An interventional study of Behavioural Lifestyle (BL) in Breast Cancer Female and Overweight and Obesity, sponsored by University of Thessaly. Status unknown at 1 site in Greece. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by University of Thessaly · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare a behavioural lifestyle intervention program (BL) to usual care (UC) in breast cancer survivors. The main questions it aims to answer are:
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.
Eligible participants should be female breast cancer survivors between the ages of 18 and 65, with a BMI between 25 and 40 kg/m2, and no active cancer therapy or ongoing treatment, except for hormonal or immune therapy.
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's planned enrollment of 92 is above the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →University of Thessaly is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Participants in Usual Care (UC) study arm will receive WCRF cancer prevention recommendations.
24-week behavioural lifestyle intervention program.
Behavioral: Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention
body weight change
% of the initial body weight change
Time frame: From enrollment to the end of treatment at 24 weeks
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 3 years after the publication of results
Access criteria: Researchers under request
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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