Over Weight Clinical Trial
Official title:
Medico-economic Evaluation of Complicated Obesity in Primary Care
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud | Montpellier | |
| France | Montpellier University Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Weight loss | Weight loss expressed in kg | 24 months follow-up | |
| Primary | "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 | Systolic blood pressure (mmHg) | Variation of resting systolic blood between M0 and M24 | 24 months | |
| Secondary | Diastolic blood pressure (mmHg) | Variation of resting diastolic blood betwenn M0 and M24. | 24 months | |
| Secondary | Blood LDL Cholesterol (mmol/l) | . Variation of fasting LDL-cholesterol levels (mmol/l) between M0 and M24 | 24 months | |
| Secondary | Blood HDL Cholesterol (mmol/l) | Variation of fasting HDL Cholesterol levels (mmol/l) between M0 and M24. | 24 months | |
| Secondary | Blood Triglycerides (mmol/l) | Variation of fasting Triglycerides levels (mmol/l) between M0 and M24 | 24 months | |
| Secondary | Blood glucose (mmol/l) | Variation of fasting blood glucose levels (mmol/l) between M0 and M24 | 24 months | |
| Secondary | HbAlc blood | Variation of HbAlc (mmol/mol) between M0 and M24 | 24 months |
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