Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

Summary

The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Conditions

• Hereditary Breast and Ovarian Cancer

Interventions

BEHAVIORAL

Structured exercise training plus mediterranean diet

Structured exercise training plus mediterranean diet

Sponsors & Collaborators

• University of Hohenheim

  collaborator OTHER

• University Hospital Schleswig-Holstein

  collaborator OTHER

• University of Leipzig

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• Technical University of Munich

  lead OTHER

Principal Investigators

• Marion Kiechle, Prof. Dr. · Technical University of Munich

• Martin Halle, Prof. Dr. · Technical University of Munich

• Stephan C Bischoff, Prof. Dr. · Universitaet Hohenheim, Stuttgart

• Michael Siniatchkin, Prof. Dr. · University Hospital Schleswig-Holstein

• Markus Loeffler, Prof. Dr. · University of Leipzig

• Christoph Engel, PD Dr. · University of Leipzig

• Rita K Schmutzler, Prof. Dr. · University of Cologne

• Alfons Meindl, Prof. Dr. · Technical University of Munich

• Anne S Quante, Dr. · Technical University of Munich

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Germany

Study Locations