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

Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud (Other)
Overall Status
Recruiting
CT.gov ID
NCT05866133
Collaborator
Castilla-León Health Service (Other), Instituto de Investigación Biomédica de Salamanca (Other)
500
1
23.4
21.3

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Relationship of Addictions to Obesity, Physical Activity and Vascular Ageing in Young Adults
    Actual Study Start Date :
    Apr 17, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pulse wave velocity [1 year]

      Measurement by SphygmoCor (meters/seg)

    Secondary Outcome Measures

    1. Cardio Ankle Vascular Index (CAVI) [1 year]

      It will be determined using the Vasera VS-2000® device (not units)

    2. Pathological gambling [1 year]

      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.

    3. Internet use [1 year]

      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.

    4. Compulsive use of mobile phones [1 year]

      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

    5. Videogames use [1 year]

      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.

    6. Use or abuse of alcohol, tobacco and illegal drugs [1 year]

      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).

    7. Problem drug use [1 year]

      Drug Abuse Screening Test (DAST-20), 20 questions with dichotomous answers (Yes/No) and a cut-off point of 5

    8. Excessive alcohol consumption [1 year]

      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)

    9. Nicotine dependence [1 year]

      Fagerström test. With six questions it classifies into mild (less than 4 points), moderate (4-6 points) or severe dependence (more than 7 points).

    10. Waist and hip circumference [1 year]

      The waist and hip circumference shall be measured with a tape measure (cm).

    11. Body composition [1 year]

      The analysis of body composition shall be carried out with the impedance-meter Inbody 230® (kg).

    12. International Physical Activity Questionnaire (IPAQ) [1 year]

      Physical activity measurement using the International Physical Activity Questionnaire (IPAQ) (min/day)

    13. Accelerometer [1 year]

      Physical activity measurement using actigraph GTX3 accelerometer for 7 days (counts)

    14. Adherence to the Mediterranean diet [1 year]

      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)

    15. Sleep quality and quantity [1 year]

      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)

    16. Sleep disruption [1 year]

      The Ford Insomnia Response to Stress Test, which assesses the likelihood of sleep disruption (points)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 34 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Primary Care Research Unit of Salamanca Salamanca Spain 37005

    Sponsors and Collaborators

    • Fundacion para la Investigacion y Formacion en Ciencias de la Salud
    • Castilla-León Health Service
    • Instituto de Investigación Biomédica de Salamanca

    Investigators

    • Principal Investigator: Manuel A Gomez-Marcos, Dr, Primary Care Research Unit

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundacion para la Investigacion y Formacion en Ciencias de la Salud
    ClinicalTrials.gov Identifier:
    NCT05866133
    Other Study ID Numbers:
    • GRS 2500/B/22
    • IBYE22/00003
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2023