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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: DI
* Behavioral: PAI
* Behavioral: PADI
* Behavioral: LII


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with a first invasive non-metastatic breast carcinoma histologically confirmed, BMI > 25, within 6-month/one year of completion of main cancer treatment, being able to participate in the intervention, agree to wear the wrist-based activity monitor during the study period, agree to be randomized to either group, written informed consent. Exclusion Criteria: severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period, contraindications to exercise due to history of heart condition, stroke, chest pain during activity or rest, severe hypertension orthopaedic disability that would prevent optimal participation in the physical activities prescribed, patient is unable to find transportation to the study location over the study period, - or plans to move away from Lombardy or to be out of town for more than 3 weeks during the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DI Dietary Intervention<br>Individualized dietary counselling to reduce body weight | Behavioral: DI<br>* 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.<br>* Other names: Dietary Intervention;|
| Experimental: PAI Physical Activity Intervention<br>Individualized physical activity counseling to reduce body weight | Behavioral: PAI<br>* 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.<br>* Other names: Physical Activity Intervention;|
| Experimental: PADI Physical Activity+Diet Intervention<br>Individualized dietary and physical activity counseling to reduce body weight | Behavioral: PADI<br>* 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.<br>* Other names: Physical Activity and Dietary Intervention;|
| Experimental: LII Less Intensive Intervention<br>Materials and guidelines available to general public | Behavioral: LII<br>* Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.<br>* Other names: Less Intensive Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight reduction | weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer | baseline - 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term body weight control | long-term weight control or maintenance via calibrated scales, stadiometer | baseline - 12 month - 24 month | 
| Pedometer Step Count | change in total step count via pedometer device with electronic data transmission | baseline - 6 month - 12 month - 24 month | 
| Physical activity level | change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire | baseline - 6 month - 12 month - 24 month | 
| Dietary intake | change in dietary intake via Food Frequency Questionnaire | baseline - 6 month - 24 month | 
| Quality of life | change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B) | baseline - 6 month - 12 month - 24 month | 
| Mood | change in mood via State-Trait Anxiety Inventory (STAI) questionnaires | baseline - 6 month - 12 month - 24 month | 
| Lipid Marker Change | change in LDL, HDL, triglycerides and cholesterol assessed by blood samples | baseline - 6 month - 24 month | 
| Oestradiol level | change in oestradiol assessed by blood samples | baseline - 6 month - 24 month | 
| Insulin level | change in insulin assessed by blood samples | baseline - 6 month - 24 month | 
| Glucose level | change in glucose assessed by blood samples | baseline - 6 month - 24 month | 
| C-reactive protein level | change in C-reactive protein assessed by blood samples | baseline - 6 month - 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, obesity, weight control, exercise and physical fitness