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

August 11, 2021 updated by: National Research Center for Preventive Medicine

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

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

Study Overview

Status

Completed

Conditions

Overweight and Obesity

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.

Study Type

Observational

Enrollment (Actual)

295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Russian Federation
- - Moscow, Russian Federation, 101990
    - Yulia Lukina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with overweight or obesity and with CVD or with a high risk of CVD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients received non-pharmacological treatment recommendations Time Frame: on enrollment	Non-pharmacological methods of treatment: diet treatment, increasing physical activity	on enrollment
The proportion of patients received pharmacological treatment recommendations Time Frame: on enrollment	Anti-obesity drug treatment prescribing	on enrollment
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	on enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of overweight and obesity treatment Time Frame: April, 2019 - November, 2020	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 Time Frame: April, 2019 - November, 2020	The proportion of patients who rated the effectiveness of treatment as effective short-term, effective long-term, ineffective	April, 2019 - November, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Preventive Medicine

Investigators

Principal Investigator: Sergey Yu Martsevich, MD, PhD, National Research Center for Preventive Medicine, Moscow, Russia, 101990

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2019

Primary Completion (Actual)

April 3, 2021

Study Completion (Actual)

April 3, 2021

Study Registration Dates

First Submitted

April 6, 2019

First Submitted That Met QC Criteria