E-coaching for Type 2 Diabetes

NCT02343107 | Completed

• 1 other identifier: K120901
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Obesity; Type 2 Diabetes

Keywords

Obesity; Type 2 diabetes; Metabolic syndrome; e-coaching; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Physical skills measured by VO2max

  4 months

• Physical activity (self-administered questionnaire IPAQ)

  4 months

• Weight

  4 months

• waist circumference

  4 months

• Biological parameters: Biological parameters: HbA1c, triglycerides, HDL-C, LDL-C, AST, ALT, uric acid, hs-CRP, adiponectin

  4 months

Study Arms (2)

1

EXPERIMENTAL

Subgroup of subjects who benefit of the e-coaching

Behavioral: 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

Interventions

e-coaching BEHAVIORAL

connexion to a website and interaction with an automatizes system which delivers tailored recommendations over a 4 month period.

1

Eligibility Criteria

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

You may qualify if:

• Subject, male or female, aged 18-75 years (inclusive) who agrees to participate in the study and who gave verbal consent
• 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

You may not qualify if:

• Excessive alcohol consumption (\> 30 g / day on average)
• 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
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié Salpetrière

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 29117929 RESULT

MeSH Terms

Conditions

Obesity, Abdominal; Diabetes Mellitus, Type 2; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Boris Hansel, MD, PhD

  Asistance Publique - Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 13, 2017

Record last verified: 2015-07

Locations

FR (1)