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NCT Number: NCT03908216

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

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

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yulia Lukina

Moscow, 101990, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The proportion of patients received non-pharmacological treatment recommendations

    Time frame: on enrollment

    Non-pharmacological methods of treatment: diet treatment, increasing physical activity

  2. The proportion of patients received pharmacological treatment recommendations

    Time frame: on enrollment

    Anti-obesity drug treatment prescribing

  3. 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 outcomes

  1. Effect of overweight and obesity treatment

    Time frame: April, 2019 - November, 2020

    Dynamics of the patient's body weight in a prospective observation

  2. 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

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Registry information

Official study 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

Acronym: EVA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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