Skip to main content
Clinical Trials/NCT05472480
NCT05472480
Unknown
Not Applicable

Association Between Anthropometric and Psychosocial Measurements in Vascular Disease

University of Catanzaro1 site in 1 country200 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Diseases
Sponsor
University of Catanzaro
Enrollment
200
Locations
1
Primary Endpoint
Analysis of BMI
Last Updated
3 years ago

Overview

Brief Summary

This experimental study is to verify a possible correlation between vascular disease, and anthropometric, and psychosocial measurements.

Consecutive patients with vascular diseases (Chronic Venous Disease, Carotid Stenosis, Abdominal Aortic Aneurysm, Peripheral Artery Disease) will be referred to Vascular Surgery Units of two hospitals linked to Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) to be evaluated.

Since it is necessary to study the anthropometric measures and the psychosocial aspects, different types of measurements will be carried out in order to correlate them with the aforementioned vascular disease.

Detailed Description

This is a cross sectional study with the aim analyze the association between the anthropometric and psychosocial measures in the following vascular disease: Chronic Venous Disease (CVD), Carotid Stenosis (CS) , Abdominal Aortic Aneurysm (AAA) , Peripheral Artery Disease (PAD). Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) referred to Vascular Surgery Units of two hospitals (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) will be evaluated. Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ). The data will be extrapolated from a prospective analysis on patients, by inserting in a Microsoft Excel database: demographic characteristics (age, sex); anthropometric parameters (height, weight, BMI, waist circumference WHR WSR ABSI); comorbidities, with particular reference to Diabetes mellitus, Dyslipidemia, Hypertension, CRI, coronary heart disease; smoking as a risk factor; the questionnaire for psychosocial aspects (BIDQ) on cumulative score (1-15); the vascular disease under examination. Population variables (age) and continuous outcomes (weight, age, BMI, waist circumference, WHR, WSR, ABSI, BIDQ) will be analyzed by Kruskal-Wallis test, while categorical variables (males, smokers, hypertension, diabetes, insulin-dependent diabetes, dyslipidemia, CAD, renal insufficiency) with Pearson's Chi-square test. The statistically significant outcomes will be subjected to sub-analysis with t-test, to identify the comparisons responsible for statistical significance.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Catanzaro
Responsible Party
Principal Investigator
Principal Investigator

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

University of Catanzaro

Eligibility Criteria

Inclusion Criteria

  • age \>18 years, both genders, being a patient with one type of vascular disease at the time of the study.

Exclusion Criteria

  • presence of more than one contemporary vascular disease at the time of the study, to avoid overlapping of concomitant vascular disease.
  • presence of any illiteracy, or psychiatric issues that may impair understanding or self-administration of the questionnaire.
  • malignancies.

Outcomes

Primary Outcomes

Analysis of BMI

Time Frame: 32 months

This measurement (reported in kg/m\^2) will be related to the presence of vascular disease

Analysis of waist circumference

Time Frame: 32 months

This measurement (reported in cm) will be related to the presence of vascular disease

Analysis of ABSI "a body" score shape index

Time Frame: 32 months

This index (range: from "Less than -0.868" to "Greater than +0.798") will be related to the presence of vascular disease

Analysis of waist / hip ratio (WHR)

Time Frame: 32 months

This ratio will be related to the presence of vascular disease

Analysis of waist / stature (WSR)

Time Frame: 32 months

This ratio will be related to the presence of vascular disease

Administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

Time Frame: 32 months

The BIDQ comprises seven items. Items 1-2 assess appearance concern and preoccupation, while item 3 measures perceived distress, and items 4-7 investigate functional impairment and avoidance

Study Sites (1)

Loading locations...

Similar Trials