Medico-economic Evaluation of Obesity

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.

Study Overview

• Status: Unknown
• Conditions: Over Weight
• Intervention / Treatment: Behavioral: AVIITAM

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine AA AVIGNON, PU-PH; Phone Number: +33(0)467 33 84 02; Email: a-avignon@chu-montpellier.fr
• Study Contact Backup: Name: Antoine AA Avignon, PU PH; Phone Number: +33(0)467 33 84 02; Email: a-avignon@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University Hospital
    • Contact: Antoine AVIGNON, MD; Phone Number: 04 67 33 84 06; Email: a-avignon@chu-montpellier.fr
  • Montpellier, France, 34295
    • Recruiting
    • Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud
    • Contact: Antoine AA Avignon, PU PH; Phone Number: +33(0)467338402; Email: a-avignon@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVIITAM Group; Utilization of the web platform Aviitam	Behavioral: AVIITAM; The purpose of the project is to test the medico economic impact related to the utilization of the Aviitam online platform in primary care. . .
No Intervention: Control group; No utilization of web-platform Aviitam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (mmHg)	Variation of resting systolic blood between M0 and M24	24 months
Diastolic blood pressure (mmHg)	Variation of resting diastolic blood betwenn M0 and M24.	24 months
Blood LDL Cholesterol (mmol/l)	. Variation of fasting LDL-cholesterol levels (mmol/l) between M0 and M24 .	24 months
Blood HDL Cholesterol (mmol/l)	Variation of fasting HDL Cholesterol levels (mmol/l) between M0 and M24.	24 months
Blood Triglycerides (mmol/l)	Variation of fasting Triglycerides levels (mmol/l) between M0 and M24	24 months
Blood glucose (mmol/l)	Variation of fasting blood glucose levels (mmol/l) between M0 and M24	24 months
HbAlc blood	Variation of HbAlc (mmol/mol) between M0 and M24	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Antoine AA Avignon, PUPH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: obesity; Overweight; Cost-effectiveness; ICTs
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: UF 9534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO