Risk BehaviorEFICONCT03521622
Effectiveness of Counseling Interventions to Modify Risk Behaviors in Patients at the Hospital San Ignacio.
A study testing brief counseling in people with Risk Behavior, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
Randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Risk Behavior
- What is being tested?
- brief counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteColombia
- Study dates
- 15 Apr 2018to 30 May 2020
- Phase
- Interventional
- 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- candidates for scheduled surgery with a hospital stay of 3 days or less (including ambulatory surgeries) or who attend outpatient diagnostic procedures performed in surgery rooms.
- Current smokers (any tobacco product in the last month and more than 100 cigarretes in life) or risky alcohol drinkers (more than 4 or 5 alcohol standard drinks during the last year and AUDIT score between 8-15 points)
- patients with contact information
- Patients that want to participate
Who cannot join
- People who are being treated for smoking cessation or decreased consumption of alcohol.
- People with diseases that compromise their ability to understand information or their ability to verbal communication
- Patients with dependence or abuse of alcohol or other psychoactive substances other than tobacco
- Patients in action or maintenance stages of behavioral change against their risk factor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Counseling Interventions to Modify the Stage of Behavioral Change in Risk Behaviors (Smoking and Risky Alcohol Consumption) of Patient's Candidates for Surgery at the Hospital San Ignacio. Bogotá-Colombia
Randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Bogotá-Colombia
Read the detailed description
Objective: to determine the effect in the behavioral change stage of an intervention to modify risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Design: controlled clinical trial with random assignment Population: patients candidates for scheduled surgery or diagnostic procedures in surgery rooms between 19 and 64 years attending the pre-anesthetic consultation of the Hospital Universitario de San Ignacio. Interventions: brief behavioral intervention to modify risk behaviors versus information material on healthy lifestyles. Measurements: the characteristics of the study population will be described and the intervention and control groups will be compared in their basic conditions. The level of advance in the stage of change in the intervention and control arm, the proportion of people with the presence of the risk factor, as well as the decrease in the consumption of tobacco and alcohol will be compared. Expected duration: 28 months. Financing: Hospital Universitario de San Ignacio and Pontificia Universidad Javeriana. Ethical aspects: the study is adjusted to international and national standards for research projects. Under this norm, it is classified in the category of minimum risk because it is a clinical experiment with a common intervention in clinical practice.
- Conditions
- Risk Behavior
- Being tested
- brief counseling
- Keywords
- counseling, behavioral therapy, tobacco, alcohol drinking
- Medical subject headings
- Risk-Taking, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief counselingBehavioural
Brief counseling for motivated smoker 5 As model Brief counseling for not motivated smokers 5 Rs model Brief counseling for motivated risky drinkers simple advice Brief counseling for not motivated risky drinkers brief alcohol intervention
| Study group | Role | What they receive |
|---|---|---|
| brief counseling interventions | Experimental | For smoking patients the brief intervention is 5 As model for motivated patients and 5Rs for not motivated patients.
For risky alcohol drinkers the brief intervention is simple advise for motivated patients and brief intervention for not motivated patients. Receives: Behavioral: brief counseling |
| Control group | Placebo comparator | written informative material about healthy lifestyles Receives: Behavioral: brief counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of progress in the stage of behavioral change
Stages of change of Prochaska and DiClemente
Measured: one and three months after the intervention
Secondary outcomes (1)
proportion of smokers and risky alcohol drinker
proportion of smokers and risky alcohol drinker in each arm of the study
Measured: one and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 Apr 2018
- Primary completion30 May 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
- Investigators
- Luz H Alba, MD, Principal investigator, Hospital San Ignacio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521622
- Sponsor's protocol ID
- 2018/07
- Acronym
- EFICO
- Status last verified
- Mar 2024
- First submitted
- 30 Apr 2018
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ingrid A, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of brief counselling in a hospital setting for smoking cessation and risky alcohol drinking reduction: randomised clinical trial protocol. Rev Colomb Psiquiatr (Engl Ed). 2022 Apr-Jun;51(2):146-152. doi: 10.1016/j.rcpeng.2020.06.003. Epub 2022 Jun 16. English, Spanish.
PubMed 35717385Almonacid I, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of Brief Counseling in a Hospital Setting for Smoking Cessation and Risky Alcohol Drinking Reduction: Randomized Clinical Trial Protocol. Rev Colomb Psiquiatr (Engl Ed). 2020 Nov 12:S0034-7450(20)30085-8. doi: 10.1016/j.rcp.2020.06.005. Online ahead of print. English, Spanish.
PubMed 33735015
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Counseling Interventions to Modify the Stage of Behavioral Change in Risk Behaviors (Smoking and Risky Alcohol Consumption) of Patient's Candidates for Surgery at the Hospital San Ignacio. Bogotá-Colombia
- ClinicalTrials.gov ID
- NCT03521622
- Acronym / sponsor ID
- EFICO / 2018/07
- Conditions
- Risk Behavior
- Keywords
- counseling, behavioral therapy, tobacco, alcohol drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 11 May 2018 (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.
Randomized clinical trial that aims to determine the effectiveness of a counseling intervention to modify the stage of behavioral change in risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Bogotá-Colombia
Detailed description
Objective: to determine the effect in the behavioral change stage of an intervention to modify risk behaviors (smoking and risky alcohol consumption) in patients candidates for scheduled surgery or diagnostic procedures at the Hospital Universitario de San Ignacio. Design: controlled clinical trial with random assignment Population: patients candidates for scheduled surgery or diagnostic procedures in surgery rooms between 19 and 64 years attending the pre-anesthetic consultation of the Hospital Universitario de San Ignacio. Interventions: brief behavioral intervention to modify risk behaviors versus information material on healthy lifestyles. Measurements: the characteristics of the study population will be described and the intervention and control groups will be compared in their basic conditions. The level of advance in the stage of change in the intervention and control arm, the proportion of people with the presence of the risk factor, as well as the decrease in the consumption of tobacco and alcohol will be compared. Expected duration: 28 months. Financing: Hospital Universitario de San Ignacio and Pontificia Universidad Javeriana. Ethical aspects: the study is adjusted to international and national standards for research projects. Under this norm, it is classified in the category of minimum risk because it is a clinical experiment with a common intervention in clinical practice.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brief counseling interventions | Experimental | Behavioral: brief counselingFor smoking patients the brief intervention is 5 As model for motivated patients and 5Rs for not motivated patients. For risky alcohol drinkers the brief intervention is simple advise for motivated patients and brief intervention for not motivated patients. |
| Control group | Placebo comparator | Behavioral: brief counselingwritten informative material about healthy lifestyles |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- candidates for scheduled surgery with a hospital stay of 3 days or less (including ambulatory surgeries) or who attend outpatient diagnostic procedures performed in surgery rooms.
- Current smokers (any tobacco product in the last month and more than 100 cigarretes in life) or risky alcohol drinkers (more than 4 or 5 alcohol standard drinks during the last year and AUDIT score between 8-15 points)
- patients with contact information
- Patients that want to participate
Key exclusion criteria (4 listed)
- People who are being treated for smoking cessation or decreased consumption of alcohol.
- People with diseases that compromise their ability to understand information or their ability to verbal communication
- Patients with dependence or abuse of alcohol or other psychoactive substances other than tobacco
- Patients in action or maintenance stages of behavioral change against their risk factor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief counselingBrief counseling for motivated smoker 5 As model Brief counseling for not motivated smokers 5 Rs model Brief counseling for motivated risky drinkers simple advice Brief counseling for not motivated risky drinkers brief alcohol intervention | Behavioural | Control group, brief counseling interventions |
Primary outcome
the level of progress in the stage of behavioral change
Time frame: one and three months after the intervention
Stages of change of Prochaska and DiClemente
1 secondary outcome
proportion of smokers and risky alcohol drinker
Time frame: one and three months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 35717385Ingrid A, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of brief counselling in a hospital setting for smoking cessation and risky alcohol drinking reduction: randomised clinical trial protocol. Rev Colomb Psiquiatr (Engl Ed). 2022 Apr-Jun;51(2):146-152. doi: 10.1016/j.rcpeng.2020.06.003. Epub 2022 Jun 16. English, Spanish.
- Derived from this study: PubMed 33735015Almonacid I, Olaya L, Cuevas V, Castillo JS, Becerra N, Delgado J, Canas A, Alba LH. Effectiveness of Brief Counseling in a Hospital Setting for Smoking Cessation and Risky Alcohol Drinking Reduction: Randomized Clinical Trial Protocol. Rev Colomb Psiquiatr (Engl Ed). 2020 Nov 12:S0034-7450(20)30085-8. doi: 10.1016/j.rcp.2020.06.005. Online ahead of print. English, Spanish.
- Individual participant dataSharing planned: No
Related trials for Risk Behavior
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Luz H Alba, MD principal investigator
Hospital San Ignacio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief counseling in people with Risk Behavior, run by Hospital Universitario San Ignacio at 1 site in Colombia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Mar 2024. 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 Colombia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of progress in the stage of behavioral change (time frame: one and three months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521622, which also lists 2 linked publications.
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 13 Mar 2024.