Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Overweight

Breast Neoplasms

Obesity

Body Weight

Weight Loss

Breast Diseases

Skin Diseases

Overnutrition

Nutrition Disorders

Body Weight Changes

Individualized dietary counselling to reduce body weight

Individualized physical activity counseling to reduce body weight

Individualized dietary and physical activity counseling to reduce body weight

Materials and guidelines available to general public

Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.

PADI

Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Patrick Maisonneuve

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer

Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial

weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

long-term weight control or maintenance via calibrated scales, stadiometer

change in total step count via pedometer device with electronic data transmission

change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire

change in dietary intake via Food Frequency Questionnaire

change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)

change in mood via State-Trait Anxiety Inventory (STAI) questionnaires

change in LDL, HDL, triglycerides and cholesterol assessed by blood samples

change in oestradiol assessed by blood samples

change in insulin assessed by blood samples

change in glucose assessed by blood samples

change in C-reactive protein assessed by blood samples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer	NCT02622711	Breast Cancer	DI PAI PADI LII	18 Years -	European Institute of Oncology

Spots Global Cancer Trial Database for padi

Every month we try and update this database with for padi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for padi

Every month we try and update this database with for padi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for padi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.