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

NCT06577545 | Not Yet Recruiting

• 1 other identifier: Behavioral Intervention in BCS
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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. 1.If the participants of the BL group will lose more weight than the UC group.
2. 2.If the participants of the BL group will have more lifestyle benefits than the UC group.

Conditions

Breast Cancer Female; Overweight and Obesity

Keywords

behavioural intervention; lifestyle intervention; nutrition and physical activity; breast cancer survivors; overweight and obesity; digital counselling

Outcome Measures

Primary Outcomes (1)

• body weight change

  % of the initial body weight change

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

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

Behavioural Lifestyle (BL)

ACTIVE COMPARATOR

24-week behavioural lifestyle intervention program.

Behavioral: Behavioural Lifestyle (BL)

Interventions

Behavioural Lifestyle (BL) BEHAVIORAL

24-week behavioural lifestyle intervention

Behavioural Lifestyle (BL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study includes only biological female participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 25 and 40 kg/m2

You may not qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University of Thessaly

Trikala, Thessaly, 42132, Greece

Location

Related Publications (3)

• 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.

  PMID: 37149509 BACKGROUND

• 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.

  PMID: 37964978 BACKGROUND

• 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.

  PMID: 38282654 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Odysseas Androutsos, Professor

  University of Thessaly

  STUDY CHAIR

Central Study Contacts

Odysseas Androutsos, Professor

CONTACT

+30 24310 47108; oandroutsos@uth.gr

Maria Perperidi, PhDc

CONTACT

+306947272639; mperperidi@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition and Clinical Dietetics, Department of Nutrition and Dietetics

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Researchers under request

Locations

GR (1)