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Breast CancerInFormaNCT02622711

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

A study testing DI, PAI and PADI in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
DI, PAI and PADI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteItaly
Study dates
Nov 2015to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
DI, PAI, PADI, LII
Keywords
breast cancer, obesity, weight control, exercise and physical fitness
Medical subject headings
Breast Neoplasms, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DIBehavioural

    Also called Dietary Intervention

    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.

  • PAIBehavioural

    Also called Physical Activity Intervention

    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.

  • PADIBehavioural

    Also called Physical Activity and Dietary Intervention

    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.

  • LIIBehavioural

    Also called Less Intensive Intervention

    Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.

Study groups in NCT02622711
Study groupRoleWhat they receive
DI Dietary InterventionExperimentalIndividualized dietary counselling to reduce body weight
Receives: Behavioral: DI
PAI Physical Activity InterventionExperimentalIndividualized physical activity counseling to reduce body weight
Receives: Behavioral: PAI
PADI Physical Activity+Diet InterventionExperimentalIndividualized dietary and physical activity counseling to reduce body weight
Receives: Behavioral: PADI
LII Less Intensive InterventionExperimentalMaterials and guidelines available to general public
Receives: Behavioral: LII

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight reduction

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

    Measured: baseline - 6 month

Secondary outcomes (11)

  1. Long-term body weight control

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

    Measured: baseline - 12 month - 24 month

  2. Pedometer Step Count

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

    Measured: baseline - 6 month - 12 month - 24 month

  3. Physical activity level

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

    Measured: baseline - 6 month - 12 month - 24 month

  4. Dietary intake

    change in dietary intake via Food Frequency Questionnaire

    Measured: baseline - 6 month - 24 month

  5. Quality of life

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

    Measured: baseline - 6 month - 12 month - 24 month

  6. Mood

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

    Measured: baseline - 6 month - 12 month - 24 month

  7. Lipid Marker Change

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

    Measured: baseline - 6 month - 24 month

  8. Oestradiol level

    change in oestradiol assessed by blood samples

    Measured: baseline - 6 month - 24 month

  9. Insulin level

    change in insulin assessed by blood samples

    Measured: baseline - 6 month - 24 month

  10. Glucose level

    change in glucose assessed by blood samples

    Measured: baseline - 6 month - 24 month

  11. C-reactive protein level

    change in C-reactive protein assessed by blood samples

    Measured: baseline - 6 month - 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02622711
Sponsor's protocol ID
IEO 0244
Acronym
InForma
Status last verified
Jan 2020
First submitted
6 Nov 2015
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Gnagnarella P, Carioni G, Draga D, Raja S, Baggi F, Simoncini MC, Mazzocco K, Masiero M, Bassi FD, Peradze N, Zorzino L, Pravettoni G, Sieri S, Maisonneuve P. Dietary patterns and change in food consumption in overweight or obese breast cancer survivors: the InForma randomized intervention trial. Nutr Metab Cardiovasc Dis. 2026 Feb;36(2):104378. doi: 10.1016/j.numecd.2025.104378. Epub 2025 Oct 16.

    PubMed 41145327

  • 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.

    PubMed 27464488

Questions about this trial

What is this clinical trial studying?

A study testing DI, PAI and PADI in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight reduction (time frame: baseline - 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622711, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.

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