Eficacia de la telenutrición para el tratamiento de pacientes con sobrepeso, obesidad y/o alto riesgo cardiometabólico (TOOLBAR)
Eficacia de la Telenutrición (OBE-COACH) para el Tratamiento de Pacientes con Sobrepeso con Obesidad y/o Alto Riesgo Cardiometabólico
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Paris, Francia, 75013
- Hôpital La Pitié Salpêtrière
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Comparador activo: 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) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Weight reduction of at least 5% between 0 and 12 months.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cambio entre 0 y 12 meses del consumo de proteínas, en g/día, evaluado con el cuestionario NAQA validado
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 12 meses de ingesta de sacarosa en g/día, evaluado con el cuestionario NAQA validado
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 12 meses de ingesta de lípidos en g/día, evaluado con el cuestionario NAQA validado
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 12 meses de la ingesta de calcio en mg/día, evaluado con el cuestionario NAQA validado
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 12 meses de consumo de bebidas azucaradas en número de vasos/día
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 12 meses de consumo de bebidas alcohólicas en número de vasos/día
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 6 meses de consumo de bebidas azucaradas en número de vasos/día
Periodo de tiempo: 6 meses
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6 meses
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Cambio entre 0 y 6 meses de consumo de bebidas alcohólicas en número de vasos/día
Periodo de tiempo: 6 meses
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6 meses
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Cambio entre 0 y 12 meses de consumo de tabaco en número de cigarrillos/día
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 6 meses de consumo de tabaco en número de cigarrillos/día
Periodo de tiempo: 6 meses
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6 meses
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Cambio entre 0 y 12 meses de Adhesión a las recomendaciones de actividad física de la OMS, medida en Metabolic Equivalent of Task, MET, evaluada con el cuestionario GPAQ.
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 6 meses de Adhesión a las recomendaciones de actividad física de la OMS, medida en Metabolic Equivalent of Task, MET, evaluada con el cuestionario GPAQ.
Periodo de tiempo: 6 meses
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6 meses
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Adherencia al programa OBE-COACH a los 12 meses, evaluada por el porcentaje promedio de preguntas (enviadas por IRIADE) con respuesta del sujeto por semana durante el mes anterior.
Periodo de tiempo: 12 meses
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12 meses
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Adherencia al programa OBE-COACH a los 12 meses, evaluada por el número de participación en grupos focales web en los últimos 6 meses.
Periodo de tiempo: 12 meses
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12 meses
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Adhesión al programa OBE-COACH a los 6 meses, evaluada por el porcentaje medio de preguntas (enviadas por IRIADE) con respuesta del sujeto por semana durante el mes anterior.
Periodo de tiempo: 6 meses
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6 meses
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Adherencia al programa OBE-COACH a los 6 meses, evaluada por el número de participación en grupos focales web en los últimos 6 meses.
Periodo de tiempo: 6 meses
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6 meses
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Cambio entre 0 y 12 meses de Impulsividad alimentaria evaluada por el cuestionario TFEQ21
Periodo de tiempo: 12 meses
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12 meses
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Cambio entre 0 y 6 meses de Impulsividad alimentaria evaluada por el cuestionario TFEQ21
Periodo de tiempo: 6 meses
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6 meses
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Evolución entre 0 y 12 meses de Síntomas de ansiedad, medida con el cuestionario HAD (puntuación 0 a 21)
Periodo de tiempo: 12 meses
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12 meses
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Weight reduction of at least 5% between 0 and 6 months.
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 12 months
|
Plasma fasting levels of glucose in g/L |
12 months
|
|
HbA1c change between 0 and 12 months
Periodo de tiempo: 12 months
|
Plasma fasting levels of HbA1c in percentage |
12 months
|
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Systolic blood pressure change between 0 and 12 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
Plasma fasting levels of HDL cholesterol in g/L |
6 months
|
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LDL cholesterol change between 0 and 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
Plasma fasting levels of glucose in g/L |
6 months
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HbA1c change between 0 and 6 months
Periodo de tiempo: 6 months
|
Plasma fasting levels of HbA1c in percentage |
6 months
|
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Systolic blood pressure change between 0 and 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
|
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
Periodo de tiempo: 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
Periodo de tiempo: 12 months
|
Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire |
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marylou Para, MD, PhD, Assistance Publique - Hôpitaux de Paris
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K160908J
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Criterios de acceso compartido de IPD
Researchers who provide a methodologically sound proposal
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .