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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.
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.
Research hypotheses
Assumptions related to this research are :
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subgroup of subjects who benefit of the e-coaching |
|
| 2 | No Intervention | Subgroup of subjects who are asked to follow the conventional nutritional recommendations of the treatment of abdominal obesity and diabetes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-coaching | Behavioral | connexion to a website and interaction with an automatizes system which delivers tailored recommendations over a 4 month period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| dietary score (International Diet Quality Index) | 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). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical skills measured by VO2max | Variation between D0 (± 8d)) and D120-D140 of Physical skills measured by VO2max | 4 months |
| Physical activity (self-administered questionnaire IPAQ) | Variation between D0 (± 8d)) and D120-D140 of Physical activity (self-administered questionnaire IPAQ) |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Boris Hansel, MD, PhD | Asistance Publique - Hopitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié Salpetrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29117929 | Result | Hansel B, Giral P, Gambotti L, Lafourcade A, Peres G, Filipecki C, Kadouch D, Hartemann A, Oppert JM, Bruckert E, Marre M, Bruneel A, Duchene E, Roussel R. A Fully Automated Web-Based Program Improves Lifestyle Habits and HbA1c in Patients With Type 2 Diabetes and Abdominal Obesity: Randomized Trial of Patient E-Coaching Nutritional Support (The ANODE Study). J Med Internet Res. 2017 Nov 8;19(11):e360. doi: 10.2196/jmir.7947. |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 4 months |
| Weight | Variation between D0 (± 8d)) and D120-D140 of Weight | 4 months |
| waist circumference | Variation between D0 (± 8d)) and D120-D140 of waist circumference | 4 months |
| Biological parameters: Biological parameters: HbA1c, triglycerides, HDL-C, LDL-C, AST, ALT, uric acid, hs-CRP, adiponectin | Variation between D0 (± 8d)) and D120-D140 of Biological parameters: HbA1c, triglycerides, HDL-C, LDL-C, AST, ALT, uric acid, hs-CRP, adiponectin | 4 months |
| Blood pressure | Variation between D0 (± 8d)) and D120-D140 of Blood pressure | 4 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |