Breast Cancer Female, Overweight and Obesity
Conditions
Keywords
behavioural intervention, lifestyle intervention, nutrition and physical activity, breast cancer survivors, overweight and obesity, digital counselling
Brief summary
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: 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.
Detailed description
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.
Interventions
BEHAVIORALBehavioural Lifestyle (BL)
24-week behavioural lifestyle intervention
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 25 and 40 kg/m2
Exclusion criteria
* active cancer or any ongoing treatment except hormonal or immune therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight change | From enrollment to the end of treatment at 24 weeks | % of the initial body weight change |
Countries
Greece
Contacts
Primary ContactOdysseas Androutsos, Professor
Backup ContactMaria Perperidi, PhDc
Outcome results
None listed