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Abdominal ObesityANODENCT02343107

E-coaching for Type 2 Diabetes

A study testing e-coaching in people with Abdominal Obesity and Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Abdominal Obesity, Type 2 Diabetes
What is being tested?
e-coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteFrance
Study dates
Mar 2014to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Pitié Salpetrière

    Paris, 75013

Other trials in France

About this study

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

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.

Read the 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).
Being tested
e-coaching
Keywords
Obesity, Type 2 diabetes, Metabolic syndrome, e-coaching, Telehealth
Medical subject headings
Obesity, Abdominal, Diabetes Mellitus, Type 2, Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-coachingBehavioural

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

Study groups in NCT02343107
Study groupRoleWhat they receive
1ExperimentalSubgroup of subjects who benefit of the e-coaching
Receives: Behavioral: e-coaching
2No interventionSubgroup of subjects who are asked to follow the conventional nutritional recommendations of the treatment of abdominal obesity and diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 4 months

Secondary outcomes (6)

  1. Physical skills measured by VO2max

    Variation between D0 (± 8d)) and D120-D140 of Physical skills measured by VO2max

    Measured: 4 months

  2. Physical activity (self-administered questionnaire IPAQ)

    Variation between D0 (± 8d)) and D120-D140 of Physical activity (self-administered questionnaire IPAQ)

    Measured: 4 months

  3. Weight

    Variation between D0 (± 8d)) and D120-D140 of Weight

    Measured: 4 months

  4. waist circumference

    Variation between D0 (± 8d)) and D120-D140 of waist circumference

    Measured: 4 months

  5. 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

    Measured: 4 months

  6. Blood pressure

    Variation between D0 (± 8d)) and D120-D140 of Blood pressure

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343107
Sponsor's protocol ID
K120901
Acronym
ANODE
Status last verified
Jul 2015
First submitted
15 Jan 2015
Last updated
13 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29117929

Questions about this trial

What is this clinical trial studying?

A study testing e-coaching in people with Abdominal Obesity and Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dietary score (International Diet Quality Index) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02343107, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.

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