Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-22 @ 1:08 PM
Study NCT ID:
NCT03396666
Status:
TERMINATED
Last Update Posted:
2025-09-30
First Post:
2018-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Tele-rehabilitation Solution for Obese Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Inclusion of the last Patient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification of the amount of fat mass', 'timeFrame': 'Month 3', 'description': 'Modification of the amount of fat mass, expressed in kilograms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '34874887', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nthe Ivestigators hypothezise that the use of a mobile telerehabilitation solution will encourage the patient to adopt behavioral modifications allowing a reduction of fat mass', 'detailedDescription': '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.\n\nClinical trials have established the efficacy of lifestyle and behavioral interventions in obesity.\n\nThe 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.\n\nThe 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\n\nPatients with BMI \\> 30 kg/m² will be randomized for the intervention.\n\nThe 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\n\nAt 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Body Mass Index \\> 30 kg/m²\n* Age 20-65 years\n\nExclusion criteria:\n\n* Unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)\n* No internet access at home'}, 'identificationModule': {'nctId': 'NCT03396666', 'briefTitle': 'Mobile Tele-rehabilitation Solution for Obese Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Impact of a Mobile Tele-rehabilitation Solution on Body Composition of Obese Patients.', 'orgStudyIdInfo': {'id': 'RECHMPL17_0031'}, 'secondaryIdInfos': [{'id': '2017-A01190-53', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemouv', 'description': 'Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months', 'interventionNames': ['Other: Telemouv']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Regular follow-up with advice on physical activity and nutrition'}], 'interventions': [{'name': 'Telemouv', 'type': 'OTHER', 'description': 'Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months', 'armGroupLabels': ['Telemouv']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'state': 'Montpellier', 'country': 'France', 'facility': 'University Hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}