Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 346
- 试验地点
- 2
- 主要终点
- Weight reduction of at least 5% between 0 and 12 months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Weight reduction of at least 5% between 0 and 12 months.
时间窗: 12 months
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.
次要结局
- Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire(12 months)
- LDL cholesterol change between 0 and 6 months(6 months)
- Weight reduction of at least 5% between 0 and 6 months.(6 months)
- Triglycerids change between 0 and 12 months(12 months)
- Systolic blood pressure change between 0 and 6 months(6 months)
- non-HDL cholesterol change between 0 and 12 months(12 months)
- Weight change between 0 and 12 months(12 months)
- Waist change between 0 and 6 months(6 months)
- Weight change between 0 and 6 months(6 months)
- HDL cholesterol change between 0 and 12 months(12 months)
- LDL cholesterol change between 0 and 12 months(12 months)
- HbA1c change between 0 and 12 months(12 months)
- Blood glucose change between 0 and 6 months(6 months)
- Diastolic blood pressure change between 0 and 6 months(6 months)
- Waist change between 0 and 12 months(12 months)
- Blood glucose change between 0 and 12 months(12 months)
- Systolic blood pressure change between 0 and 12 months(12 months)
- Triglycerids change between 0 and 6 months(6 months)
- non-HDL cholesterol change between 0 and 6 months(6 months)
- HbA1c change between 0 and 6 months(6 months)
- Diastolic blood pressure change between 0 and 12 months(12 months)
- HDL cholesterol change between 0 and 6 months(6 months)
- Change between 0 and 6 months of sugary drinks consumption in number of glasses/day(6 months)
- Change between 0 and 6 months of Adherence to the WHO recommendations for physical activity, measured in Metabolic Equivalent of Task, MET, evaluated with the GPAQ questionnaire.(6 months)
- Adherence to OBE-COACH program at 12 months, evaluated by the number of participation in web focus groups over the last 6 months.(12 months)
- Adherence to OBE-COACH program at 6 months, evaluated by the number of participation in web focus groups over the last 6 months.(6 months)
- Change between 0 and 12 months of Food impulsivity evaluated by the TFEQ21 questionnaire(12 months)
- Change between 0 and 6 months of Food impulsivity evaluated by the TFEQ21 questionnaire(6 months)
- Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire(12 months)
- Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire(12 months)
- Change between 0 and 6 months of tobacco consumption in number of cigarettes/day(6 months)
- Change in adherence to the Mediterranean diet : Score PREDIMED(6 months)
- Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire(12 months)
- Change between 0 and 12 months of sugary drinks consumption in number of glasses/day(12 months)
- Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day(12 months)
- Change between 0 and 12 months of Adherence to the WHO recommendations for physical activity, measured in Metabolic Equivalent of Task, MET, evaluated with the GPAQ questionnaire.(12 months)
- Change in adherence to the Mediterranean diet : fruits and vegetables consumption(6 months)
- Change between 0 and 12 months of Energy intake(12 months)
- Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day(6 months)
- Change between 0 and 12 months of tobacco consumption in number of cigarettes/day(12 months)
- Adherence to OBE-COACH program at 12 months, evaluated by the average percentage of questions (sent by IRIADE) with replies from the subject per week during the previous month.(12 months)
- Evolution between 0 and 12 months of Symptoms of anxiety, measured with the HAD questionnaire (score 0 to 21)(12 months)
- Adherence to OBE-COACH program at 6 months, evaluated by the average percentage of questions (sent by IRIADE) with replies from the subject per week during the previous month.(6 months)
- Change between 0 and 12 months of cholesterol intake(12 months)