3) a control group. Participants allocated to the dietgroup will get a calorie restricted diet of -500 kCal/day, they will remain their habitual exercise pattern. Participants in the combined group will follow an exercise programme (combined endurance and strength) of 4 hours of sports per week with an average energy expenditure of 350 kCal/day and a, less strict. And a calorie restricted diet of -250 kCal/day. The aim of both intervention groups is to loose 5-6 kg of body weight during the 14 week intervention period. Participants in the control group are requested to retain the baseline diet and their habitual exercise pattern. Primary study parameters measured at baseline and after 21 weeks are: serum concentrations of endogenous estrogens, endogenous androgens and sex hormone binding globulin. Other study parameters include: body fat distribution, amount of total and abdominal fat, weight, BMI, physical fitness, blood pressure and lifestyle factors.

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. Furthermore, we are specifically interested whether weight loss mainly due to physical exercise induces greater amounts of fat loss (total and abdominal) and subsequently results in more favourable effects on these hormones compared to equivalent diet-induced weight loss.

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7500 KA
        • Medisch Spectrum Twente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • 50-69 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet-induced weight loss
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
Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.
Experimental: Mainly exercise induced weight loss

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

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.
No Intervention: Control, stable weight
The control group is asked to follow a baseline isocaloric diet and to not change their habitual sedentary lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum sex hormone levels
Time Frame: 21 weeks
Estradiol (total, free), estrone, testosterone, sex hormone binding globulin.
21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometrics and physical fitness.
Time Frame: 21 weeks
BMI, weight, waist- and hip-circumference, total body fat (DEXA scan), abdominal fat (subcutaneous and visceral, MRI-abdomen) and physical fitness (maximal exercise capacity test by the ramp protocol).
21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: evelyn Monninkhof, PhD, UMC Utrecht, Julius Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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