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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: DI; Behavioral: PADI; Behavioral: LII; Behavioral: PAI

• Registration Number: NCT02622711
• Lead Sponsor: European Institute of Oncology

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 262

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DI Dietary Intervention	DI	Individualized dietary counselling to reduce body weight
PADI Physical Activity+Diet Intervention	PADI	Individualized dietary and physical activity counseling to reduce body weight
LII Less Intensive Intervention	LII	Materials and guidelines available to general public
PAI Physical Activity Intervention	PAI	Individualized physical activity counseling to reduce body weight

Primary Outcome Measures

Name	Time	Method
Body weight reduction	baseline - 6 month	weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IEO Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy