Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.
NCT ID: NCT06577545
Last Updated: 2024-08-29
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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NOT_YET_RECRUITING
NA
92 participants
INTERVENTIONAL
2026-01-31
2026-07-31
Brief Summary
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1. If the participants of the BL group will lose more weight than the UC group.
2. If the participants of the BL group will have more lifestyle benefits than the UC group.
Volunteers will participate in a 24-week behavioural program. This program aims to improve their nutrition and physical activity in order to lose at least 10% of their initial body weight.
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Detailed Description
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The usual care (UC) group will receive WCRF cancer prevention recommendations. The behavioural lifestyle intervention program (BL) group will participate in a 24-week intervention targeting diet and physical activity to lose weight.
The program will be considered successful if participants lose at least 10% of their initial body weight. A secondary goal is to improve their nutrition and physical activity levels. The third and last goal is to improve their overall quality of life and their anxiety levels.
The behavioral program includes in-person online meetings, group online sessions, and digital counseling material. Considering that participants will be residing all around Greece, an internet videoconferencing technology will be required.
A qualitative study incorporating focus groups undertaken prior to this study to establish the methodology resulted in the utilization of synchronous and asynchronous media, as well as a combination of in-person and group sessions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Usual Care (UC)
Participants in Usual Care (UC) study arm will receive WCRF cancer prevention recommendations.
No interventions assigned to this group
Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention program.
Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention
Interventions
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Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
FEMALE
Yes
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Odysseas Androutsos
Professor of Nutrition and Clinical Dietetics, Department of Nutrition and Dietetics
Principal Investigators
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Odysseas Androutsos, Professor
Role: STUDY_CHAIR
University of Thessaly
Locations
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University of Thessaly
Trikala, Thessaly, Greece
Countries
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Central Contacts
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Facility Contacts
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References
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Perperidi M, Saliari D, Christakis C, Huybrechts I, Saloustros E, Theodorakis Y, Androutsos O. Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. Cancer Causes Control. 2023 Aug;34(8):683-703. doi: 10.1007/s10552-023-01707-w. Epub 2023 May 6.
Perperidi M, Saltaouras G, Konstandis A, De Craemer M, Saloustros E, Theodorakis Y, Androutsos O. Barriers and facilitators of healthy lifestyle and perspectives towards the development of weight loss programmes. Focus groups with post-treatment breast cancer survivors in Greece. J Nutr Sci. 2023 Nov 3;12:e111. doi: 10.1017/jns.2023.94. eCollection 2023.
Saltaouras G, Perperidi M, Vantzou D, Vatsina K, Saloustros E, Theodorakis Y, Androutsos O. Determinants of lifestyle and body weight status among breast cancer survivors with overweight/obesity and perspectives towards the development of weight loss interventions: a qualitative study with health professionals from Greece. J Nutr Sci. 2024 Jan 23;13:e4. doi: 10.1017/jns.2023.117. eCollection 2024.
Other Identifiers
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Behavioral Intervention in BCS
Identifier Type: -
Identifier Source: org_study_id
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