Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer
InForma
1 other identifier
interventional
262
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2015
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedJanuary 30, 2020
January 1, 2020
3.7 years
November 6, 2015
January 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body weight reduction
weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer
baseline - 6 month
Secondary Outcomes (11)
Long-term body weight control
baseline - 12 month - 24 month
Pedometer Step Count
baseline - 6 month - 12 month - 24 month
Physical activity level
baseline - 6 month - 12 month - 24 month
Dietary intake
baseline - 6 month - 24 month
Quality of life
baseline - 6 month - 12 month - 24 month
- +6 more secondary outcomes
Study Arms (4)
DI Dietary Intervention
EXPERIMENTALIndividualized dietary counselling to reduce body weight
PAI Physical Activity Intervention
EXPERIMENTALIndividualized physical activity counseling to reduce body weight
PADI Physical Activity+Diet Intervention
EXPERIMENTALIndividualized dietary and physical activity counseling to reduce body weight
LII Less Intensive Intervention
EXPERIMENTALMaterials and guidelines available to general public
Interventions
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.
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.
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.
Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IEO Istituto Europeo di Oncologia
Milan, 20141, Italy
Related Publications (2)
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.
PMID: 41145327DERIVEDGnagnarella 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.
PMID: 27464488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Maisonneuve
European Institue of Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2015
First Posted
December 4, 2015
Study Start
November 1, 2015
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
January 30, 2020
Record last verified: 2020-01