Clinical trial NCT04941651: Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Official title: Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight patients
Obesity
Cardiometabolic risk
telenutrition
online nutritional coaching service
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Weight reduction of at least 5% between 0 and 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Weight reduction of at least 5% between 0 and 6 months.
timeFrame: 6 months
measure: Weight change between 0 and 6 months
timeFrame: 6 months
measure: Weight change between 0 and 12 months
timeFrame: 12 months
measure: Waist change between 0 and 6 months
timeFrame: 6 months
measure: Waist change between 0 and 12 months
timeFrame: 12 months
measure: Triglycerids change between 0 and 12 months
timeFrame: 12 months
measure: HDL cholesterol change between 0 and 12 months
timeFrame: 12 months
measure: LDL cholesterol change between 0 and 12 months
timeFrame: 12 months
measure: non-HDL cholesterol change between 0 and 12 months
timeFrame: 12 months
measure: Blood glucose change between 0 and 12 months
timeFrame: 12 months
measure: HbA1c change between 0 and 12 months
timeFrame: 12 months
measure: Systolic blood pressure change between 0 and 12 months
timeFrame: 12 months
measure: Diastolic blood pressure change between 0 and 12 months
timeFrame: 12 months
measure: Triglycerids change between 0 and 6 months
timeFrame: 6 months
measure: HDL cholesterol change between 0 and 6 months
timeFrame: 6 months
measure: LDL cholesterol change between 0 and 6 months
timeFrame: 6 months
measure: non-HDL cholesterol change between 0 and 6 months
timeFrame: 6 months
measure: Blood glucose change between 0 and 6 months
timeFrame: 6 months
measure: HbA1c change between 0 and 6 months
timeFrame: 6 months
measure: Systolic blood pressure change between 0 and 6 months
timeFrame: 6 months
measure: Diastolic blood pressure change between 0 and 6 months
timeFrame: 6 months
measure: Change in adherence to the Mediterranean diet : Score PREDIMED
timeFrame: 12 months
measure: Change in adherence to the Mediterranean diet : fruits and vegetables consumption
timeFrame: 12 months
measure: Change in adherence to the Mediterranean diet : Score PREDIMED
timeFrame: 6 months
measure: Change in adherence to the Mediterranean diet : fruits and vegetables consumption
timeFrame: 6 months
measure: Change between 0 and 12 months of Energy intake
timeFrame: 12 months
measure: Change between 0 and 12 months of proteins intake, in g/day, evaluated with the validated NAQA questionnaire
timeFrame: 12 months
measure: Change between 0 and 12 months of sucrose intake in g/day, evaluated with the validated NAQA questionnaire
timeFrame: 12 months
measure: Change between 0 and 12 months of lipids intake in g/day, evaluated with the validated NAQA questionnaire
timeFrame: 12 months
measure: Change between 0 and 12 months of cholesterol intake
timeFrame: 12 months
measure: Change between 0 and 12 months of calcium intake in mg/day, evaluated with the validated NAQA questionnaire
timeFrame: 12 months
measure: Change between 0 and 12 months of sugary drinks consumption in number of glasses/day
timeFrame: 12 months
measure: Change between 0 and 12 months of alcohol drinks consumption in number of glasses/day
timeFrame: 12 months
measure: Change between 0 and 6 months of sugary drinks consumption in number of glasses/day
timeFrame: 6 months
measure: Change between 0 and 6 months of alcohol drinks consumption in number of glasses/day
timeFrame: 6 months
measure: Change between 0 and 12 months of tobacco consumption in number of cigarettes/day
timeFrame: 12 months
measure: Change between 0 and 6 months of tobacco consumption in number of cigarettes/day
timeFrame: 6 months
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 12 months
measure: Adherence to OBE-COACH program at 12 months, evaluated by the number of participation in web focus groups over the last 6 months.
timeFrame: 12 months
measure: 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.
timeFrame: 6 months
measure: Adherence to OBE-COACH program at 6 months, evaluated by the number of participation in web focus groups over the last 6 months.
timeFrame: 6 months
measure: Change between 0 and 12 months of Food impulsivity evaluated by the TFEQ21 questionnaire
timeFrame: 12 months
measure: Change between 0 and 6 months of Food impulsivity evaluated by the TFEQ21 questionnaire
timeFrame: 6 months
measure: Evolution between 0 and 12 months of Symptoms of anxiety, measured with the HAD questionnaire (score 0 to 21)
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marylou Para, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: