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

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OBE-COACH program
Connected devices
Connected Activity Tracer
e-learning program
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring Overweight patients, Obesity, Cardiometabolic risk, telenutrition, online nutritional coaching service

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hôpital La Pitié Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OBE-COACH program

e-learning program

Arm Description

The OBE-COACH experimental group: access to the complete OBE-COACH 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight reduction of at least 5% between 0 and 6 months.
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Weight change between 0 and 6 months
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Weight change between 0 and 12 months
Weight, in Kg, measured in the same conditon at baseline and 12 months.
Waist change between 0 and 6 months
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Waist change between 0 and 12 months
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Triglycerids change between 0 and 12 months
Plasma fasting levels of triglycerides in g/L
HDL cholesterol change between 0 and 12 months
Plasma fasting levels of HDL cholesterol in g/L
LDL cholesterol change between 0 and 12 months
Plasma fasting levels of LDL cholesterol in g/L
non-HDL cholesterol change between 0 and 12 months
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Blood glucose change between 0 and 12 months
Plasma fasting levels of glucose in g/L
HbA1c change between 0 and 12 months
Plasma fasting levels of HbA1c in percentage
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
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
Triglycerids change between 0 and 6 months
Plasma fasting levels of triglycerides in g/L
HDL cholesterol change between 0 and 6 months
Plasma fasting levels of HDL cholesterol in g/L
LDL cholesterol change between 0 and 6 months
Plasma fasting levels of LDL cholesterol in g/L
non-HDL cholesterol change between 0 and 6 months
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Blood glucose change between 0 and 6 months
Plasma fasting levels of glucose in g/L
HbA1c change between 0 and 6 months
Plasma fasting levels of HbA1c in percentage
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
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
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
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
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
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
Change between 0 and 12 months of Energy intake
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire
Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire
Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire
Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire
Change between 0 and 12 months of cholesterol intake
Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire
Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire
Change between 0 and 12 months of sugary drinks consumption in number of glasses/day
Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day
Change between 0 and 6 months of sugary drinks consumption in number of glasses/day
Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day
Change between 0 and 12 months of tobacco consumption in number of cigarettes/day
Change between 0 and 6 months of tobacco consumption in number of cigarettes/day
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.
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.
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.
Adherence to OBE-COACH program at 12 months, evaluated by the number of participation in web focus groups over the last 6 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.
Adherence to OBE-COACH program at 6 months, evaluated by the number of participation in web focus groups over the last 6 months.
Change between 0 and 12 months of Food impulsivity evaluated by the TFEQ21 questionnaire
Change between 0 and 6 months of Food impulsivity evaluated by the TFEQ21 questionnaire
Evolution between 0 and 12 months of Symptoms of anxiety, measured with the HAD questionnaire (score 0 to 21)

Full Information

First Posted
June 18, 2021
Last Updated
January 6, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04941651
Brief Title
Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Acronym
TOOLBAR
Official Title
Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight patients, Obesity, Cardiometabolic risk, telenutrition, online nutritional coaching service

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OBE-COACH program
Arm Type
Experimental
Arm Description
The OBE-COACH experimental group: access to the complete OBE-COACH program
Arm Title
e-learning program
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
OBE-COACH program
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Connected devices
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Connected Activity Tracer
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
e-learning program
Intervention Description
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)
Primary Outcome Measure Information:
Title
Weight reduction of at least 5% between 0 and 12 months.
Description
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
12 months
Secondary Outcome Measure Information:
Title
Weight reduction of at least 5% between 0 and 6 months.
Description
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Time Frame
6 months
Title
Weight change between 0 and 6 months
Description
Weight, in Kg, measured in the same conditon at baseline and 6 months.
Time Frame
6 months
Title
Weight change between 0 and 12 months
Description
Weight, in Kg, measured in the same conditon at baseline and 12 months.
Time Frame
12 months
Title
Waist change between 0 and 6 months
Description
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Time Frame
6 months
Title
Waist change between 0 and 12 months
Description
Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest
Time Frame
12 months
Title
Triglycerids change between 0 and 12 months
Description
Plasma fasting levels of triglycerides in g/L
Time Frame
12 months
Title
HDL cholesterol change between 0 and 12 months
Description
Plasma fasting levels of HDL cholesterol in g/L
Time Frame
12 months
Title
LDL cholesterol change between 0 and 12 months
Description
Plasma fasting levels of LDL cholesterol in g/L
Time Frame
12 months
Title
non-HDL cholesterol change between 0 and 12 months
Description
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Time Frame
12 months
Title
Blood glucose change between 0 and 12 months
Description
Plasma fasting levels of glucose in g/L
Time Frame
12 months
Title
HbA1c change between 0 and 12 months
Description
Plasma fasting levels of HbA1c in percentage
Time Frame
12 months
Title
Systolic blood pressure change between 0 and 12 months
Description
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
Title
Diastolic blood pressure change between 0 and 12 months
Description
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
Title
Triglycerids change between 0 and 6 months
Description
Plasma fasting levels of triglycerides in g/L
Time Frame
6 months
Title
HDL cholesterol change between 0 and 6 months
Description
Plasma fasting levels of HDL cholesterol in g/L
Time Frame
6 months
Title
LDL cholesterol change between 0 and 6 months
Description
Plasma fasting levels of LDL cholesterol in g/L
Time Frame
6 months
Title
non-HDL cholesterol change between 0 and 6 months
Description
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)
Time Frame
6 months
Title
Blood glucose change between 0 and 6 months
Description
Plasma fasting levels of glucose in g/L
Time Frame
6 months
Title
HbA1c change between 0 and 6 months
Description
Plasma fasting levels of HbA1c in percentage
Time Frame
6 months
Title
Systolic blood pressure change between 0 and 6 months
Description
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
Title
Diastolic blood pressure change between 0 and 6 months
Description
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
Title
Change in adherence to the Mediterranean diet : Score PREDIMED
Description
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
Title
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Description
Change between 0 and 12 months in terms of perrcentage of consumption of fruits and vegetables on the recommended 400 g/day
Time Frame
12 months
Title
Change in adherence to the Mediterranean diet : Score PREDIMED
Description
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
Title
Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Description
Change between 0 and 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day
Time Frame
6 months
Title
Change between 0 and 12 months of Energy intake
Description
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire
Time Frame
12 months
Title
Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire
Time Frame
12 months
Title
Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire
Time Frame
12 months
Title
Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire
Time Frame
12 months
Title
Change between 0 and 12 months of cholesterol intake
Description
Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire
Time Frame
12 months
Title
Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire
Time Frame
12 months
Title
Change between 0 and 12 months of sugary drinks consumption in number of glasses/day
Time Frame
12 months
Title
Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day
Time Frame
12 months
Title
Change between 0 and 6 months of sugary drinks consumption in number of glasses/day
Time Frame
6 months
Title
Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day
Time Frame
6 months
Title
Change between 0 and 12 months of tobacco consumption in number of cigarettes/day
Time Frame
12 months
Title
Change between 0 and 6 months of tobacco consumption in number of cigarettes/day
Time Frame
6 months
Title
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
Title
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
Title
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
Title
Adherence to OBE-COACH program at 12 months, evaluated by the number of participation in web focus groups over the last 6 months.
Time Frame
12 months
Title
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.
Time Frame
6 months
Title
Adherence to OBE-COACH program at 6 months, evaluated by the number of participation in web focus groups over the last 6 months.
Time Frame
6 months
Title
Change between 0 and 12 months of Food impulsivity evaluated by the TFEQ21 questionnaire
Time Frame
12 months
Title
Change between 0 and 6 months of Food impulsivity evaluated by the TFEQ21 questionnaire
Time Frame
6 months
Title
Evolution between 0 and 12 months of Symptoms of anxiety, measured with the HAD questionnaire (score 0 to 21)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Giral, MD, PhD
Phone
01 42 17 57 73
Email
philippe.giral@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Hansel, MD, PhD
Phone
01 40 25 87 35
Email
boris.hansel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Giral, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moufida Chaaibi, CP manager
Phone
01 44 84 17 37
Email
moufida.dabbech@aphp.fr
First Name & Middle Initial & Last Name & Degree
Sofia Zemouri, CP manager
Phone
01 42 16 75 75
Email
sofia.zemouri@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal

Learn more about this trial

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

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