Hazardous Alcohol ConsumptionPhase 2NCT01075685
Evaluation of an Internet-based Intervention for Hazardous Drinkers
A Phase 2 study testing interactive online programme to reduce alcohol consumption and Minimum information in people with Hazardous Alcohol Consumption, run by Institut national de prevention et d'education pour la sante.
Trial summary
The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hazardous Alcohol Consumption
- What is being tested?
- interactive online programme to reduce alcohol consumption and Minimum information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,157 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12
Who cannot join
None listed.
About this study
The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption.
- Conditions
- Hazardous Alcohol Consumption
- Being tested
- interactive online programme to reduce alcohol consumption, Minimum information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive online programme to reduce alcohol consumptionBehavioural
The programme includes several steps:
- personalized feedback on alcohol consumption and related risks
- reviewing motivations and fears regarding drinking reduction
- analyse of drinking habits
- reduction goal setting
- follow-up tools (alcohol diary, craving scales, well-being scales)
- a final screen allowing participants to monitor their progress through graphs and automatically adapted comments.
Minimum informationBehavioural
This intervention includes:
- information about hazardous drinking
- an alcohol diary
| Study group | Role | What they receive |
|---|---|---|
| Web-based alcohol programme | Experimental | Participants could log on to their account and access the programme whenever they wanted to.
They received automated email reminders inviting them to use follow-up tools, especially the diary in order to register their alcohol intake on the previous week:
* 4 weeks after starting the programme, so that they would take advantage of the monitoring stage in case they had not spontaneously done so.
* 2 weeks later for 6-week follow-up. Receives: Behavioral: interactive online programme to reduce alcohol consumption |
| Minimum information | Placebo comparator | Participants could log on to their account and access the programme whenever they wanted to. At 6 week follow-up they received an automated email reminder inviting them to use the diary in order to register their alcohol intake on the previous week. Receives: Behavioral: Minimum information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weekly Alcohol Intake
The unit of "standard drink" is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks.
Measured: baseline and 6 weeks
Secondary outcomes (3)
Relative Change in Weekly Alcohol Intake
(6 weeks minus baseline)/baseline
Measured: baseline and 6 weeks
Category of Change in Weekly Alcohol Intake
Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are:
- clinically significant reduction in WAI, defined as a decrease of 10% or over;
- clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0);
- and no clinically significant change, which includes all other cases.
Measured: baseline and 6 weeks
Change in the Number of Excessive Drinkers
The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hazardous Alcohol ConsumptionStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut national de prevention et d'education pour la sante
- Sponsor type
- Other government
- Investigators
- Juliette Guillemont, MS, Principal investigator, Institut national de prevention et d'education pour la sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075685
- Sponsor's protocol ID
- Evalcoometre
- Status last verified
- Jan 2010
- First submitted
- 6 Jan 2010
- Last updated
- 10 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Internet-based Intervention for Hazardous Drinkers
- ClinicalTrials.gov ID
- NCT01075685
- Acronym / sponsor ID
- Evalcoometre
- Conditions
- Hazardous Alcohol Consumption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,157 participants (actual)
- Lead sponsor
- Institut national de prevention et d'education pour la santeOther government
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 10 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based alcohol programme | Experimental | Behavioral: interactive online programme to reduce alcohol consumptionParticipants could log on to their account and access the programme whenever they wanted to. They received automated email reminders inviting them to use follow-up tools, especially the diary in order to register their alcohol intake on the previous week: * 4 weeks after starting the programme, so that they would take advantage of the monitoring stage in case they had not spontaneously done so. * 2 weeks later for 6-week follow-up. |
| Minimum information | Placebo comparator | Behavioral: Minimum informationParticipants could log on to their account and access the programme whenever they wanted to. At 6 week follow-up they received an automated email reminder inviting them to use the diary in order to register their alcohol intake on the previous week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12
Key exclusion criteria (0 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 |
|---|---|---|
| interactive online programme to reduce alcohol consumptionThe programme includes several steps: * personalized feedback on alcohol consumption and related risks * reviewing motivations and fears regarding drinking reduction * analyse of drinking habits * reduction goal setting * follow-up tools (alcohol diary, craving scales, well-being scales) * a final screen allowing participants to monitor their progress through graphs and automatically adapted comments. | Behavioural | Web-based alcohol programme |
| Minimum informationThis intervention includes: * information about hazardous drinking * an alcohol diary | Behavioural | Minimum information |
Primary outcome
Change in Weekly Alcohol Intake
Time frame: baseline and 6 weeks
The unit of "standard drink" is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks.
3 secondary outcomes
Relative Change in Weekly Alcohol Intake
Time frame: baseline and 6 weeks
Category of Change in Weekly Alcohol Intake
Time frame: baseline and 6 weeks
Change in the Number of Excessive Drinkers
Time frame: baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Juliette Guillemont, MS principal investigator
Institut national de prevention et d'education pour la sante
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interactive online programme to reduce alcohol consumption and Minimum information in people with Hazardous Alcohol Consumption, run by Institut national de prevention et d'education pour la sante.
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 0 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 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Weekly Alcohol Intake (time frame: baseline and 6 weeks). 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 10 Nov 2010.