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

E

European Institute of Oncology

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: LII
Behavioral: PADI
Behavioral: PAI
Behavioral: DI

Study type

Interventional

Funder types

Other

Identifiers

NCT02622711
IEO 0244

Details and patient eligibility

About

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.

Full 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.

Enrollment

262 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

262 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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