Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity. (Nutri-Life)

University of Thessaly

Status: Not yet enrolling

Conditions: Breast Cancer Female; Overweight and Obesity

Treatments: Behavioral: Behavioural Lifestyle (BL)

Study type: Interventional

Funder types: Other

Identifiers

NCT06577545

Behavioral Intervention in BCS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI between 25 and 40 kg/m2

Exclusion criteria

• active cancer or any ongoing treatment except hormonal or immune therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Usual Care (UC)

No Intervention group

Description:

Participants in Usual Care (UC) study arm will receive WCRF cancer prevention recommendations.

Behavioural Lifestyle (BL)

Active Comparator group

Description:

24-week behavioural lifestyle intervention program.

Treatment:

Behavioral: Behavioural Lifestyle (BL)