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

Overweight and Obesity Clinical Trial

— EVA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908216
• Other study ID #: EVA
• Status: Completed
• Start date: April 18, 2019
• Est. completion date: April 3, 2021

Study information

• Verified date: August 2021
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
Russian Federation	Yulia Lukina	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

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