Medico-economic Evaluation of Obesity
Primary Purpose
Over Weight
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AVIITAM
Sponsored by
About this trial
This is an interventional supportive care trial for Over Weight focused on measuring obesity, Overweight, ICTs, Cost-effectiveness
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
Sites / Locations
- Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston GiraudRecruiting
- Montpellier University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AVIITAM Group
Control group
Arm Description
Utilization of the web platform Aviitam
No utilization of web-platform Aviitam
Outcomes
Primary Outcome Measures
Weight loss
Weight loss expressed in kg
"Quality of life" (scale)
Variation of scale in quality of life "Quality of life assessed by Health-Related Quality of Life (HRQOL) between M0 and M24
Secondary Outcome Measures
Systolic blood pressure (mmHg)
Variation of resting systolic blood between M0 and M24
Diastolic blood pressure (mmHg)
Variation of resting diastolic blood betwenn M0 and M24.
Blood LDL Cholesterol (mmol/l)
. Variation of fasting LDL-cholesterol levels (mmol/l) between M0 and M24
.
Blood HDL Cholesterol (mmol/l)
Variation of fasting HDL Cholesterol levels (mmol/l) between M0 and M24.
Blood Triglycerides (mmol/l)
Variation of fasting Triglycerides levels (mmol/l) between M0 and M24
Blood glucose (mmol/l)
Variation of fasting blood glucose levels (mmol/l) between M0 and M24
HbAlc blood
Variation of HbAlc (mmol/mol) between M0 and M24
Full Information
NCT ID
NCT02761538
First Posted
October 6, 2015
Last Updated
February 7, 2019
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02761538
Brief Title
Medico-economic Evaluation of Obesity
Official Title
Medico-economic Evaluation of Complicated Obesity in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Over Weight
Keywords
obesity, Overweight, ICTs, Cost-effectiveness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AVIITAM Group
Arm Type
Experimental
Arm Description
Utilization of the web platform Aviitam
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No utilization of web-platform Aviitam
Intervention Type
Behavioral
Intervention Name(s)
AVIITAM
Intervention Description
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 Outcome Measure Information:
Title
Weight loss
Description
Weight loss expressed in kg
Time Frame
24 months follow-up
Title
"Quality of life" (scale)
Description
Variation of scale in quality of life "Quality of life assessed by Health-Related Quality of Life (HRQOL) between M0 and M24
Time Frame
24 months follow-up
Secondary Outcome Measure Information:
Title
Systolic blood pressure (mmHg)
Description
Variation of resting systolic blood between M0 and M24
Time Frame
24 months
Title
Diastolic blood pressure (mmHg)
Description
Variation of resting diastolic blood betwenn M0 and M24.
Time Frame
24 months
Title
Blood LDL Cholesterol (mmol/l)
Description
. Variation of fasting LDL-cholesterol levels (mmol/l) between M0 and M24
.
Time Frame
24 months
Title
Blood HDL Cholesterol (mmol/l)
Description
Variation of fasting HDL Cholesterol levels (mmol/l) between M0 and M24.
Time Frame
24 months
Title
Blood Triglycerides (mmol/l)
Description
Variation of fasting Triglycerides levels (mmol/l) between M0 and M24
Time Frame
24 months
Title
Blood glucose (mmol/l)
Description
Variation of fasting blood glucose levels (mmol/l) between M0 and M24
Time Frame
24 months
Title
HbAlc blood
Description
Variation of HbAlc (mmol/mol) between M0 and M24
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine AA AVIGNON, PU-PH
Phone
+33(0)467 33 84 02
Email
a-avignon@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine AA Avignon, PU PH
Phone
+33(0)467 33 84 02
Email
a-avignon@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine AA Avignon, PUPH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine AA Avignon, PU PH
Phone
+33(0)467338402
Email
a-avignon@chu-montpellier.fr
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine AVIGNON, MD
Phone
04 67 33 84 06
Email
a-avignon@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Medico-economic Evaluation of Obesity
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