Over WeightNCT02761538
Medico-economic Evaluation of Obesity
A study testing AVIITAM in people with Over Weight, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Over Weight
- What is being tested?
- AVIITAM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Sep 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- No Having signed an informed written consent
- No Being affiliated to social security
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud
Montpellier, 34295
Antoine AA Avignon, PU PH, +33(0)467338402, a-avignon@chu-montpellier.fr
- Recruiting
Montpellier University Hospital
Montpellier, 34295
Antoine AVIGNON, MD, 04 67 33 84 06, a-avignon@chu-montpellier.fr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Over Weight
- Being tested
- AVIITAM
- Keywords
- obesity, Overweight, ICTs, Cost-effectiveness
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVIITAMBehavioural
The purpose of the project is to test the medico economic impact related to the utilization of the Aviitam online platform in primary care.
.
.
| Study group | Role | What they receive |
|---|---|---|
| AVIITAM Group | Experimental | Utilization of the web platform Aviitam Receives: Behavioral: AVIITAM |
| Control group | No intervention | No utilization of web-platform Aviitam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss expressed in kg
Measured: 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
Measured: 24 months follow-up
Secondary outcomes (7)
Systolic blood pressure (mmHg)
Variation of resting systolic blood between M0 and M24
Measured: 24 months
Diastolic blood pressure (mmHg)
Variation of resting diastolic blood betwenn M0 and M24.
Measured: 24 months
Blood LDL Cholesterol (mmol/l)
. Variation of fasting LDL-cholesterol levels (mmol/l) between M0 and M24
.
Measured: 24 months
Blood HDL Cholesterol (mmol/l)
Variation of fasting HDL Cholesterol levels (mmol/l) between M0 and M24.
Measured: 24 months
Blood Triglycerides (mmol/l)
Variation of fasting Triglycerides levels (mmol/l) between M0 and M24
Measured: 24 months
Blood glucose (mmol/l)
Variation of fasting blood glucose levels (mmol/l) between M0 and M24
Measured: 24 months
HbAlc blood
Variation of HbAlc (mmol/mol) between M0 and M24
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start17 Sep 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over WeightStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine AA Avignon, PUPH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761538
- Sponsor's protocol ID
- UF 9534
- Status last verified
- Feb 2019
- First submitted
- 6 Oct 2015
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Complicated Obesity in Primary Care
- ClinicalTrials.gov ID
- NCT02761538
- Acronym / sponsor ID
- UF 9534
- Conditions
- Over Weight
- Keywords
- obesity, Overweight, ICTs, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVIITAM Group | Experimental | Behavioral: AVIITAMUtilization of the web platform Aviitam |
| Control group | No intervention | –No utilization of web-platform Aviitam |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- No Having signed an informed written consent
- No Being affiliated to social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVIITAMThe purpose of the project is to test the medico economic impact related to the utilization of the Aviitam online platform in primary care. . . | Behavioural | AVIITAM Group |
Primary outcome
Weight loss
Time frame: 24 months follow-up
Weight loss expressed in kg
"Quality of life" (scale)
Time frame: 24 months follow-up
Variation of scale in quality of life "Quality of life assessed by Health-Related Quality of Life (HRQOL) between M0 and M24
7 secondary outcomes
Systolic blood pressure (mmHg)
Time frame: 24 months
Diastolic blood pressure (mmHg)
Time frame: 24 months
Blood LDL Cholesterol (mmol/l)
Time frame: 24 months
Blood HDL Cholesterol (mmol/l)
Time frame: 24 months
Blood Triglycerides (mmol/l)
Time frame: 24 months
Blood glucose (mmol/l)
Time frame: 24 months
HbAlc blood
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine AA Avignon, PUPH principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVIITAM in people with Over Weight, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine AA AVIGNON, PU-PH (+33(0)467 33 84 02, a-avignon@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 24 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.