Mediators and Moderators of a Web-based Intervention for Alcohol Use

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04499456
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 685
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 29.4
• Patients Per Site Per Month: 23.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking	Other: Personalised Normative Feedback	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 685 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students
• Actual Study Start Date: May 18, 2020
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Waiting list control receiving the PNF after the last assessment	Other: Personalised Normative Feedback; 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.
Experimental: Single PNF Receives PNF after the first assessment only	Other: Personalised Normative Feedback; 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.
Experimental: Boosted PNF Receives PNF after every assessment	Other: Personalised Normative Feedback; 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.

Outcome Measures

Primary Outcome Measures

1. Typical alcohol use [30 days]

   The number of typical drink units consumed

2. Maximum alcohol use [30 days]

   The number of maximum drink units consumed

Secondary Outcome Measures

1. Frequency of alcohol use [30 days]

2. Total number of drink units [30 days]

3. Number of consequences [30 days]

   The number of consequences

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• College student

• Alcohol use during the last year

• Aged 18 or more years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departamento de Psicobiologia	São Paulo		Brazil	04023062

Sponsors and Collaborators

• Federal University of São Paulo
• Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website delivering by which the intervention is delivered

Publications

None provided.

• Responsible Party: André Bedendo, Sponsor-Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT04499456
• Other Study ID Numbers: 2017/13831-9
• First Posted: Aug 5, 2020
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcohol Drinking

Study Results

No Results Posted as of Jan 11, 2022