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

NCT04941651 | Recruiting

• 1 other identifier: TOOLBAR K160908J
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Overweight patients; Obesity; Cardiometabolic risk; telenutrition; online nutritional coaching service

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (46)

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

  6 months

• Weight change between 0 and 6 months

  6 months

• Weight change between 0 and 12 months

  12 months

• Waist change between 0 and 6 months

  6 months

• Waist change between 0 and 12 months

  12 months

Study Arms (2)

OBE-COACH program

EXPERIMENTAL

The OBE-COACH experimental group: access to the complete OBE-COACH program

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).

Device: Connected devices; Device: Connected Activity Tracer; Behavioral: e-learning program

Interventions

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.

OBE-COACH program

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.

OBE-COACH program; e-learning program

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.

OBE-COACH program; e-learning 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)

e-learning program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital La Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marylou Para, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marylou Para, PHU

CONTACT

01 40 25 84 50; marylou.para@aphp.fr

Boris Hansel, MD, PhD

CONTACT

01 40 25 87 35; boris.hansel@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: January 2, 2024
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)