Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

Официальное название

Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 cor
• Устройство 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.
• Устройство 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.
• Поведенческое 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)

Первичные конечные точки

• Weight reduction of at least 5% between 0 and 12 months. [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Weight reduction of at least 5% between 0 and 6 months. [Срок оценки: 6 months]
• Weight change between 0 and 6 months [Срок оценки: 6 months]
• Weight change between 0 and 12 months [Срок оценки: 12 months]
• Waist change between 0 and 6 months [Срок оценки: 6 months]
• Waist change between 0 and 12 months [Срок оценки: 12 months]
• Triglycerids change between 0 and 12 months [Срок оценки: 12 months]
• HDL cholesterol change between 0 and 12 months [Срок оценки: 12 months]
• LDL cholesterol change between 0 and 12 months [Срок оценки: 12 months]
• non-HDL cholesterol change between 0 and 12 months [Срок оценки: 12 months]
• Blood glucose change between 0 and 12 months [Срок оценки: 12 months]
• HbA1c change between 0 and 12 months [Срок оценки: 12 months]
• Systolic blood pressure change between 0 and 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Hôpital La Pitié Salpêtrière — Paris

Идентификаторы

NCT: NCT04941651 · TOOLBAR K160908J

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗