Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-03-31
2015-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Subgroup of subjects who benefit of the e-coaching
e-coaching
connexion to a website and interaction with an automatizes system which delivers tailored recommendations over a 4 month period.
2
Subgroup of subjects who are asked to follow the conventional nutritional recommendations of the treatment of abdominal obesity and diabetes
No interventions assigned to this group
Interventions
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e-coaching
connexion to a website and interaction with an automatizes system which delivers tailored recommendations over a 4 month period.
Eligibility Criteria
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Inclusion Criteria
* Abdominal obesity defined by waist circumference ≥ 102 cm for men and ≥ 88 cm for women
* Diabetic subject with HbA1C between 5,6% and 8,5% in the month before selection (using venous or capillary blood samples)
* Subject have already received a standard nutrition education for the treatment of diabetes
* Initial Food survey showing an estimated average calorie intake between 1200 and 4000 calories
* Anti-diabetic treatments, antihypertensive or lipid-lowering therapy stable for at least 3 months (at the initial blood test)
* Subject of a weight and a stable diet, not restrictive in the past 3 months (weight change ≤ 4 kg peak to peak)
* Affiliated to the social security system or having a similar regime
* Access to Internet and usual use, possession of an email address
* Understanding and reading French
Exclusion Criteria
* Symptomatic cardiovascular disease (myocardial infarction, angina pectoris, surgical or endovascular intervention, stroke older than 6 months, symptomatic lower limb arteritis)
* Subject receiving general or local treatment that may interfere with the assessment of the primary endpoint
* Situation requiring rapid equilibration of diabetes
* Subject with any severe or acute illness which may influence the results of the study or to life-threatening
* Subject in a situation which, in the opinion of the investigator, would interfere with the optimal participation in the study or be a particular risk for the patient
* Patient who underwent obesity surgery to the exclusion of a gastric band, loosened or removed for more than a year
* For female subjects: pregnancy or lactation, or subject may become pregnant during the study
* For female subjects: subject may change hormone treatment under study (contraceptive or hormone replacement)
18 Years
75 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Boris Hansel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asistance Publique - Hopitaux de Paris
Locations
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Groupe Hospitalier Pitié Salpetrière
Paris, , France
Countries
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References
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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.
Other Identifiers
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K120901
Identifier Type: -
Identifier Source: org_study_id