Wirksamkeit der Telenutrition zur Behandlung von übergewichtigen Patienten mit Adipositas und/oder hohem kardiometabolischem Risiko (TOOLBAR)
Wirksamkeit der Telenutrition (OBE-COACH) zur Behandlung von übergewichtigen Patienten mit Adipositas und/oder hohem kardiometabolischem Risiko
The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels.
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The management of patients in the TOOLBAR study will be in accordance with French recommendations: a patient who is overweight should benefit from a dietary, physical activity, psychological assistance and medical monitoring advices which can be provided by a general practitioner. In the control group, subjects have access to an e-learning program, including free access via the web to a nutritional information portal and to automated tools providing information and advice for adopting a balanced, low-carb diet and to practice physical activity in line with the guidelines of the national health nutrition plan (PNNS). However, this group will not have access to the OBE-COACH program. The usual follow-up with the attending doctor will be continued.
Patients will be assessed at baseline, 6 months and 12 months. In an ancillary study they could be also assessed at 24 months.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Paris, Frankreich, 75013
- Hôpital La Pitié Salpêtrière
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men or women 18 to 75 years
- 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:
- Excessive alcohol consumption > 30 g / day -Pregnant or breastfeeding woman
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: OBE-COACH program
The OBE-COACH experimental group: access to the complete 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 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. 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. |
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Aktiver Komparator: 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 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. 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 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) |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Weight reduction of at least 5% between 0 and 12 months.
Zeitfenster: 12 months
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Weight reduction of at least 5% between 0 and 12 months. The weight, in Kg, will be measured in a state of fastness ≥ 8h, in participants wearing light clothing without shoes on the same scales calibrated at inclusion and 12 months of follow-up. |
12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Veränderung der Proteinzufuhr zwischen 0 und 12 Monaten in g/Tag, bewertet mit dem validierten NAQA-Fragebogen
Zeitfenster: 12 Monate
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12 Monate
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Veränderung der Saccharosezufuhr zwischen 0 und 12 Monaten in g/Tag, ausgewertet mit dem validierten NAQA-Fragebogen
Zeitfenster: 12 Monate
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12 Monate
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Veränderung der Lipidaufnahme zwischen 0 und 12 Monaten in g/Tag, ausgewertet mit dem validierten NAQA-Fragebogen
Zeitfenster: 12 Monate
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12 Monate
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Veränderung der Kalziumaufnahme zwischen 0 und 12 Monaten in mg/Tag, ausgewertet mit dem validierten NAQA-Fragebogen
Zeitfenster: 12 Monate
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12 Monate
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Änderung des Konsums zuckerhaltiger Getränke zwischen 0 und 12 Monaten in Anzahl der Gläser/Tag
Zeitfenster: 12 Monate
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12 Monate
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Veränderung des Alkoholkonsums zwischen 0 und 12 Monaten in Anzahl der Gläser/Tag
Zeitfenster: 12 Monate
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12 Monate
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Änderung des Konsums zuckerhaltiger Getränke zwischen 0 und 6 Monaten in Anzahl der Gläser/Tag
Zeitfenster: 6 Monate
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6 Monate
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Änderung des Alkoholkonsums zwischen 0 und 6 Monaten in Anzahl der Gläser/Tag
Zeitfenster: 6 Monate
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6 Monate
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Veränderung zwischen 0 und 12 Monaten Tabakkonsum in Anzahl Zigaretten/Tag
Zeitfenster: 12 Monate
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12 Monate
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Veränderung zwischen 0 und 6 Monaten Tabakkonsum in Anzahl Zigaretten/Tag
Zeitfenster: 6 Monate
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6 Monate
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Veränderung zwischen 0 und 12 Monaten Einhaltung der WHO-Empfehlungen für körperliche Aktivität, gemessen in Metabolic Equivalent of Task, MET, bewertet mit dem GPAQ-Fragebogen.
Zeitfenster: 12 Monate
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12 Monate
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Veränderung zwischen 0 und 6 Monaten Einhaltung der WHO-Empfehlungen für körperliche Aktivität, gemessen in Metabolic Equivalent of Task, MET, bewertet mit dem GPAQ-Fragebogen.
Zeitfenster: 6 Monate
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6 Monate
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Einhaltung des OBE-COACH-Programms nach 12 Monaten, bewertet anhand des durchschnittlichen Prozentsatzes der Fragen (von IRIADE gesendet) mit Antworten des Probanden pro Woche im Vormonat.
Zeitfenster: 12 Monate
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12 Monate
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Einhaltung des OBE-COACH-Programms nach 12 Monaten, bewertet anhand der Anzahl der Teilnahmen an Web-Fokusgruppen in den letzten 6 Monaten.
Zeitfenster: 12 Monate
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12 Monate
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Einhaltung des OBE-COACH-Programms nach 6 Monaten, bewertet anhand des durchschnittlichen Prozentsatzes der Fragen (von IRIADE gesendet) mit Antworten des Probanden pro Woche im Vormonat.
Zeitfenster: 6 Monate
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6 Monate
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Einhaltung des OBE-COACH-Programms nach 6 Monaten, bewertet anhand der Anzahl der Teilnahmen an Web-Fokusgruppen in den letzten 6 Monaten.
Zeitfenster: 6 Monate
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6 Monate
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Veränderung zwischen 0 und 12 Monaten der Nahrungsimpulsivität, bewertet durch den TFEQ21-Fragebogen
Zeitfenster: 12 Monate
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12 Monate
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Veränderung zwischen 0 und 6 Monaten der Nahrungsimpulsivität, bewertet durch den TFEQ21-Fragebogen
Zeitfenster: 6 Monate
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6 Monate
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Entwicklung von Angstsymptomen zwischen 0 und 12 Monaten, gemessen mit dem HAD-Fragebogen (Punktzahl 0 bis 21)
Zeitfenster: 12 Monate
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12 Monate
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Weight reduction of at least 5% between 0 and 6 months.
Zeitfenster: 6 months
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Weight, in Kg, measured in the same conditon at baseline and 6 months. |
6 months
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Weight change between 0 and 6 months
Zeitfenster: 6 months
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Weight, in Kg, measured in the same conditon at baseline and 6 months. |
6 months
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Weight change between 0 and 12 months
Zeitfenster: 12 months
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Weight, in Kg, measured in the same conditon at baseline and 12 months. |
12 months
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Waist change between 0 and 6 months
Zeitfenster: 6 months
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Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest |
6 months
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Waist change between 0 and 12 months
Zeitfenster: 12 months
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Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest |
12 months
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Triglycerids change between 0 and 12 months
Zeitfenster: 12 months
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Plasma fasting levels of triglycerides in g/L |
12 months
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HDL cholesterol change between 0 and 12 months
Zeitfenster: 12 months
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Plasma fasting levels of HDL cholesterol in g/L |
12 months
|
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LDL cholesterol change between 0 and 12 months
Zeitfenster: 12 months
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Plasma fasting levels of LDL cholesterol in g/L |
12 months
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non-HDL cholesterol change between 0 and 12 months
Zeitfenster: 12 months
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Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C) |
12 months
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Blood glucose change between 0 and 12 months
Zeitfenster: 12 months
|
Plasma fasting levels of glucose in g/L |
12 months
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HbA1c change between 0 and 12 months
Zeitfenster: 12 months
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Plasma fasting levels of HbA1c in percentage |
12 months
|
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Systolic blood pressure change between 0 and 12 months
Zeitfenster: 12 months
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Systolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
12 months
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Diastolic blood pressure change between 0 and 12 months
Zeitfenster: 12 months
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Diastolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
12 months
|
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Triglycerids change between 0 and 6 months
Zeitfenster: 6 months
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Plasma fasting levels of triglycerides in g/L |
6 months
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HDL cholesterol change between 0 and 6 months
Zeitfenster: 6 months
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Plasma fasting levels of HDL cholesterol in g/L |
6 months
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LDL cholesterol change between 0 and 6 months
Zeitfenster: 6 months
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Plasma fasting levels of LDL cholesterol in g/L |
6 months
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non-HDL cholesterol change between 0 and 6 months
Zeitfenster: 6 months
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Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C) |
6 months
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Blood glucose change between 0 and 6 months
Zeitfenster: 6 months
|
Plasma fasting levels of glucose in g/L |
6 months
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|
HbA1c change between 0 and 6 months
Zeitfenster: 6 months
|
Plasma fasting levels of HbA1c in percentage |
6 months
|
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Systolic blood pressure change between 0 and 6 months
Zeitfenster: 6 months
|
Systolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
6 months
|
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Diastolic blood pressure change between 0 and 6 months
Zeitfenster: 6 months
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Diastolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
6 months
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Change in adherence to the Mediterranean diet : Score PREDIMED
Zeitfenster: 12 months
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Change between 0 and 12 months of adherence to mediterranean diet,evaluated by the dietetic score PREDIMED (validated checklist of 14 items). Higher scores indicate greater adherence to the diet assigned |
12 months
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Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Zeitfenster: 12 months
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Change between 0 and 12 months in terms of perrcentage of consumption of fruits and vegetables on the recommended 400 g/day |
12 months
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Change in adherence to the Mediterranean diet : Score PREDIMED
Zeitfenster: 6 months
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Change between 0 and 6 months of adherence to mediterranean diet,evaluated by the dietetic score PREDIMED (validated checklist of 14 items). Higher scores indicate greater adherence to the diet assigned |
6 months
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Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Zeitfenster: 6 months
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Change between 0 and 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day |
6 months
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Change between 0 and 12 months of Energy intake
Zeitfenster: 12 months
|
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire |
12 months
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Change between 0 and 12 months of cholesterol intake
Zeitfenster: 12 months
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Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire |
12 months
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Marylou Para, MD, PhD, Assistance Publique - Hôpitaux de Paris
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- K160908J
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Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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