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

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: April 3, 2021

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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • National Research Center for Preventive Medicine
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Sergey Yu Martsevich, MD, PhD, Principal Investigator, National Research Center for Preventive Medicine, Moscow, Russia, 101990