E-coaching for Type 2 Diabetes — ANODE  

Type 2 Diabetes Clinical Trial

Official title: E-coaching for Patients With Abdominal Obesity and Type 2 Diabetes : the A.N.O.D.E. Study

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Abdominal Obesity
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Obesity, Abdominal
• Type 2 Diabetes

• NCT number: NCT02343107
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: April 2015