Overweight and ObesityEVANCT03908216
Evaluation of Non-pharmacological and Pharmacological Treatment for oVerweight and Obesity in pAtients of the Outpatient Register (EVA)
An observational study of Overweight and Obesity, run by National Research Center for Preventive Medicine at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- How many people
- 295 participants
- Where
- 1 siteRussia
- Study dates
- 18 Apr 2019to 3 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with overweight or obesity and with CVD or with a high risk of CVD
Who may be able to join
- 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
Who cannot join
- normal weight, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Overweight and Obesity
- Keywords
- overweight,obesity,patients' survey,drug&non-drug treatment
- Medical subject headings
- Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients received non-pharmacological treatment recommendations
Non-pharmacological methods of treatment: diet treatment, increasing physical activity
Measured: on enrollment
The proportion of patients received pharmacological treatment recommendations
Anti-obesity drug treatment prescribing
Measured: on enrollment
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
Measured: on enrollment
Secondary outcomes (2)
Effect of overweight and obesity treatment
Dynamics of the patient's body weight in a prospective observation
Measured: April, 2019 - November, 2020
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
Measured: April, 2019 - November, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start18 Apr 2019
- Primary completion3 Apr 2021
- Study completion3 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Yu Martsevich, MD, PhD, Principal investigator, National Research Center for Preventive Medicine, Moscow, Russia, 101990
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908216
- Sponsor's protocol ID
- EVA
- Acronym
- EVA
- Status last verified
- Aug 2021
- First submitted
- 6 Apr 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03908216
- Acronym / sponsor ID
- EVA / EVA
- Conditions
- Overweight and Obesity
- Keywords
- overweight,obesity,patients' survey,drug&non-drug treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 3 Apr 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with overweight or obesity and with CVD or with a high risk of CVD
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- normal weight, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients received non-pharmacological treatment recommendations
Time frame: on enrollment
Non-pharmacological methods of treatment: diet treatment, increasing physical activity
The proportion of patients received pharmacological treatment recommendations
Time frame: on enrollment
Anti-obesity drug treatment prescribing
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
2 secondary outcomes
Effect of overweight and obesity treatment
Time frame: April, 2019 - November, 2020
Patient self-assessment of previous overweight and obesity treatments effectiveness
Time frame: April, 2019 - November, 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Yu Martsevich, MD, PhD principal investigator
National Research Center for Preventive Medicine, Moscow, Russia, 101990
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by National Research Center for Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients received non-pharmacological treatment recommendations (time frame: on enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.