Evaluation of Non-pharmacological and Pharmacological Treatment for oVerweight and Obesity in pAtients of the Outpatient Register (EVA)

Study Overview
=================
Brief Summary
-----------------
A prospective non-interventional single-centre study aimed to assess the current practice of non-pharmacological treatment and pharmacological therapy of overweight and obesity in patients with cardiovascular diseases (CVD) or with a high risk of CVD according to the patients' survey data

Detailed Description
-----------------
To interview 300 patients with a body mass index (BMI) ≥25 kg / m² of the outpatient register, who come for a primary or secondary visit to the Center. The specifically designed questionnaire contains topics about patients' self-concept of their body mass; doctors' prescriptions of therapy for obesity, patients' adherence to recommendations. A repeated short telephone interview of these patients will be conducted in 1-1.5 years after visit inclusion to clarify the dynamics of weight and methods of its correction.

Official Title
-----------------
Evaluation of Non-pharmacological and Pharmacological Treatment for Overweight and Obesity in Patients With Cardiovascular Diseases or With High Cardiovascular Risk According to the Results of Patients' Interviews Within the Outpatient Registry

Conditions
-----------------
Overweight and Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of the outpatient PROFILE registry with CVD or with a high risk of CVD (≥5%), with overweight (BMI≥25 kg/m2) or obesity (BMI≥30 kg/m2). Presence of written informed consent to participate in the study, fill in the original questionnaire and given consent to the processing of personal data Exclusion Criteria: normal weight, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients received non-pharmacological treatment recommendations | Non-pharmacological methods of treatment: diet treatment, increasing physical activity | on enrollment | 
| The proportion of patients received pharmacological treatment recommendations | Anti-obesity drug treatment prescribing | on enrollment | 
| Patients' self-concept of their body mass | The proportion of patients who assess their weight as normal weight, overweight or obesity. Patient knowledge of obesity and overweight treatment methods | on enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of overweight and obesity treatment | Dynamics of the patient's body weight in a prospective observation | April, 2019 - November, 2020 | 
| Patient self-assessment of previous overweight and obesity treatments effectiveness | The proportion of patients who rated the effectiveness of treatment as effective short-term, effective long-term, ineffective | April, 2019 - November, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight,obesity,patients' survey,drug&non-drug treatment