ClinicalTrials.gg
Status unknownNCT05866133Updated May 19, 2023

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

An observational study in Drug Addiction, Technology Addiction and Young Adult, sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years to 34 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Drug Addiction
  • Technology Addiction
  • Young Adult

Keywords

  • Lifestyles
  • Vascular ageing
  • Obesity
03

In context

Substance-Related Disorders

2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.

This study's planned enrollment of 500 is above the median of 250 across 307 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 34 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Pulse wave velocity

    Measurement by SphygmoCor (meters/seg)

    Time frame: 1 year

Secondary outcomes

  1. Cardio Ankle Vascular Index (CAVI)

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

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. 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

    Time frame: 1 year

  5. 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.

    Time frame: 1 year

  6. 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).

    Time frame: 1 year

  7. Problem drug use

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

    Time frame: 1 year

  8. 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)

    Time frame: 1 year

  9. 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).

    Time frame: 1 year

  10. Waist and hip circumference

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

    Time frame: 1 year

  11. Body composition

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

    Time frame: 1 year

  12. International Physical Activity Questionnaire (IPAQ)

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

    Time frame: 1 year

  13. Accelerometer

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

    Time frame: 1 year

  14. 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)

    Time frame: 1 year

  15. 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)

    Time frame: 1 year

  16. Sleep disruption

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Primary Care Research Unit of Salamanca
    Salamanca, 37005, Spain
    • Manuel Angel Gomez-Marcos, Dr · Contact · magomez@usal.es · 923291100
    • 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 · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2023 (actual). Primary completion is estimated for Dec 2024, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2023
First posted
May 19, 2023
StartActual
Apr 17, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Mar 30, 2025
Last update
May 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05866133
Lead sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Collaborators
Castilla-León Health Service, Instituto de Investigación Biomédica de Salamanca
Responsible party
Sponsor
First posted
May 19, 2023
Start date
Apr 17, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
May 19, 2023

Study contacts

Manuel A Gomez-Marcos, Dr
Contact
magomez@usal.es
923291100 ext. 54757
Manuel A Gomez-Marcos, Dr
principal investigator · Primary Care Research Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion