Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577545
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of OverweightObesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Design Implementation and Evaluation of a Behavioural Intervention to Treat Obesity in Breast Cancer Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Nutri-Life
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
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 kgm2 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None