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

August 27, 2024 updated by: Odysseas Androutsos, University of Thessaly

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Odysseas Androutsos, Professor
  • Phone Number: +30 24310 47108
  • Email: oandroutsos@uth.gr

Study Contact Backup

Study Locations

  • Greece
    • Thessaly
      • Tríkala, Thessaly, Greece, 42132
        • University of Thessaly
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 25 and 40 kg/m2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care (UC)
Participants in Usual Care (UC) study arm will receive WCRF cancer prevention recommendations.
Active Comparator: Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention program.
Behavioral: Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight change
Time Frame: From enrollment to the end of treatment at 24 weeks
% of the initial body weight change
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Study Chair: Odysseas Androutsos, Professor, University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Behavioral Intervention in BCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

Researchers under request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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