Mobile Tele-rehabilitation Solution for Obese Patients.

Obesity Clinical Trial

Official title:

Impact of a Mobile Tele-rehabilitation Solution on Body Composition of Obese Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03396666
• Other study ID #: UF 9799
• Status: Terminated
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: May 28, 2018

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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, the investigators 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. The investigators 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: May 28, 2018
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion criteria:

• Body Mass Index > 30 kg/m²
• Age 20-65 years

Exclusion criteria:

• Unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
• No internet access at home

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Telemouv
Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of the amount of fat mass	Modification of the amount of fat mass, expressed in kilograms	Month 3