Mediators and Moderators of a Web-based Intervention for Alcohol Use
Primary Purpose
Alcohol Drinking
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Personalised Normative Feedback
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- College student
- Alcohol use during the last year
- Aged 18 or more years
Sites / Locations
- Departamento de PsicobiologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Single PNF
Boosted PNF
Arm Description
Waiting list control receiving the PNF after the last assessment
Receives PNF after the first assessment only
Receives PNF after every assessment
Outcomes
Primary Outcome Measures
Typical alcohol use
The number of typical drink units consumed
Maximum alcohol use
The number of maximum drink units consumed
Secondary Outcome Measures
Frequency of alcohol use
Total number of drink units
Number of consequences
The number of consequences
Full Information
NCT ID
NCT04499456
First Posted
July 31, 2020
Last Updated
December 21, 2021
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04499456
Brief Title
Mediators and Moderators of a Web-based Intervention for Alcohol Use
Official Title
Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Alcohol use among college students causes health and social problems. However, even when available, many students do not access alcohol interventions. Web-based Personalized Normative Feedback (PNF) has been used to disseminate alcohol brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among this population. On the other hand, studies on PNF mediators and moderators are scarce, limiting the knowledge on the mechanisms of change and conditions in which their effects occur. Objective: to evaluate whether normative perceptions mediate, and motivation to receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students. Methods: Pragmatic randomized controlled trial among college students aged 18 and over and with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a Control group (assessment only) or to receive the updated version of the intervention (PUB 2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of drinks consumed, drinking frequency, maximum number of drinks consumed and number of consequences (secondary outcomes). Statistical analyses will consider Structural Equation Models and significance level of 5%. This study will improve knowledge on how and in which conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce the impact of alcohol problems among college students.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
685 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Waiting list control receiving the PNF after the last assessment
Arm Title
Single PNF
Arm Type
Experimental
Arm Description
Receives PNF after the first assessment only
Arm Title
Boosted PNF
Arm Type
Experimental
Arm Description
Receives PNF after every assessment
Intervention Type
Other
Intervention Name(s)
Personalised Normative Feedback
Intervention Description
The Personalised Normative Feedback provides information on 1) alcohol consumption (the number of drinks consumed, alcohol-pattern use, binge drinking); 2) normative comparisons; 3) alcohol-related consequences; 4) practical costs of alcohol consumption (money spent and calories consumed); 5) strategies to avoid or risks associated with alcohol use.
Primary Outcome Measure Information:
Title
Typical alcohol use
Description
The number of typical drink units consumed
Time Frame
30 days
Title
Maximum alcohol use
Description
The number of maximum drink units consumed
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Frequency of alcohol use
Time Frame
30 days
Title
Total number of drink units
Time Frame
30 days
Title
Number of consequences
Description
The number of consequences
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
College student
Alcohol use during the last year
Aged 18 or more years
Facility Information:
Facility Name
Departamento de Psicobiologia
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Bedendo, PhD
Phone
(011) 2149-0155
Email
andre.bedendo@unifesp.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.quantobebo.com.br
Description
Website delivering by which the intervention is delivered
Learn more about this trial
Mediators and Moderators of a Web-based Intervention for Alcohol Use
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