Promoting weight loss through diet and exercise in overweight women with breast cancer
- Conditions
- Overweight or obese breast cancer patientsCancer
- Registration Number
- ISRCTN53325751
- Lead Sponsor
- European Institute of Oncology (Italy)
- Brief Summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27464488
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 266
1. Women aged 18 or older
2. Written informed consent obtained
3. Willing to be randomized to either group
4. Histological breast cancer diagnosis
5. BMI comprised between 25 and 40 kg/m2
6. Within one year/6 months of completion of main cancer treatment
7. Willing to wear the wrist-based activity monitor during the 6-month study period
1. Unable to find transportation to the study location over the study period
2. Plan to move away from Lombardy or to be out of town for more than 3 weeks during the study period
3. Investigator does not approve participation in the study in case of:
3.1. History of heart condition, stroke, chest pain during activity or rest
3.2. Severe hypertension
3.3. Patient is unable to walk for exercise (self-report)
3.4. Symptoms of alcohol or substance dependence
3.5. Recent hip fracture, hip or knee replacement, spinal surgery or other orthopedic complications that would prevent optimal participation in the physical activities prescribed
4. Any other severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period
5. Participant already participates to a physical activity or diet intervention trial
6. Participant currently uses an activity monitor device
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body weight (weight loss =5% of the baseline body weight) at the end of the 6-month intervention
- Secondary Outcome Measures
Name Time Method