Promoting weight loss through diet and exercise in overweight women with breast cancer: a four-arm randomized trial - InForma study

European Institute of Oncology (Italy)0 sites266 target enrollmentOctober 16, 2015

Overview

Registry

who.int

Start Date

October 16, 2015

End Date

June 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

European Institute of Oncology (Italy)

•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