Anthropometric and Psychosocial Measurements in Vascular Disease

NCT05472480 | Unknown DMC

• 1 other identifier: E.R.ALL.2018.51
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases; Psychosocial Problem; Social Functioning

Keywords

sociology; vascular disease; anthropometric measurements; Psychosocial

Outcome Measures

Primary Outcomes (6)

• Analysis of BMI

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

  32 months

• Analysis of waist circumference

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

  32 months

• Analysis of waist / hip ratio (WHR)

  This ratio will be related to the presence of vascular disease

  32 months

• Analysis of waist / stature (WSR)

  This ratio will be related to the presence of vascular disease

  32 months

• Analysis of ABSI "a body" score shape index

  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).

  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

Study Arms (4)

Chronic Venous Disease Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements

Carotid Stenosis Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements

Abdominal Aortic Aneurysm Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements

Peripheral Artery Disease Patients

Consecutive patients admitted to Vascular Surgery Units.

Diagnostic Test: anthropometric and psychosocial measurements

Interventions

anthropometric and psychosocial measurements DIAGNOSTIC_TEST

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; Carotid Stenosis Patients; Chronic Venous Disease Patients; Peripheral Artery Disease Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Related Publications (3)

• Zhu Q, Wang XB, Yao Y, Ning CX, Chen XP, Luan FX, Zhao YL. Association between anthropometric measures and cardiovascular disease (CVD) risk factors in Hainan centenarians: investigation based on the Centenarian's health study. BMC Cardiovasc Disord. 2018 May 2;18(1):73. doi: 10.1186/s12872-018-0810-8.

  PMID: 29716519 BACKGROUND

• Dhana K, Ikram MA, Hofman A, Franco OH, Kavousi M. Anthropometric measures in cardiovascular disease prediction: comparison of laboratory-based versus non-laboratory-based model. Heart. 2015 Mar;101(5):377-83. doi: 10.1136/heartjnl-2014-306704. Epub 2014 Dec 11.

  PMID: 25502814 BACKGROUND

• Venkatrao M, Nagarathna R, Patil SS, Singh A, Rajesh SK, Nagendra H. A composite of BMI and waist circumference may be a better obesity metric in Indians with high risk for type 2 diabetes: An analysis of NMB-2017, a nationwide cross-sectional study. Diabetes Res Clin Pract. 2020 Mar;161:108037. doi: 10.1016/j.diabres.2020.108037. Epub 2020 Jan 29.

  PMID: 32004696 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases; Social Adjustment

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Raffaele Serra, M.D., Ph.D.

  University Magna Graecia of Catanzaro

  STUDY CHAIR

Central Study Contacts

Raffaele Serra, M.D.; Ph.D.

CONTACT

+3909613647380; rserra@unicz.it

Davide Costa

CONTACT

+393277404963; davide.costa@studenti.unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 25, 2022
• Study Start: July 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: August 1, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)