Overweight and ObesityTOOLBARNCT04941651
Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
A study testing OBE-COACH program, Connected devices and Connected Activity Tracer in people with Overweight and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- OBE-COACH program, Connected devices and Connected Activity Tracer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2024to 22 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Anticipated difficulties in following the patient
- Lack of social coverage in France
- Lack of written or electronic informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
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.
Read more
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- OBE-COACH program, Connected devices, Connected Activity Tracer, e-learning program
- Keywords
- Overweight patients, Obesity, Cardiometabolic risk, telenutrition, online nutritional coaching service
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBE-COACH programBehavioural
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 devicesDevice
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.
Connected Activity TracerDevice
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 programBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| OBE-COACH program | Experimental | The OBE-COACH experimental group: access to the complete OBE-COACH program Receives: Behavioral: OBE-COACH program; Device: Connected devices; Device: Connected Activity Tracer |
| e-learning program | Active comparator | 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). Receives: Device: Connected devices; Device: Connected Activity Tracer; Behavioral: e-learning program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction of at least 5% between 0 and 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.
Measured: 12 months
Secondary outcomes (46)
Weight reduction of at least 5% between 0 and 6 months.
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Measured: 6 months
Weight change between 0 and 6 months
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Measured: 6 months
Weight change between 0 and 12 months
Weight, in Kg, measured in the same conditon at baseline and 12 months.
Measured: 12 months
Waist change between 0 and 6 months
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Measured: 6 months
Waist change between 0 and 12 months
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Measured: 12 months
Triglycerids change between 0 and 12 months
Plasma fasting levels of triglycerides in g/L
Measured: 12 months
HDL cholesterol change between 0 and 12 months
Plasma fasting levels of HDL cholesterol in g/L
Measured: 12 months
LDL cholesterol change between 0 and 12 months
Plasma fasting levels of LDL cholesterol in g/L
Measured: 12 months
non-HDL cholesterol change between 0 and 12 months
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Measured: 12 months
Blood glucose change between 0 and 12 months
Plasma fasting levels of glucose in g/L
Measured: 12 months
HbA1c change between 0 and 12 months
Plasma fasting levels of HbA1c in percentage
Measured: 12 months
Systolic blood pressure change between 0 and 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
Measured: 12 months
Diastolic blood pressure change between 0 and 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
Measured: 12 months
Triglycerids change between 0 and 6 months
Plasma fasting levels of triglycerides in g/L
Measured: 6 months
HDL cholesterol change between 0 and 6 months
Plasma fasting levels of HDL cholesterol in g/L
Measured: 6 months
LDL cholesterol change between 0 and 6 months
Plasma fasting levels of LDL cholesterol in g/L
Measured: 6 months
non-HDL cholesterol change between 0 and 6 months
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Measured: 6 months
Blood glucose change between 0 and 6 months
Plasma fasting levels of glucose in g/L
Measured: 6 months
HbA1c change between 0 and 6 months
Plasma fasting levels of HbA1c in percentage
Measured: 6 months
Systolic blood pressure change between 0 and 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
Measured: 6 months
Diastolic blood pressure change between 0 and 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
Measured: 6 months
Change in adherence to the Mediterranean diet : Score PREDIMED
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
Measured: 12 months
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Change between 0 and 12 months in terms of perrcentage of consumption of fruits and vegetables on the recommended 400 g/day
Measured: 12 months
Change in adherence to the Mediterranean diet : Score PREDIMED
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
Measured: 6 months
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Change between 0 and 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day
Measured: 6 months
Change between 0 and 12 months of Energy intake
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire
Measured: 12 months
Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire
Measured: 12 months
Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire
Measured: 12 months
Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire
Measured: 12 months
Change between 0 and 12 months of cholesterol intake
Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire
Measured: 12 months
Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire
Measured: 12 months
Change between 0 and 12 months of sugary drinks consumption in number of glasses/day
Measured: 12 months
Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day
Measured: 12 months
Change between 0 and 6 months of sugary drinks consumption in number of glasses/day
Measured: 6 months
Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day
Measured: 6 months
Change between 0 and 12 months of tobacco consumption in number of cigarettes/day
Measured: 12 months
Change between 0 and 6 months of tobacco consumption in number of cigarettes/day
Measured: 6 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.
Measured: 12 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.
Measured: 6 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.
Measured: 12 months
Adherence to OBE-COACH program at 12 months, evaluated by the number of participation in web focus groups over the last 6 months.
Measured: 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.
Measured: 6 months
Adherence to OBE-COACH program at 6 months, evaluated by the number of participation in web focus groups over the last 6 months.
Measured: 6 months
Change between 0 and 12 months of Food impulsivity evaluated by the TFEQ21 questionnaire
Measured: 12 months
Change between 0 and 6 months of Food impulsivity evaluated by the TFEQ21 questionnaire
Measured: 6 months
Evolution between 0 and 12 months of Symptoms of anxiety, measured with the HAD questionnaire (score 0 to 21)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start2 Jan 2024
- Primary completion22 Jun 2025
- Study completion22 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marylou Para, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941651
- Sponsor's protocol ID
- K160908J
- Acronym
- TOOLBAR
- Status last verified
- May 2024
- First submitted
- 18 Jun 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT04941651
- Acronym / sponsor ID
- TOOLBAR / K160908J
- Conditions
- Overweight and Obesity
- Keywords
- Overweight patients, Obesity, Cardiometabolic risk, telenutrition, online nutritional coaching service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 22 Jun 2025 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBE-COACH program | Experimental | Behavioral: OBE-COACH program, Device: Connected devices, Device: Connected Activity TracerThe OBE-COACH experimental group: access to the complete OBE-COACH program |
| e-learning program | Active comparator | Device: Connected devices, Device: Connected Activity Tracer, Behavioral: e-learning programThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBE-COACH programOBE-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. | Behavioural | OBE-COACH program |
| Connected devicesConnected 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. | Device | OBE-COACH program, e-learning program |
| Connected Activity TracerThe 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. | Device | OBE-COACH program, e-learning program |
| e-learning programe-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) | Behavioural | e-learning program |
Primary outcome
Weight reduction of at least 5% between 0 and 12 months.
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.
46 secondary outcomes
Weight reduction of at least 5% between 0 and 6 months.
Time frame: 6 months
Weight change between 0 and 6 months
Time frame: 6 months
Weight change between 0 and 12 months
Time frame: 12 months
Waist change between 0 and 6 months
Time frame: 6 months
Waist change between 0 and 12 months
Time frame: 12 months
Triglycerids change between 0 and 12 months
Time frame: 12 months
HDL cholesterol change between 0 and 12 months
Time frame: 12 months
LDL cholesterol change between 0 and 12 months
Time frame: 12 months
non-HDL cholesterol change between 0 and 12 months
Time frame: 12 months
Blood glucose change between 0 and 12 months
Time frame: 12 months
HbA1c change between 0 and 12 months
Time frame: 12 months
Systolic blood pressure change between 0 and 12 months
Time frame: 12 months
Diastolic blood pressure change between 0 and 12 months
Time frame: 12 months
Triglycerids change between 0 and 6 months
Time frame: 6 months
HDL cholesterol change between 0 and 6 months
Time frame: 6 months
LDL cholesterol change between 0 and 6 months
Time frame: 6 months
non-HDL cholesterol change between 0 and 6 months
Time frame: 6 months
Blood glucose change between 0 and 6 months
Time frame: 6 months
HbA1c change between 0 and 6 months
Time frame: 6 months
Systolic blood pressure change between 0 and 6 months
Time frame: 6 months
Diastolic blood pressure change between 0 and 6 months
Time frame: 6 months
Change in adherence to the Mediterranean diet : Score PREDIMED
Time frame: 12 months
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Time frame: 12 months
Change in adherence to the Mediterranean diet : Score PREDIMED
Time frame: 6 months
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Time frame: 6 months
Change between 0 and 12 months of Energy intake
Time frame: 12 months
Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire
Time frame: 12 months
Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire
Time frame: 12 months
Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire
Time frame: 12 months
Change between 0 and 12 months of cholesterol intake
Time frame: 12 months
Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire
Time frame: 12 months
Change between 0 and 12 months of sugary drinks consumption in number of glasses/day
Time frame: 12 months
Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day
Time frame: 12 months
Change between 0 and 6 months of sugary drinks consumption in number of glasses/day
Time frame: 6 months
Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day
Time frame: 6 months
Change between 0 and 12 months of tobacco consumption in number of cigarettes/day
Time frame: 12 months
Change between 0 and 6 months of tobacco consumption in number of cigarettes/day
Time frame: 6 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.
Time frame: 12 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.
Time frame: 6 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.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylou Para, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OBE-COACH program, Connected devices and Connected Activity Tracer in people with Overweight and Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight reduction of at least 5% between 0 and 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.