Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer
NCT ID: NCT02622711
Last Updated: 2020-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
262 participants
INTERVENTIONAL
2015-11-30
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DI Dietary Intervention
Individualized dietary counselling to reduce body weight
DI
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.
PAI Physical Activity Intervention
Individualized physical activity counseling to reduce body weight
PAI
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.
PADI Physical Activity+Diet Intervention
Individualized dietary and physical activity counseling to reduce body weight
PADI
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.
LII Less Intensive Intervention
Materials and guidelines available to general public
LII
Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.
Interventions
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DI
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.
PAI
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.
PADI
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.
LII
Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Associazione Italiana per la Ricerca sul Cancro
OTHER
European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Patrick Maisonneuve
Role: PRINCIPAL_INVESTIGATOR
European Institue of Oncology
Locations
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IEO Istituto Europeo di Oncologia
Milan, , Italy
Countries
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References
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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. 2025 Oct 16:104378. doi: 10.1016/j.numecd.2025.104378. Online ahead of print.
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.
Other Identifiers
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IEO 0244
Identifier Type: -
Identifier Source: org_study_id
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