Overweight and Obesity Clinical Trial
— EVAOfficial 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
NCT number | NCT03908216 |
Other study ID # | EVA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 18, 2019 |
Est. completion date | April 3, 2021 |
Verified date | August 2021 |
Source | National Medical Research Center for Therapy and Preventive Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 295 |
Est. completion date | April 3, 2021 |
Est. primary completion date | April 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Yulia Lukina | Moscow |
Lead Sponsor | Collaborator |
---|---|
National Research Center for Preventive Medicine |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients received non-pharmacological treatment recommendations | Non-pharmacological methods of treatment: diet treatment, increasing physical activity | on enrollment | |
Primary | The proportion of patients received pharmacological treatment recommendations | Anti-obesity drug treatment prescribing | on enrollment | |
Primary | 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 | Effect of overweight and obesity treatment | Dynamics of the patient's body weight in a prospective observation | April, 2019 - November, 2020 | |
Secondary | 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 |
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