Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 192 for:    Recruiting, Not yet recruiting, Available Studies | Pharmacology

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908216
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Research Center for Preventive Medicine

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : November 2020



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


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


Contacts
Layout table for location contacts
Contact: Sergey Yu Martsevich, MD, PhD +79161643690 SMartsevich@gnicpm.ru
Contact: Yulia V Lukina, MD, PhD +79161461458 yuvlu@mail.ru

Locations
Layout table for location information
Russian Federation
Yulia Lukina Recruiting
Moscow, Russian Federation, 101990
Contact: Yulia Lukina, MD, PhD    +79161461458    yuvlu@mail.ru   
Contact: Olga V Lerman, MD, PhD    +79163841143    olerman@gnicpm.ru   
Sponsors and Collaborators
National Research Center for Preventive Medicine
Investigators
Layout table for investigator information
Principal Investigator: Sergey Yu Martsevich, MD, PhD National Research Center for Preventive Medicine, Moscow, Russia, 101990

Layout table for additonal information
Responsible Party: National Research Center for Preventive Medicine
ClinicalTrials.gov Identifier: NCT03908216     History of Changes
Other Study ID Numbers: EVA
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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