Clinical trial · Interventional
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial
NCT02622711CI-TRIAL-00043097InFormacompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DI | Behavioral | — | UNRESOLVED |
| LII | Behavioral | — | UNRESOLVED |
| PADI | Behavioral | — | UNRESOLVED |
| PAI | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- DI Dietary Intervention
- description
- Individualized dietary counselling to reduce body weight
- interventionNames
- Behavioral: DI
- type
- EXPERIMENTAL
- label
- PAI Physical Activity Intervention
- description
- Individualized physical activity counseling to reduce body weight
- interventionNames
- Behavioral: PAI
- type
- EXPERIMENTAL
- label
- PADI Physical Activity+Diet Intervention
- description
- Individualized dietary and physical activity counseling to reduce body weight
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDGnagnarella 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 41145327
- DERIVEDGnagnarella 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 27464488