Drug AddictionNCT05866133
Relationship of Addictions to Obesity, Physical Activity and Vascular Ageing in Young Adults
An observational study of Drug Addiction and Technology Addiction, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction, Technology Addiction, Young Adult
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2023to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Patients between 18 and 34 years of age who agree to participate in the study and do not meet any exclusion criteria.
Who cannot join
- Subjects who are terminally ill, who are unable to travel to health centres for the corresponding examinations, and who do not sign informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Primary Care Research Unit of Salamanca
Salamanca, 37005
Manuel Angel Gomez-Marcos, Dr, 923291100 ext. 54757, magomez@usal.es
Cristina Lugones-Sanchez, PhD
About this study
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.
- Conditions
- Drug Addiction, Technology Addiction, Young Adult
- Keywords
- Lifestyles, Vascular ageing, Obesity
- Medical subject headings
- Substance-Related Disorders, Technology Addiction, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measurement by SphygmoCor (meters/seg)
Measured: 1 year
Secondary outcomes (16)
Cardio Ankle Vascular Index (CAVI)
It will be determined using the Vasera VS-2000® device (not units)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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).
Measured: 1 year
Waist and hip circumference
The waist and hip circumference shall be measured with a tape measure (cm).
Measured: 1 year
Body composition
The analysis of body composition shall be carried out with the impedance-meter Inbody 230® (kg).
Measured: 1 year
International Physical Activity Questionnaire (IPAQ)
Physical activity measurement using the International Physical Activity Questionnaire (IPAQ) (min/day)
Measured: 1 year
Accelerometer
Physical activity measurement using actigraph GTX3 accelerometer for 7 days (counts)
Measured: 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)
Measured: 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)
Measured: 1 year
Sleep disruption
The Ford Insomnia Response to Stress Test, which assesses the likelihood of sleep disruption (points)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start17 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service, Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
- Investigators
- Manuel A Gomez-Marcos, Dr, Principal investigator, Primary Care Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866133
- Sponsor's protocol ID
- GRS 2500/B/22
- Other IDs
- IBYE22/00003
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Addictions to Obesity, Physical Activity and Vascular Ageing in Young Adults
- ClinicalTrials.gov ID
- NCT05866133
- Acronym / sponsor ID
- GRS 2500/B/22
- Conditions
- Drug Addiction, Technology Addiction, Young Adult
- Keywords
- Lifestyles, Vascular ageing, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service, Instituto de Investigación Biomédica de Salamanca
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients between 18 and 34 years of age who agree to participate in the study and do not meet any exclusion criteria.
Key exclusion criteria (1 listed)
- Subjects who are terminally ill, who are unable to travel to health centres for the corresponding examinations, and who do not sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse wave velocity
Time frame: 1 year
Measurement by SphygmoCor (meters/seg)
16 secondary outcomes
Cardio Ankle Vascular Index (CAVI)
Time frame: 1 year
Pathological gambling
Time frame: 1 year
Internet use
Time frame: 1 year
Compulsive use of mobile phones
Time frame: 1 year
Videogames use
Time frame: 1 year
Use or abuse of alcohol, tobacco and illegal drugs
Time frame: 1 year
Problem drug use
Time frame: 1 year
Excessive alcohol consumption
Time frame: 1 year
Nicotine dependence
Time frame: 1 year
Waist and hip circumference
Time frame: 1 year
Body composition
Time frame: 1 year
International Physical Activity Questionnaire (IPAQ)
Time frame: 1 year
Accelerometer
Time frame: 1 year
Adherence to the Mediterranean diet
Time frame: 1 year
Sleep quality and quantity
Time frame: 1 year
Sleep disruption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel A Gomez-Marcos, Dr principal investigator
Primary Care Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Addiction and Technology Addiction, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel A Gomez-Marcos, Dr (923291100 ext. 54757, magomez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.