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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: DI; Behavioral: PAI; Behavioral: PADI; Behavioral: LII

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 Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20141
    • IEO Istituto Europeo di Oncologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Collaborators: Associazione Italiana per la Ricerca sul Cancro
• Investigators: Principal Investigator: Patrick Maisonneuve, European Institue of Oncology

Publications and helpful links

General Publications

• Gnagnarella P, Draga D, Baggi F, Simoncini MC, Sabbatini A, Mazzocco K, Bassi FD, Pravettoni G, Maisonneuve P. Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. Trials. 2016 Jul 28;17:363. doi: 10.1186/s13063-016-1487-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (ESTIMATE): December 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; obesity; weight control; exercise and physical fitness
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss; Overweight
• Other Study ID Numbers: IEO 0244