E-coaching for Type 2 Diabetes
Condition: Abdominal Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Obesity, Abdominal
Study type: Interventional

Summary: 
      Abdominal obesity and its metabolic consequences, particularly type 2 diabetes, require
      personalized nutritional monitoring. Today, it is not always possible to provide patients
      with appropriate care to both, the diet plan, physical activity, stress and sleep management.
      Emerging data have shown the effectiveness of remote support (e- coaching), in order to
      increase the level of physical activity and reducing calorie intake which causes weight loss
      similar to that obtained during a face to face consultation. Compared to a food survey
      conducted by a dietician, the dietary survey MXS computer software showed similar results on
      the collection of nutritional data. Furthermore, users preferred this method of remote
      collection compared to direct interview. The investigators recently developed a tool for
      e-coaching combining this computerized dietary survey and education and support modules on
      diet and physical activity (MXS- health program) for the patients. The aim of the
      investigators' study is to compare efficacy of this new software vs usual care.
    

Detailed description: 
      Description of nutritional intervention in both groups:

      Both groups make the same visits, answer the same questionnaire and dietary surveys. Only
      nutrition and physical activity recommendations differ depending on whether the patient is
      randomized to the intervention group or the control group.

        -  Intervention group: e-coaching: patients benefit from the MXS-health support program
           including self-monitoring modules, generation of adequate nutritional recipes, education
           and support for physical activity. They receive an access code and personal password
           during the randomization visit

        -  Control group: usual recommendations: Control subjects will simply follow the usual
           nutritional recommendations provided during the monitoring of their diabetes. They will
           be informed of the possibility to benefit from the e-coaching program at the end of the
           study.

      Research hypotheses

      Assumptions related to this research are :

        -  The MXS -health e-coaching program improves adherence to nutritional recommendations in
           patients with abdominal obesity and type 2 diabetes.

        -  Adhesion to the e-coaching program can be predicted by simple criteria based on the
           characteristics of the patient and a self-administered questionnaire including
           socio-professional characteristics and the level of food impulsivity.

      Main objective To show that within four months, the e-coaching improves eating habits. The
      primary endpoint is the comparison of the changes between the first (D-20 D-2) and the second
      survey (D100 to D118) of dietary score (International Diet Quality Index) between both groups
      (e-coaching versus usual nutritional recommendations).

      Secondary objectives

        -  To show that the e-coaching provides in four months, an increase in both duration and
           abilities for physical activity,

        -  To identify predictors of the effectiveness and adherence to the e-coaching program
           which take into account the average number of weekly connections and the percentage of
           tasks required by the software (watch a video, fill a questionnaire ...) performed by
           the included patients,

        -  To evaluate the effectiveness of e-coaching on glycaemic control (HbA1c) and the
           cardiometabolic risk profile (lipid parameters, blood pressure, waist circumference,
           weight, hs-CRP, transaminases, adiponectin),

        -  To evaluate the effectiveness of e-coaching on physical fitness (VO2 max calculated
           during a graded exercise test) and the amount of physical activity performed (IPAQ
           questionnaires).
    

Intervention name(s): e-coaching
Intervention type(s): Behavioral
Intervention description(s): connexion to a website and interaction with an automatizes system which delivers tailored recommendations over a 4 month period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Type 2 diabetes; Metabolic syndrome; e-coaching; Telehealth