ObesityNCT03396666
Mobile Tele-rehabilitation Solution for Obese Patients.
A study testing Telemouv in people with Obesity, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Telemouv
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2018to 28 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index > 30 kg/m²
- Age 20-65 years
Who cannot join
- Unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
- No internet access at home
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Montpellier
Montpellier, Montpellier, 34295
About this study
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
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- Telemouv
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemouvOther
Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months
| Study group | Role | What they receive |
|---|---|---|
| Telemouv | Experimental | Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months Receives: Other: Telemouv |
| No intervention | No intervention | Regular follow-up with advice on physical activity and nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of the amount of fat mass
Modification of the amount of fat mass, expressed in kilograms
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start17 Jan 2018
- Primary completion28 May 2018
- Study completion28 May 2018
Why it stopped: Inclusion of the last Patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396666
- Sponsor's protocol ID
- RECHMPL17_0031
- Other IDs
- 2017-A01190-53
- Status last verified
- Dec 2021
- First submitted
- 4 Jan 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bughin F, Bui G, Ayoub B, Blervaque L, Saey D, Avignon A, Brun JF, Molinari N, Pomies P, Mercier J, Gouzi F, Hayot M. Impact of a Mobile Telerehabilitation Solution on Metabolic Health Outcomes and Rehabilitation Adherence in Patients With Obesity: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 6;9(12):e28242. doi: 10.2196/28242.
PubMed 34874887
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mobile Tele-rehabilitation Solution on Body Composition of Obese Patients.
- ClinicalTrials.gov ID
- NCT03396666
- Acronym / sponsor ID
- RECHMPL17_0031
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion of the last Patient
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemouv | Experimental | Other: TelemouvTelemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months |
| No intervention | No intervention | –Regular follow-up with advice on physical activity and nutrition |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index > 30 kg/m²
- Age 20-65 years
Key exclusion criteria (2 listed)
- Unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
- No internet access at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemouvTelemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months | Other | Telemouv |
Primary outcome
Modification of the amount of fat mass
Time frame: Month 3
Modification of the amount of fat mass, expressed in kilograms
Results and safety
The study was stopped early (reason given: Inclusion of the last Patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 34874887Bughin F, Bui G, Ayoub B, Blervaque L, Saey D, Avignon A, Brun JF, Molinari N, Pomies P, Mercier J, Gouzi F, Hayot M. Impact of a Mobile Telerehabilitation Solution on Metabolic Health Outcomes and Rehabilitation Adherence in Patients With Obesity: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 6;9(12):e28242. doi: 10.2196/28242.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemouv in people with Obesity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion of the last Patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of the amount of fat mass (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.