Obesity Clinical Trial
Official title:
Impact of a Mobile Tele-rehabilitation Solution on Body Composition of Obese Patients.
Published data indicate that rehabilitation in obese patients can result in a loss of body
fat and weight that is correlated to improved physical and psychological condition and
reduced morbidity and mortality.
the Ivestigators hypothezise that the use of a mobile telerehabilitation solution will
encourage the patient to adopt behavioral modifications allowing a reduction of fat mass
Obesity is one of the most important public health care problems worldwide and is associated
with increased morbidity and mortality and high healthcare costs. Not all obese patients have
the same metabolic risk. It is pejorated in case of increase in the fat mass (FM) and
especially when it predominates at the visceral abdominal level.
Clinical trials have established the efficacy of lifestyle and behavioral interventions in
obesity.
The recent development of telerehabilitation is a promising approach that has only been the
subject of pilot studies Therefore, we aim to test the effects of 3 months of
telerehabilitation solution on fat mass evaluated by impedance analysis.
The telerehabilitation program Telemouv includes physical activity sessions with low
intensity endurance training targeted at the level of maximal oxidation, nutritional
monitoring, therapeutic education tools and motivational support
Patients with BMI > 30 kg/m² will be randomized for the intervention.
We also will analyse the effects of the solution on different anthropometric,
metabolic,cardiovascular and psychological parameters, and on rest and exercise metabolism.
Moreover, we will assess behavioural changes in physical activity and nutrition
At the end of the study, patients in the control group will be able to benefit from the
telemouv solution in an ancillary study with a follow-up of three months.
For a alpha threshold of 5% and a study power of 90%, the study should include 22 patients in
each group. Taking in account a possible 10% of dropout the study will need to include 25
patients by randomized arm to demonstrate an effect.
