Anthropometric and Psychosocial Measurements in Vascular Disease

Vascular Diseases Clinical Trial

— ANPSYSOMEVAD  

Official title:

Association Between Anthropometric and Psychosocial Measurements in Vascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472480
• Other study ID #: E.R.ALL.2018.51
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2022
• Source: University of Catanzaro
• Contact: Raffaele Serra, M.D.; Ph.D.
• Phone: +3909613647380
• Email: rserra[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychosocial Problem
• Social Functioning
• Vascular Diseases

Intervention

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).

Locations

Country	Name	City	State
Italy	University Magna Graecia of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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