Alcohol DrinkingNCT02058355

Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students

A study testing Consequences List Feedback and Personalized Normative Feedback in people with Alcohol Drinking, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Drinking
What is being tested?: Consequences List Feedback and Personalized Normative Feedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46,142 participants
Where: 1 siteBrazil
Study dates: Mar 2014to Dec 2017
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 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

College students
Age 18-30 years
Alcohol Use during the last 3 months

Who cannot join

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Sao Paulo
São Paulo, 04023062

Other trials in Brazil

About this study

This project aims to develop and evaluate the effectiveness of an Personalized Normative Feedback (PNF) intervention via the internet, through a randomized clinical trial for alcohol consumption among Brazilian college students, as well as evaluating the most effective components of the PNF (normative and list of consequences). The sample is composed of college students aged between 18 and 30 years. Participants allocated into four different groups: control, full intervention (PNF), feedback with normative components (FN) and feedback with list of consequences (FLC). The investigators will use the dismantling design to study the most effective components. Participants will be followed-up at 1, 3 and 6 months.

Conditions: Alcohol Drinking
Being tested: Consequences List Feedback, Personalized Normative Feedback
Medical subject headings: Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Consequences List FeedbackBehavioural
Personalized Normative FeedbackBehavioural

Study groups in NCT02058355
Study group	Role	What they receive
Personalized Normative Feedback	Experimental	This group receive the complete Personalized Normative Feedback (with normative information and a list of consequences) Receives: Behavioral: Consequences List Feedback; Behavioral: Personalized Normative Feedback
Normative Feedback	Experimental	This group receive a feedback only with normative informations (without a list of consequences) Receives: Behavioral: Personalized Normative Feedback
Consequences List Feedback	Experimental	This group receive a list of consequences without normative informations Receives: Behavioral: Consequences List Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Alcohol Consumption
Measured by AUDIT questionnaire
Measured: Last 3 Months

Secondary outcomes (4)

Maximum Drinks
Maximum number of drinks reported
Measured: Last 3 months
Frequency of Alcohol Use
Measured by AUDIT questionnaire
Measured: Last 3 months
Typical Number of Drinks
Measured by AUDIT questionnaire
Measured: Last 3 months
Number of Alcohol-related Consequences
Measured by AUDIT questionnaire
Measured: Last 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2017

First posted10 Feb 2014 (estimated)
Study startMar 2014
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Alcohol DrinkingStudies 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: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Investigator
Enrolment: 46,142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02058355
Sponsor's protocol ID: PNFBrAB2013
Status last verified: Feb 2018
First submitted: 4 Feb 2014
Last updated: 12 Feb 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
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Active, not recruitingObservational study
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Hypertension, Diabetes

All Alcohol Drinking trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
ClinicalTrials.gov ID: NCT02058355
Acronym / sponsor ID: PNFBrAB2013
Conditions: Alcohol Drinking
Study type: Interventional
Recruitment status: Completed
Enrolment: 46,142 participants (actual)
Lead sponsor: Federal University of São PauloUniversity, hospital or other
Study start: Mar 2014 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 10 Feb 2014 (estimated)
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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Personalized Normative Feedback	Experimental	Behavioral: Consequences List Feedback, Behavioral: Personalized Normative FeedbackThis group receive the complete Personalized Normative Feedback (with normative information and a list of consequences)
Normative Feedback	Experimental	Behavioral: Personalized Normative FeedbackThis group receive a feedback only with normative informations (without a list of consequences)
Consequences List Feedback	Experimental	Behavioral: Consequences List FeedbackThis group receive a list of consequences without normative informations

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

College students
Age 18-30 years
Alcohol Use during the last 3 months

Key exclusion criteria (1 listed)

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
Consequences List Feedback	Behavioural	Consequences List Feedback, Personalized Normative Feedback
Personalized Normative Feedback	Behavioural	Normative Feedback, Personalized Normative Feedback

Primary outcome

Alcohol Consumption
Time frame: Last 3 Months
Measured by AUDIT questionnaire

4 secondary outcomes

Maximum Drinks
Time frame: Last 3 months
Frequency of Alcohol Use
Time frame: Last 3 months
Typical Number of Drinks
Time frame: Last 3 months
Number of Alcohol-related Consequences
Time frame: Last 3 Months

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 12 Feb 2018.

Related trials for Alcohol Drinking

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Consequences List Feedback and Personalized Normative Feedback in people with Alcohol Drinking, run by Federal University of São Paulo at 1 site in Brazil.

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 3 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: finished, as of the sponsor's last update on 12 Feb 2018. 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 Brazil. 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?

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?

Alcohol Consumption (time frame: Last 3 Months). 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 NCT02058355.

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 12 Feb 2018.