Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
- Conditions
- Overweight and Obesity
- Interventions
- Device: Connected devicesBehavioral: OBE-COACH programDevice: Connected Activity TracerBehavioral: e-learning program
- Registration Number
- NCT04941651
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 346
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description e-learning 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). e-learning program Connected devices 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). e-learning program Connected Activity Tracer 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). OBE-COACH program OBE-COACH program The OBE-COACH experimental group: access to the complete OBE-COACH program OBE-COACH program Connected devices The OBE-COACH experimental group: access to the complete OBE-COACH program OBE-COACH program Connected Activity Tracer The OBE-COACH experimental group: access to the complete OBE-COACH program
- Primary Outcome Measures
Name Time Method Weight reduction of at least 5% between 0 and 12 months. 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.
- Secondary Outcome Measures
Name Time Method 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 Plasma fasting levels of LDL cholesterol in g/L
Weight reduction of at least 5% between 0 and 6 months. 6 months Weight, in Kg, measured in the same conditon at baseline and 6 months.
Triglycerids change between 0 and 12 months 12 months Plasma fasting levels of triglycerides in g/L
Systolic blood pressure change between 0 and 6 months 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
Weight change between 0 and 12 months 12 months Weight, in Kg, measured in the same conditon at baseline and 12 months.
Waist change between 0 and 6 months 6 months Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
non-HDL cholesterol change between 0 and 12 months 12 months Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Weight change between 0 and 6 months 6 months Weight, in Kg, measured in the same conditon at baseline and 6 months.
HDL cholesterol change between 0 and 12 months 12 months Plasma fasting levels of HDL cholesterol in g/L
LDL cholesterol change between 0 and 12 months 12 months Plasma fasting levels of LDL cholesterol in g/L
HbA1c change between 0 and 12 months 12 months Plasma fasting levels of HbA1c in percentage
Blood glucose change between 0 and 6 months 6 months Plasma fasting levels of glucose in g/L
Diastolic blood pressure change between 0 and 6 months 6 months 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
Waist change between 0 and 12 months 12 months Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Blood glucose change between 0 and 12 months 12 months Plasma fasting levels of glucose in g/L
Systolic blood pressure change between 0 and 12 months 12 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
Triglycerids change between 0 and 6 months 6 months Plasma fasting levels of triglycerides in g/L
non-HDL cholesterol change between 0 and 6 months 6 months Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
HbA1c change between 0 and 6 months 6 months Plasma fasting levels of HbA1c in percentage
Diastolic blood pressure change between 0 and 12 months 12 months 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
HDL cholesterol change between 0 and 6 months 6 months Plasma fasting levels of HDL cholesterol in g/L
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 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
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 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day
Change between 0 and 12 months of Energy intake 12 months Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire
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 Change between 0 and 12 months of cholesterol intake 12 months Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire
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
Trial Locations
- Locations (1)
Hôpital La Pitié Salpêtrière
🇫🇷Paris, France