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Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer

NCT04304924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-04-01

No results posted yet for this study

Summary

The primary objective of MEDEA is to compare the effect of a personalised telephone-based health education weight loss program based on motivational coaching, exercise and diet versus a standard health educational program control on fatigue of overweight or obese BC patients (as measured by the EORTC QLQ C30 (Aaronson et al. 1993; Sprangers et al. 1996))

Conditions

  • Overweight or Obese Breast Cancer Patients

Interventions

OTHER

The personalized telephone based intervention

The personalized telephone based intervention: 1. Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989); 2. Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2023-06-21
Completion
2025-05-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304924 on ClinicalTrials.gov