Hazardous Alcohol Consumption
Conditions
Brief 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.
Interventions
BEHAVIORALinteractive online programme to reduce alcohol consumption
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.
BEHAVIORALMinimum information
This intervention includes: * information about hazardous drinking * an alcohol diary
Sponsors
Institut national de prevention et d'education pour la sante
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weekly Alcohol Intake | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Change in Weekly Alcohol Intake | baseline and 6 weeks | (6 weeks minus baseline)/baseline |
| Category of Change in Weekly Alcohol Intake | baseline and 6 weeks | 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. |
| Change in the Number of Excessive Drinkers | baseline and 6 weeks | 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 |
Participant flow
Recruitment details
Recruitment period: Oct 27 to Dec 15, 2009 Recruitment was conducted via Internet.
Participants by arm
| Arm | Count |
|---|---|
| Web-based Alcohol Programme | 734 |
| Minimum Information | 413 |
| Total | 1,147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 563 | 220 |
| Overall Study | Protocol Violation | 9 | 1 |
| Overall Study | Withdrawal by Subject | 20 | 5 |
Baseline characteristics
| Characteristic | Minimum Information | Total | Web-based Alcohol Programme |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 21 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 408 Participants | 1126 Participants | 718 Participants |
| AUDIT score | 8.8 Units on a scale STANDARD_DEVIATION 1.8 | 8.7 Units on a scale STANDARD_DEVIATION 1.8 | 8.7 Units on a scale STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 130 Participants | 362 Participants | 232 Participants |
| Sex: Female, Male Male | 283 Participants | 785 Participants | 502 Participants |
| Weekly alcohol intake at baseline | 16.2 standard drinks STANDARD_DEVIATION 13.2 | 16.8 standard drinks STANDARD_DEVIATION 13.3 | 17.5 standard drinks STANDARD_DEVIATION 13.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: baseline and 6 weeks
Population: Only participants who completed the study were included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Alcohol Programme | Change in Weekly Alcohol Intake | -3.34 standard drinks | Standard Deviation 12.19 |
| Minimum Information | Change in Weekly Alcohol Intake | -1.21 standard drinks | Standard Deviation 10.86 |
p-value: 0.0279Type 3 tests of fixed effects
Secondary
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.
Time frame: baseline and 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Web-based Alcohol Programme | Category of Change in Weekly Alcohol Intake | significant reduction in weekly alcohol intake | 93 participants |
| Web-based Alcohol Programme | Category of Change in Weekly Alcohol Intake | no significant change in weekly alcohol intake | 7 participants |
| Web-based Alcohol Programme | Category of Change in Weekly Alcohol Intake | significant increase in weekly alcohol intake | 42 participants |
| Minimum Information | Category of Change in Weekly Alcohol Intake | significant reduction in weekly alcohol intake | 87 participants |
| Minimum Information | Category of Change in Weekly Alcohol Intake | no significant change in weekly alcohol intake | 13 participants |
| Minimum Information | Category of Change in Weekly Alcohol Intake | significant increase in weekly alcohol intake | 63 participants |
p-value: 0.009Chi-squared
Secondary
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
Time frame: baseline and 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Web-based Alcohol Programme | Change in the Number of Excessive Drinkers | -11 participants |
| Minimum Information | Change in the Number of Excessive Drinkers | -5 participants |
p-value: 0.082Chi-squared
Secondary
Relative Change in Weekly Alcohol Intake
(6 weeks minus baseline)/baseline
Time frame: baseline and 6 weeks
Population: Participants with weekly alcohol consumption baseline at 0 were excluded from this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Web-based Alcohol Programme | Relative Change in Weekly Alcohol Intake | -0.51 percent of baseline consumption | Standard Deviation 97.58 |
| Minimum Information | Relative Change in Weekly Alcohol Intake | 11.22 percent of baseline consumption | Standard Deviation 99.89 |
p-value: 0.0189Wilcoxon (Mann-Whitney)