Anthropometric and Psychosocial Measurements in Vascular Disease (ANPSYSOMEVAD)

July 22, 2022 updated by: Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

Association Between Anthropometric and Psychosocial Measurements in Vascular Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • University Magna Graecia of Catanzaro
        • Principal Investigator:
          • Davide Costa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) admitted to Vascular Surgery Units of two hospitals linked with 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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Venous Disease Patients
Consecutive patients admitted to Vascular Surgery Units.
Diagnostic test: anthropometric and psychosocial measurements
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).
Carotid Stenosis Patients
Consecutive patients admitted to Vascular Surgery Units.
Diagnostic test: anthropometric and psychosocial measurements
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).
Abdominal Aortic Aneurysm Patients
Consecutive patients admitted to Vascular Surgery Units.
Diagnostic test: anthropometric and psychosocial measurements
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).
Peripheral Artery Disease Patients
Consecutive patients admitted to Vascular Surgery Units.
Diagnostic test: anthropometric and psychosocial measurements
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of BMI
Time Frame: 32 months
This measurement (reported in kg/m^2) will be related to the presence of vascular disease
32 months
Analysis of waist circumference
Time Frame: 32 months
This measurement (reported in cm) will be related to the presence of vascular disease
32 months
Analysis of waist / hip ratio (WHR)
Time Frame: 32 months
This ratio will be related to the presence of vascular disease
32 months
Analysis of waist / stature (WSR)
Time Frame: 32 months
This ratio will be related to the presence of vascular disease
32 months
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
32 months
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
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ANTICIPATED)

July 31, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 22, 2022

First Posted (ACTUAL)

July 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.R.ALL.2018.51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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