Clinical trial NCT02761538: Medico-economic Evaluation of Obesity
Official title: Medico-economic Evaluation of Complicated Obesity in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Over Weight
Keywords: obesity
Overweight
ICTs
Cost-effectiveness
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators developed the Aviitam® online platform. The purpose of the project is to test the medico-economic impact related to the utilization of the Aviitam online platform in primary care.

Primary objective: To assess the cost-effectiveness at 24 months follow-up of the utilization of the Aviitam® online software in primary care for people with obesity and at least one comorbidity compared to a usual follow-up in primary care.

Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in lipid profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction, profiling of patients and data mining analysis on the collected data.

Method : Overweight \& obese patients with associated comorbidities will receive a 24 months follow-up to assess the impact of the use of the online platform Aviitam®.

Practitioners will be randomized by lot between an Aviitam® group and a control group (usual care).

A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget impact analysis.

With no hypothesis on the primary endpoint, the calculation of the required number of subjects was based on the quality of life. 150 patients will be included per group Patients of the 2 groups will be assessed at baseline and after 24 months. The first day of each month, each patient included in the study will receive a questionnaire to fill online to evaluate their health care consumption in the previous month and the EQ5D questionnaire , a standardized questionnaire validated in French to assess the effects on health and to be used to calculate cost - utility.

Expected results and perspectives Proving the effectiveness of the Aviitam® online program focused on non-drug therapies and therapeutic lifestyle changes for overweight and obesity management with reduced health costs, improvement in quality of life, reduction in weight and improvement of comorbidities.

In terms of public health, the use of the platform Aviitam® can be expect to improve management of excess body weight and reduced health costs. Furthermore, Aviitam® could be a valuable tool to support healthcare professionals in outpatient therapeutic education approaches.

Detailed description: Method : Overweight \& obese patients with associated comorbidities (hypertension, prediabetes, type 2 diabetes, dyslipidemia, sleep disorders, past history of CVDs \> 6 months, stable CVD, peripheral arterial disease) will receive a 24 months follow-up to assess the impact of the use of the online platform Aviitam®.

Practitioners will be randomized by lot between an Aviitam® group and a control group (usual care).

A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget impact analysis.

With no hypothesis on the primary endpoint, the calculation of the required number of subjects was based on the quality of life. 150 patients will be included per group, for a total of 300 patients.

Eligibility criteria: Inclusion Criteria:Man or woman aged 35-65 years Having signed an informed written consent Being affiliated to social security

With a BMI between 25 and 45 kg / m2 and at least one of the following criteria associated:

* A known hypertension treated or not
* A known prediabetes \[fasting glucose between 110 and 126 mg / l or metabolic syndrome as defined in the 2009 consensus of the International Diabetes Federation and the American heart Association.
* A known type 2 diabetes, treated or not
* A known dyslipidemia treated or not
* A known sleep disorder
* A known history of cardiovascular disease\> 6 months, a stable known cardiovascular disease, peripheral arterial disease.

Exclusion Criteria:

* No Having signed an informed written consent
* No Being affiliated to social security

Primary outcomes:
measure: Weight loss
timeFrame: 24 months follow-up
measure: "Quality of life" (scale)
timeFrame: 24 months follow-up
Secondary outcomes:
measure: Systolic blood pressure (mmHg)
timeFrame: 24 months
measure: Diastolic blood pressure (mmHg)
timeFrame: 24 months
measure: Blood LDL Cholesterol (mmol/l)
timeFrame: 24 months
measure: Blood HDL Cholesterol (mmol/l)
timeFrame: 24 months
measure: Blood Triglycerides (mmol/l)
timeFrame: 24 months
measure: Blood glucose (mmol/l)
timeFrame: 24 months
measure: HbAlc blood
timeFrame: 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Antoine AA Avignon, PUPH
role: PRINCIPAL_INVESTIGATOR
References: