Relationship of Addictions to Obesity, Physical Activity and Vascular Ageing in Young Adults

Drug Addiction Clinical Trial

Official title:

Relationship of Addictions to Obesity, Physical Activity and Vascular Ageing in Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866133
• Other study ID #: GRS 2500/B/22
• Secondary ID: IBYE22/00003
• Status: Recruiting
• Start date: April 17, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2023
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: Manuel A Gomez-Marcos, Dr
• Phone: 923291100
• Email: magomez[@]usal.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a cross-sectional observational study whose objective is to analyse the relationship between behavioural addictions and drug addictions with obesity, physical activity, sedentary lifestyle, arterial stiffness and vascular ageing in young adults, since many of the lifestyles of adulthood are established early in life, and it is easier to prevent them before they start than to achieve their abandonment once they are established as unhealthy lifestyles

Description:

Behavioural addictions. Brief Questionnaire of Pathological Gambling (CBJP), Lie/Bet scale, Compulsive Internet Use Scale (CIUS), Smartphone Dependence and Addiction Scale (EDAS-18), Questionnaire of Experiences Related to Video Games (CERV). Drug addictions: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST V3.0), Drug Abuse Screening Test (DAST-20), Alcohol Use Disorders Identification Test (AUDIT) and Fagerström test. Obesity and body composition: Weight, height, waist circumference, hip circumference and Inbody 230®. Diet: Mediterranean Diet Adherence Questionnaire. Physical activity: International Physical Activity Questionnaire (IPAQ), Actigraph GTX3 accelerometer and Marshall questionnaire. Analysis of vascular structure and function and target organ lesions. Pulse wave analysis (PWA) and femoral carotid pulse wave velocity (VOPcf) (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ankle-ankle pulse wave (VOPbt) and ankle-ankle index (ABI) (Vasera VS-2000®). Retinal vascular injury (TOPCON TRC NW 200). Cardiac lesion (General electric 5000). Kidney Injury: analytical variables. Brain Injury: Montreal Cognitive Assessment (MoCA). Vascular ageing (VOPcf and VOPbt). Other variables. Basal glycaemia, HbA1c. TSH, lipid profile, creatinine and creatinine albumin index and Vit D. Measurement of blood pressure and drug consumption.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• Patients between 18 and 34 years of age who agree to participate in the study and do not meet any exclusion criteria.

Exclusion Criteria:

• Subjects who are terminally ill, who are unable to travel to health centres for the corresponding examinations, and who do not sign informed consent.

Related Conditions & MeSH terms

• Behavior, Addictive
• Drug Addiction
• Obesity
• Substance-Related Disorders
• Technology Addiction
• Young Adult

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Salamanca	Salamanca

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Castilla-León Health Service, Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity	Measurement by SphygmoCor (meters/seg)	1 year
Secondary	Cardio Ankle Vascular Index (CAVI)	It will be determined using the Vasera VS-2000® device (not units)	1 year
Secondary	Pathological gambling	Brief Questionnaire on Pathological Gambling (CBJP), with 4 dichotomous items (yes/no) referring to gambling habits, feelings of guilt, inability to give up gambling and use of household money for gambling. It is considered pathological from 2 points onwards. Also, Lie/Bet scale will also be used. It consists of two items, one of them referring to lying and the other to gambling, and will be considered problematic if both items are answered positively.	1 year
Secondary	Internet use	Compulsive Internet Use Scale (CIUS). It consists of 14 questions with a 5-point Likert scale for the answer. The cut-off point is 28.	1 year
Secondary	Compulsive use of mobile phones	Smartphone Dependence and Addiction Scale (EDAS-18). It consists of 18 questions with a 5-point Likert scale for the answer. Average scores: No dependence: = 2.23; dependence: between 2.24 and 3.5; addiction: = 3,6	1 year
Secondary	Videogames use	Video Game Related Experiences Questionnaire (VREQ), with two dimensions: negative consequences and avoidance. It consists of 17 questions with a 4-point Likert scale for the answer. The cut-off point is 26 points.	1 year
Secondary	Use or abuse of alcohol, tobacco and illegal drugs	Alcohol, Smoking and Substance Involvement Screening Test (ASSIST V3.0), with 8 items in relation to the consumption of 9 substances, categorised into three risk levels: low (0-3 points), moderate (4-26 points) and high (more than 27 points).	1 year
Secondary	Problem drug use	Drug Abuse Screening Test (DAST-20), 20 questions with dichotomous answers (Yes/No) and a cut-off point of 5	1 year
Secondary	Excessive alcohol consumption	Alcohol Use Disorders Identification Test (AUDIT), with 10 questions, allows to identify: risky use (8-15 points), harmful use (16-19 points) and dependence (more than 20 points)	1 year
Secondary	Nicotine dependence	Fagerström test. With six questions it classifies into mild (less than 4 points), moderate (4-6 points) or severe dependence (more than 7 points).	1 year
Secondary	Waist and hip circumference	The waist and hip circumference shall be measured with a tape measure (cm).	1 year
Secondary	Body composition	The analysis of body composition shall be carried out with the impedance-meter Inbody 230® (kg).	1 year
Secondary	International Physical Activity Questionnaire (IPAQ)	Physical activity measurement using the International Physical Activity Questionnaire (IPAQ) (min/day)	1 year
Secondary	Accelerometer	Physical activity measurement using actigraph GTX3 accelerometer for 7 days (counts)	1 year
Secondary	Adherence to the Mediterranean diet	Diet will be assessed with the Mediterranean Diet (MD) adherence questionnaire, developed in the PREDIMED project and consisting of 14 items with dichotomous responses.(points)	1 year
Secondary	Sleep quality and quantity	Pittsburgh Sleep Quality Index (PSQI) which assesses the quality of sleep disturbance in the last month. It is composed of 19 items. The cut-off point for poor sleep quality is 5 points or higher. (points)	1 year
Secondary	Sleep disruption	The Ford Insomnia Response to Stress Test, which assesses the likelihood of sleep disruption (points)	1 year