Clinical trial NCT06577545: Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.
Official title: Design, Implementation and Evaluation of a Behavioural Intervention to Treat Obesity in Breast Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Overweight and Obesity
Keywords: behavioural intervention
lifestyle intervention
nutrition and physical activity
breast cancer survivors
overweight and obesity
digital counselling
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 40 kg/m2

Exclusion Criteria:

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

Primary outcomes:
measure: body weight change
timeFrame: From enrollment to the end of treatment at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: University of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Odysseas Androutsos, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.