Medico-economic Evaluation of Obesity
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2015
CompletedFirst Submitted
Initial submission to the registry
October 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 8, 2019
February 1, 2019
4.2 years
October 6, 2015
February 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight loss
Weight loss expressed in kg
24 months follow-up
"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
24 months follow-up
Secondary Outcomes (7)
Systolic blood pressure (mmHg)
24 months
Diastolic blood pressure (mmHg)
24 months
Blood LDL Cholesterol (mmol/l)
24 months
Blood HDL Cholesterol (mmol/l)
24 months
Blood Triglycerides (mmol/l)
24 months
- +2 more secondary outcomes
Study Arms (2)
AVIITAM Group
EXPERIMENTALUtilization of the web platform Aviitam
Control group
NO INTERVENTIONNo utilization of web-platform Aviitam
Interventions
The purpose of the project is to test the medico economic impact related to the utilization of the Aviitam online platform in primary care. . .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No Having signed an informed written consent
- No Being affiliated to social security
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud
Montpellier, 34295, France
Montpellier University Hospital
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine AA Avignon, PUPH
University Hospital, Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2015
First Posted
May 4, 2016
Study Start
September 17, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 8, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share