Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 262
- Locations
- 2
- Primary Endpoint
- Body weight reduction
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Body weight reduction
Time Frame: baseline - 6 month
weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer
Secondary Outcomes
- Pedometer Step Count(baseline - 6 month - 12 month - 24 month)
- Oestradiol level(baseline - 6 month - 24 month)
- Physical activity level(baseline - 6 month - 12 month - 24 month)
- Long-term body weight control(baseline - 12 month - 24 month)
- Quality of life(baseline - 6 month - 12 month - 24 month)
- Mood(baseline - 6 month - 12 month - 24 month)
- Dietary intake(baseline - 6 month - 24 month)
- Lipid Marker Change(baseline - 6 month - 24 month)
- Insulin level(baseline - 6 month - 24 month)
- Glucose level(baseline - 6 month - 24 month)
- C-reactive protein level(baseline - 6 month - 24 month)