Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04941651

Efficacy of Telenutrition 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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OBE-COACH program

Behavioral

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

Device

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

Device

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

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Weight reduction of at least 5% between 0 and 6 months.

    Time frame: 6 months

    Weight, in Kg, measured in the same conditon at baseline and 6 months.

  2. Weight change between 0 and 6 months

    Time frame: 6 months

    Weight, in Kg, measured in the same conditon at baseline and 6 months.

  3. Weight change between 0 and 12 months

    Time frame: 12 months

    Weight, in Kg, measured in the same conditon at baseline and 12 months.

  4. Waist change between 0 and 6 months

    Time frame: 6 months

    Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest

  5. Waist change between 0 and 12 months

    Time frame: 12 months

    Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest

  6. Triglycerids change between 0 and 12 months

    Time frame: 12 months

    Plasma fasting levels of triglycerides in g/L

  7. HDL cholesterol change between 0 and 12 months

    Time frame: 12 months

    Plasma fasting levels of HDL cholesterol in g/L

  8. LDL cholesterol change between 0 and 12 months

    Time frame: 12 months

    Plasma fasting levels of LDL cholesterol in g/L

  9. non-HDL cholesterol change between 0 and 12 months

    Time frame: 12 months

    Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)

  10. Blood glucose change between 0 and 12 months

    Time frame: 12 months

    Plasma fasting levels of glucose in g/L

  11. HbA1c change between 0 and 12 months

    Time frame: 12 months

    Plasma fasting levels of HbA1c in percentage

  12. Systolic blood pressure change between 0 and 12 months

    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

  13. Diastolic blood pressure change between 0 and 12 months

    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

  14. Triglycerids change between 0 and 6 months

    Time frame: 6 months

    Plasma fasting levels of triglycerides in g/L

  15. HDL cholesterol change between 0 and 6 months

    Time frame: 6 months

    Plasma fasting levels of HDL cholesterol in g/L

  16. LDL cholesterol change between 0 and 6 months

    Time frame: 6 months

    Plasma fasting levels of LDL cholesterol in g/L

  17. non-HDL cholesterol change between 0 and 6 months

    Time frame: 6 months

    Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C)

  18. Blood glucose change between 0 and 6 months

    Time frame: 6 months

    Plasma fasting levels of glucose in g/L

  19. HbA1c change between 0 and 6 months

    Time frame: 6 months

    Plasma fasting levels of HbA1c in percentage

  20. Systolic blood pressure change between 0 and 6 months

    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

  21. Diastolic blood pressure change between 0 and 6 months

    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

  22. Change in adherence to the Mediterranean diet : Score PREDIMED

    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

  23. Change in adherence to the Mediterranean diet : fruits and vegetables consumption

    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

  24. Change in adherence to the Mediterranean diet : Score PREDIMED

    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

  25. Change in adherence to the Mediterranean diet : fruits and vegetables consumption

    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

  26. Change between 0 and 12 months of Energy intake

    Time frame: 12 months

    Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire

  27. Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire

    Time frame: 12 months

  28. Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire

    Time frame: 12 months

  29. Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire

    Time frame: 12 months

  30. Change between 0 and 12 months of cholesterol intake

    Time frame: 12 months

    Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire

  31. Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire

    Time frame: 12 months

  32. Change between 0 and 12 months of sugary drinks consumption in number of glasses/day

    Time frame: 12 months

  33. Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day

    Time frame: 12 months

  34. Change between 0 and 6 months of sugary drinks consumption in number of glasses/day

    Time frame: 6 months

  35. Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day

    Time frame: 6 months

  36. Change between 0 and 12 months of tobacco consumption in number of cigarettes/day

    Time frame: 12 months

  37. Change between 0 and 6 months of tobacco consumption in number of cigarettes/day

    Time frame: 6 months

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. Change between 0 and 12 months of Food impulsivity evaluated by the TFEQ21 questionnaire

    Time frame: 12 months

  45. Change between 0 and 6 months of Food impulsivity evaluated by the TFEQ21 questionnaire

    Time frame: 6 months

  46. Evolution between 0 and 12 months of Symptoms of anxiety, measured with the HAD questionnaire (score 0 to 21)

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Boris Hansel, MD, PhD

CONTACT

[email protected]

01 40 25 87 35

Marylou Para, PHU

CONTACT

[email protected]

01 40 25 84 50

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: TOOLBAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 28, 2021
Registry last updated
May 24, 2024

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.