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NCT Number: NCT06577545

Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 25 and 40 kg/m2

Exclusion criteria

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

Treatment and study plan

Behavioural Lifestyle (BL)

Behavioral

24-week behavioural lifestyle intervention

Primary outcomes

  1. body weight change

    Time frame: From enrollment to the end of treatment at 24 weeks

    % of the initial body weight change

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Perperidi, PhDc

CONTACT

[email protected]

+306947272639

Odysseas Androutsos, Professor

CONTACT

[email protected]

+30 24310 47108

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

Design, Implementation and Evaluation of a Behavioural Intervention to Treat Obesity in Breast Cancer Survivors.

Acronym: Nutri-Life

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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