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

Overweight and Obesity Clinical Trial

— TOOLBAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04941651
• Other study ID #: TOOLBAR K160908J
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: November 15, 2026

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marylou Para, PHU
• Phone: 01 40 25 84 50
• Email: marylou.para[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• OBE-COACH program
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.

Device:
• Connected devices
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 Tracer
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.

Behavioral:
• e-learning 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)

Locations

Country	Name	City	State
France	Hôpital La Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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