Hôpital La Pitié Salpêtrière
Paris, 75013, France
Location status: Recruiting
Location contact
Fatiha Djennaoui, CP manager
CONTACT
Sofia Zemouri, CP manager
CONTACT
NCT Number: NCT04941651
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Paris, 75013, France
Location status: Recruiting
Fatiha Djennaoui, CP manager
CONTACT
Sofia Zemouri, CP manager
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
Time frame: 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.
Time frame: 6 months
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Time frame: 6 months
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Time frame: 12 months
Weight, in Kg, measured in the same conditon at baseline and 12 months.
Time frame: 6 months
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Time frame: 12 months
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Time frame: 12 months
Plasma fasting levels of triglycerides in g/L
Time frame: 12 months
Plasma fasting levels of HDL cholesterol in g/L
Time frame: 12 months
Plasma fasting levels of LDL cholesterol in g/L
Time frame: 12 months
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Time frame: 12 months
Plasma fasting levels of glucose in g/L
Time frame: 12 months
Plasma fasting levels of HbA1c in percentage
Time frame: 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
Time frame: 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
Time frame: 6 months
Plasma fasting levels of triglycerides in g/L
Time frame: 6 months
Plasma fasting levels of HDL cholesterol in g/L
Time frame: 6 months
Plasma fasting levels of LDL cholesterol in g/L
Time frame: 6 months
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Time frame: 6 months
Plasma fasting levels of glucose in g/L
Time frame: 6 months
Plasma fasting levels of HbA1c in percentage
Time frame: 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
Time frame: 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
Time frame: 12 months
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
Time frame: 12 months
Change between 0 and 12 months in terms of perrcentage of consumption of fruits and vegetables on the recommended 400 g/day
Time frame: 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
Time frame: 6 months
Change between 0 and 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day
Time frame: 12 months
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 6 months
Time frame: 6 months
Time frame: 12 months
Time frame: 6 months
Time frame: 12 months
Time frame: 6 months
Time frame: 12 months
Time frame: 12 months
Time frame: 6 months
Time frame: 6 months
Time frame: 12 months
Time frame: 6 months
Time frame: 12 months
Contact information is provided by the study sponsor or research team.
Boris Hansel, MD, PhD
CONTACT
Marylou Para, PHU
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Acronym: TOOLBAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06390345
Apnea, Body Weight
Boise, Idaho, United States
View Trial DetailsNCT06282952
Body Weight, Cesarean Section
Oulu, Finland
View Trial DetailsNCT06147973
Body Weight, Nutrition Disorders
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT05770570
Body Weight, Nutrition Disorders
New York, United States
View Trial Details