Obesity Clinical Trial - Mobile Tele-rehabilitation Solution for Obese

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Obesity

Clinical Trial Details

NCT number	NCT03396666
Study type	Interventional
Source	University Hospital, Montpellier
Contact	François BUGHIN
Phone	+33467338284
Email	f-bughin@chu-montpellier.fr
Status	Recruiting
Phase	N/A
Start date	January 17, 2018
Completion date	July 30, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mobile Tele-rehabilitation Solution for Obese Patients.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms