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

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

Study Overview

• Status: Recruiting
• Conditions: Drug Addiction; Young Adult; Technology Addiction

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Manuel A Gomez-Marcos, Dr; Phone Number: 54757 923291100; Email: magomez@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37005
    • Recruiting
    • Primary Care Research Unit of Salamanca
    • Contact: Manuel Angel Gomez-Marcos, Dr; Phone Number: 54757 923291100; Email: magomez@usal.es
    • Sub-Investigator: Cristina Lugones-Sanchez, PhD
    • Sub-Investigator: Olaya Tamayo-Morales, PhD
    • Sub-Investigator: Leticia Gomez-Sanchez, PhD
    • Sub-Investigator: Sara M Vicente-Gabriel, RN
    • Sub-Investigator: Alberto Vicente-Prieto, Dr
    • Sub-Investigator: Carmen Patino-Alonso, PhD
    • Sub-Investigator: Susana Gonzalez-Sanchez, RN
    • Sub-Investigator: Cristina Agudo-Conde, RN
    • Sub-Investigator: Marta Gomez-Sanchez, Dr
    • Sub-Investigator: Sandra Conde-Martin, RN
    • Sub-Investigator: Emiliano Rodriguez-Sanchez, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Urban population assigned to the health area of Salamanca. By means of stratified random sampling by age and sex groups with replacement, based on the individual health card (TIS), subjects aged between 18 and 34 years will be selected.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Young people with addiction; Both behavioural and drug addiction will be assessed. Participants with scores consistent with an addiction will be included in this group.
Young people without addiction; Both behavioural and drug addiction will be assessed. Participants with scores not consistent with an addiction will be included in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	Measurement by SphygmoCor (meters/seg)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardio Ankle Vascular Index (CAVI)	It will be determined using the Vasera VS-2000® device (not units)	1 year
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
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
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
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
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
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
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
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
Waist and hip circumference	The waist and hip circumference shall be measured with a tape measure (cm).	1 year
Body composition	The analysis of body composition shall be carried out with the impedance-meter Inbody 230® (kg).	1 year
International Physical Activity Questionnaire (IPAQ)	Physical activity measurement using the International Physical Activity Questionnaire (IPAQ) (min/day)	1 year
Accelerometer	Physical activity measurement using actigraph GTX3 accelerometer for 7 days (counts)	1 year
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
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
Sleep disruption	The Ford Insomnia Response to Stress Test, which assesses the likelihood of sleep disruption (points)	1 year

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborators: Instituto de Investigación Biomédica de Salamanca; Castilla-León Health Service
• Investigators: Principal Investigator: Manuel A Gomez-Marcos, Dr, Primary Care Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): March 30, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Lifestyles; Vascular ageing
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Obesity; Behavior, Addictive; Technology Addiction
• Other Study ID Numbers: GRS 2500/B/22; IBYE22/00003 (Other Grant/Funding Number: IBSAL)

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