Clinical Trials Directory

Trials / Completed

CompletedNCT04304924

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
220 (actual)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERThe personalized telephone based interventionThe 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.

Timeline

Start date
2020-06-17
Primary completion
2023-06-21
Completion
2025-05-22
First posted
2020-03-12
Last updated
2026-04-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04304924. Inclusion in this directory is not an endorsement.