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NCT Number: NCT02622711

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

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.

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Key information

Conditions

Breast Cancer Behavior Body Weight Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DI

Behavioral

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

PAI

Behavioral

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

PADI

Behavioral

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

LII

Behavioral

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

Primary outcomes

  1. Body weight reduction

    Time frame: baseline - 6 month

    weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

Secondary outcomes

  1. Long-term body weight control

    Time frame: baseline - 12 month - 24 month

    long-term weight control or maintenance via calibrated scales, stadiometer

  2. Pedometer Step Count

    Time frame: baseline - 6 month - 12 month - 24 month

    change in total step count via pedometer device with electronic data transmission

  3. Physical activity level

    Time frame: baseline - 6 month - 12 month - 24 month

    change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire

  4. Dietary intake

    Time frame: baseline - 6 month - 24 month

    change in dietary intake via Food Frequency Questionnaire

  5. Quality of life

    Time frame: baseline - 6 month - 12 month - 24 month

    change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)

  6. Mood

    Time frame: baseline - 6 month - 12 month - 24 month

    change in mood via State-Trait Anxiety Inventory (STAI) questionnaires

  7. Lipid Marker Change

    Time frame: baseline - 6 month - 24 month

    change in LDL, HDL, triglycerides and cholesterol assessed by blood samples

  8. Oestradiol level

    Time frame: baseline - 6 month - 24 month

    change in oestradiol assessed by blood samples

  9. Insulin level

    Time frame: baseline - 6 month - 24 month

    change in insulin assessed by blood samples

  10. Glucose level

    Time frame: baseline - 6 month - 24 month

    change in glucose assessed by blood samples

  11. C-reactive protein level

    Time frame: baseline - 6 month - 24 month

    change in C-reactive protein assessed by blood samples

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

Registry information

Official study title

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

Acronym: InForma

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2015
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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