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

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ClinicalTrials.gov Identifier: NCT03908216
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : August 12, 2021
Sponsor:
Information provided by (Responsible Party):
National Medical Research Center for Therapy and Preventive Medicine ( National Research Center for Preventive Medicine )

Study Description
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Brief 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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 295 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 18, 2019
Actual Primary Completion Date : April 3, 2021
Actual Study Completion Date : April 3, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with overweight or obesity and with CVD or with a high risk of CVD
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908216


Locations
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Russian Federation
Yulia Lukina
Moscow, Russian Federation, 101990
Sponsors and Collaborators
National Research Center for Preventive Medicine
Investigators
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Principal Investigator: Sergey Yu Martsevich, MD, PhD National Research Center for Preventive Medicine, Moscow, Russia, 101990
More Information
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Responsible Party: National Research Center for Preventive Medicine
ClinicalTrials.gov Identifier: NCT03908216    
Other Study ID Numbers: EVA
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Medical Research Center for Therapy and Preventive Medicine ( National Research Center for Preventive Medicine ):
overweight,obesity,patients' survey,drug&non-drug treatment
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight