Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
NCT ID: NCT04941651
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
346 participants
INTERVENTIONAL
2024-01-02
2026-11-15
Brief Summary
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Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support.
In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor.
A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.
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Detailed Description
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Patients will be assessed at baseline, 6 months and 12 months. In an ancillary study they could be also assessed at 24 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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OBE-COACH program
The OBE-COACH experimental group: access to the complete OBE-COACH program
OBE-COACH program
OBE-COACH works through private exchanges between the user and an automatic generator of recommendations, advice and messages of encouragement. Web focus groups are propoposed by specialist to respond to the questions of the participants and a tele-interview at 6 months with a dietetician to encourage and assist the patient to make the best use of the program.
The program is divided into missions to perform. These missions are grouped into 10 families. The completion of each mission and the correct answers to the quiz offer points and bonuses.
To promote better adherence to the program, missions are not repetitive. They are proposed to surprise the user and constantly renew his desire to connect to the program and achieve goals.
The intensity level of the program is selected by the user at any time.
Connected devices
Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program.
The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate.
The balance (Web coach premium, Terraillon) is a connected scale to collect body weight.
Connected Activity Tracer
The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program.
e-learning program
The control group: access to an e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health) and provision of connected devices (auto-tensiometer and balance).
Connected devices
Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program.
The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate.
The balance (Web coach premium, Terraillon) is a connected scale to collect body weight.
Connected Activity Tracer
The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program.
e-learning program
e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health)
Interventions
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OBE-COACH program
OBE-COACH works through private exchanges between the user and an automatic generator of recommendations, advice and messages of encouragement. Web focus groups are propoposed by specialist to respond to the questions of the participants and a tele-interview at 6 months with a dietetician to encourage and assist the patient to make the best use of the program.
The program is divided into missions to perform. These missions are grouped into 10 families. The completion of each mission and the correct answers to the quiz offer points and bonuses.
To promote better adherence to the program, missions are not repetitive. They are proposed to surprise the user and constantly renew his desire to connect to the program and achieve goals.
The intensity level of the program is selected by the user at any time.
Connected devices
Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program.
The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate.
The balance (Web coach premium, Terraillon) is a connected scale to collect body weight.
Connected Activity Tracer
The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program.
e-learning program
e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health)
Eligibility Criteria
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Inclusion Criteria
* Obesity defined by a body mass index \> 30 kg / m2 or a BMI\> 25 kg / m2 with the presence of at least one major cardiometabolic risk factors among the followings: dyslipidemia, hypertension, diabetes, prediabetes
* Stable weight in the last six months (weight variation \< 4 kg peak-to-peak)
* Access and current use of internet, possession of an email address and a smartphone.
* Understanding and reading French
* Patient not currently following a nutritional monitoring and not having planned to be engaged in a nutritional monitoring during the coming year
Exclusion Criteria
* symptomatic cardiovascular disease : angina, lower extremity arterial occlusive disease, stroke or myocardial infarction dating of less than 6 months.
* Uncontrolled psychiatric illness
* Patients receiving or about to receive during the study period a systemic or local treatment susceptible to interfere with the evaluation of the primary criteria (corticosteroids, antipsychotics, tricyclic antidepressants) except if these treatments have been stable for at least 6 months without a plan to modify the dose during the 12 months of the study
* Adhering to a prescribed diet for weight loss, in the past 3 months
* Person with a severe eating disorder: bulimia, binge eating disorder according to DSM-V criteria - Presence of celiac disease, Crohn's disease or other metabolic disorder or condition affecting nutritional needs such as allergies or food intolerances (except partial lactose intolerance)
* Anticipated difficulties in following the patient
* Lack of social coverage in France
* Lack of written or electronic informed consent
18 Years
75 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marylou Para, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital La Pitié Salpêtrière
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TOOLBAR K160908J
Identifier Type: -
Identifier Source: org_study_id
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