NCT03908216

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

April 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

April 6, 2019

Last Update Submit

August 11, 2021

Conditions

Overweight and Obesity

Keywords

overweight,obesity,patients' survey,drug&non-drug treatment

Outcome Measures

Primary Outcomes (3)

  • The proportion of patients received non-pharmacological treatment recommendations

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

    on enrollment

  • The proportion of patients received pharmacological treatment recommendations

    Anti-obesity drug treatment prescribing

    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

    on enrollment

Secondary Outcomes (2)

  • Effect of overweight and obesity treatment

    April, 2019 - November, 2020

  • Patient self-assessment of previous overweight and obesity treatments effectiveness

    April, 2019 - November, 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with overweight or obesity and with CVD or with a high risk of CVD

You may qualify if:

  • 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

You may not qualify if:

  • normal weight, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yulia Lukina

Moscow, 101990, Russia

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sergey Yu Martsevich, MD, PhD

    National Research Center for Preventive Medicine, Moscow, Russia, 101990

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 9, 2019

Study Start

April 18, 2019

Primary Completion

April 3, 2021

Study Completion

April 3, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

RU(1)